This study will compare the effectiveness of two different treatments for preventing infection from frostbite injuries. These two treatments are A) aloe vera and B) long-acting silver wound dressings. The investigators will also study the safety and effectiveness of Dalbavancin, an FDA approved antibiotic used for treating people who develop frostbite wound infections, as well as evaluate how frostbite damage to individuals' bodies may affect how fast their kidney clear drugs from their systems.

Start Date01 Mar 2024

Sponsor / Collaborator

University of Colorado Denver

[+1]

NCT05117398 / RecruitingPhase 3IIT

Randomized Open-label Controlled Trial Evaluating a Single-dose Intravenous Dalbavancin Versus Standard Antibiotic Therapy During Catheter-related Bloodstream Infections Due to Staphylococcus Aureus

The primary objective of the study is to demonstrate, among patients with non-complicated CR-BSIs due to S. aureus, that a single-dose of intravenous (IV) dalbavancin 1500 mg is non-inferior to standard documented antibiotic therapy for 14 days according to national guidelines at DAY 30 (Long follow up visit).
As the secondary objectives, the study aims to evaluate according to treatment group:
Cure rate at DAY 14 and DAY 90 (EOS);
Mortality rate within 90 days of follow-up;
Time to negativation of blood cultures;
Patient's quality of life;
Hospitalization length of stay;
Cost-utility analyses;
Occurrence of any adverse event (AE and SAE), until Day 90 (EOS).

Start Date23 Jun 2023

Sponsor / Collaborator

Assistance Publique des Hôpitaux de Paris SA

[+3]

NCT03982030 / WithdrawnPhase 4IIT

An Open-label, Pilot Clinical Trial of Dalbavancin for the Treatment of Susceptible Gram-positive Infections Requiring Prolonged Intravenous Antibiotic Therapy

The purpose of this research is to determine if a new antibiotic called dalbavancin will work to treat and cure certain infections while reducing the need for daily antibiotics by vein.

Start Date01 Apr 2023

Sponsor / Collaborator

Wake Forest School of Medicine

100 Clinical Results associated with Dalbavancin Hydrochloride

100 Translational Medicine associated with Dalbavancin Hydrochloride

100 Patents (Medical) associated with Dalbavancin Hydrochloride

736

Literatures (Medical) associated with Dalbavancin Hydrochloride

01 Dec 2024·International journal of mental health and addiction

Examining the Predictors of Video Game Addiction According to Expertise Levels of the Players: The Role of Time Spent on Video Gaming, Engagement, Positive Gaming Perception, Social Support and Relational Health Indices

Article

Author: Yildiz Durak, Hatice ; Saritepeci, Mustafa ; Haktanir, Abdulkadir

This study aimed to examine the predictive relationship between video gaming addiction (VGA) and the level of video gaming competency among video gamers. Additionally, the role of time spent playing video games, video game engagement (VGE), video game positive perception (VGPP), social support and quality of relationships with peers were examined. We recruited 227 participants using the purposive sampling method. Of the participants, 50.20% self-identified as Novice-Amateur video gamers while 49.80% indicated being a regular-expert level players. We collected data from participants utilizing a personal and video games information form and five scales and (video game positive perception, videogame addiction scale, video engagement scale, multidimensional scale of perceived social support and relational health indices). These scales are valid and reliable instruments suitable for research purposes. The primary data analysis method was the Partial least squares- structural equation modeling (PLS-SEM). Our results demonstrated that the relationship between VGA and VGE differs based on the participants' video gaming competency level. Another important result is that VGPP has a significant positive relationship with VGA (p < 0.001), VGE (p < 0.001) and video game playing and watching activities (p < 0.001). Furthermore, an increase in the time spent on watching Twitch content is associated with an increased VGA level (p < 0.05). Finally, the time spent on playing video games has different patterns with perceptions of social support according to the level of expertise of the players. This study indicates that VGPP plays a crucial role in predicting VGA and VE and highlights the importance of considering the level of players when examining the relationship between VGA and VE. The conclusions also exhibit that the increasing popularity of esports and video game content tracking may significantly impact VGA. The role of social support in video gaming behaviors varies based on the player's level of expertise.

16 Nov 2024·JOURNAL OF CHEMOTHERAPY

Chronic antibiotic suppressive therapy with dalbavancin: a case series

Article

Author: Tordi, Sara ; Genga, Giovanni ; Albagini, Margherita ; Tommasi, Andrea ; Pallotto, Carlo ; Svizzeretto, Elisabetta ; Gidari, Anna ; Francisci, Daniela

Dalbavancin is a relatively new long-acting anti-Gram positive antimicrobial approved for the treatment of acute bacterial skin and skin structures infections. An increasing number of observational studies and case series were published on its off-label uses. Great interest is emerging about complicated cases where antibiotic treatment cannot be discontinued, and a chronic suppressive therapy is needed. We described a case series of 6 patients treated or ongoing on treatment with dalbavancin as chronic suppressive therapy (CAST) administered with the following regimen: dalbavancin 1500 mg on day 1 and 8 and then every 4 weeks. CAST median duration was 27 weeks. Five out of 6 patients reached a good clinical control of the infection (one of them completely resolved) while in one case we observed a recurrence of the infection. No adverse events were detected. Larger studies are needed to better clarify dalbavancin off-label uses and the most appropriate dose regimen.

01 Nov 2024·ANNALS OF VASCULAR SURGERY

Antibiotic Efficacy against Methicillin-Susceptible Staphylococcus aureus Biofilms on Synthetic and Biological Vascular Grafts

Article

Author: Gil-Sala, Daniel ; Muñoz, Estela ; Gavaldà, Joan ; Fernández-Hidalgo, Nuria ; Tello-Díaz, Cristina ; Gomis, Xavier ; Palau, Marta ; Bellmunt-Montoya, Sergi

BACKGROUND:

Biofilm formation is one of the greatest challenges encountered in vascular graft infections. Our aim is to compare the efficacy of 5 antibiotics against methicillin-susceptible Staphylococcus aureus (MSSA) biofilms on the surface of 4 vascular grafts.

METHODS:

In vitro study of 2 clinical MSSA strains (MSSA2 and MSSA6) and 4 vascular grafts (Dacron, Dacron-silver-triclosan (DST), Omniflow-II, and bovine pericardium). After a 24-hr incubation period, the graft samples were divided into 6 groups: growth control (no treatment), ciprofloxacin 4.5 mg/L, cloxacillin 100 mg/L, dalbavancin 300 mg/L, daptomycin 140 mg/L, and linezolid 20 mg/L. Quantitative cultures were obtained and results expressed as log₁₀ colony-forming units per milliliter (CFU/mL). Analysis of variance was performed to compare biofilm formation between the different groups.

RESULTS:

The mean ± standard deviation MSSA2 count on the growth control Dacron graft was 10.05 ± 0.31 CFU/mL. Antibiotic treatment achieved a mean reduction of 45%; ciprofloxacin was the most effective antibiotic (64%). Baseline MSSA2 counts were very low on the DST (0.50 ± 1.03 CFU/mL) and Omniflow-II (0.33 ± 0.78 CFU/mL) grafts. On the bovine pericardium patch, the count was 9.87 ± 0.50 CFU/mL, but this was reduced by a mean of 45% after antibiotic treatment (61% for ciprofloxacin). The mean MSSA6 count on the growth control Dacron graft was 9.63 ± 0.53 CFU/mL. Antibiotics achieved a mean reduction of 48%, with ciprofloxacin performing best (67% reduction). The baseline MSSA6 count on the DST graft was 8.54 ± 0.73 CFU/mL. Antibiotics reduced biofilm formation by 72%; cloxacillin was the most effective treatment (86%). The MSSA6 count on the untreated Omniflow-II graft was 1.17 ± 1.52 CFU/mL. For the bovine pericardium patch, it was 8.98 ± 0.67 CFU/mL. The mean reduction after antibiotic treatment was 46%, with cloxacillin achieving the greatest reduction (68%).

CONCLUSIONS:

In this in vitro study, ciprofloxacin and cloxacillin performed best at reducing biofilms formed by clinical MSSA strains on the surface of biological and synthetic vascular grafts.

News (Medical) associated with Dalbavancin Hydrochloride

14 Oct 2022

·www.ema.europa.eu

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 October 2022

10 new medicines recommended for approval EMA’s human medicines committee ( CHMP ) recommended 10 medicines for approval at its October 2022 meeting. The CHMP recommended granting a marketing authorisation for Dengue Tetravalent Vaccine (Live, Attenuated) Takeda for the prevention of dengue virus serotypes 1, 2, 3 and 4 in people from four years of age. Dengue is a mosquito-borne tropical disease caused by the dengue virus, leading to mild flu-like symptoms in most people. However, a small number of patients develop severe disease, with potentially fatal bleeding and organ damage. The global estimated death rate is 20,000 to 25,000 per year, primarily in children. Dengue tetravalent vaccine prevents fever, severe disease and hospitalisation caused by any of the four serotypes of the dengue virus. This vaccine received an EMA recommendation under the EU Medicines for all (EU-M4All) programme, a mechanism that allows the CHMP to assess medicines that are intended for use in low- and middle-income countries outside of the European Union (EU). Simultaneously, the vaccine has also received a positive opinion for use in the EU, under the trade name Qdenga . See more information in the news announcement in the grid below. The committee adopted a positive opinion for a marketing authorisation under exceptional circumstances for the advanced therapy medicinal product (ATMP) Ebvallo * (tabelecleucel) for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease. This ATMP is intended for adult and paediatric patients who experience a serious complication following solid organ transplantation or bone marrow transplantation. Ebvallo was supported through EMA's PRIority MEdicines (PRIME) scheme, which provides early and enhanced scientific and regulatory support to medicines that have a particular potential to address patients' unmet medical needs. See more information in the news announcement in the grid below. Eladynos (abaloparatide) received a positive opinion for the treatment of osteoporosis in postmenopausal women at increased risk of fractures. The committee recommended granting a marketing authorisation under exceptional circumstances for Livmarli * (maralixibat chloride) intended for the treatment of cholestatic pruritus (itching) in adult and paediatric patients from two months of age with Alagille syndrome, an inherited condition in which bile builds up in the liver. The CHMP gave a positive opinion for Locametz (gozetotide), which is intended for the diagnosis of prostate cancer. The committee adopted a positive opinion for Pluvicto (lutetium ( 177 Lu) vipivotide tetraxetan) for the treatment of prostate cancer. Spevigo (spesolimab) received a positive opinion for a conditional marketing authorisation for the treatment of flares in adult patients with generalised pustular psoriasis, a skin disorder that consists of pus spots surrounded by areas of red skin. The committee adopted positive opinions for three generic medicines : Dimethyl fumarate Teva (dimethyl fumarate), indicated for the treatment of adult and paediatric patients aged 13 years and older with multiple sclerosis, a chronic disease affecting the central nervous system. Pemetrexed Baxter (pemetrexed) for the treatment of malignant pleural mesothelioma, a rare cancer of the lining around the lungs, and non-small cell lung cancer. Plerixafor Accord (plerixafor) for the treatment of adults and children with lymphoma and multiple myeloma, two types of white blood cells cancers. Recommendations on extensions of therapeutic indication for four medicines The committee recommended four extensions of indication for medicines that are already authorised in the EU: Brukinsa , Libtayo , Lyumjev and Xydalba . Withdrawals of initial applications The applications for marketing authorisation for biosimilar medicines Tuznue and Hervelous were withdrawn by the applicant during the re-examination of the negative opinions that the committee adopted at its May 2022 meeting. These medicines were intended for the treatment of certain forms of breast cancer and gastric (stomach) cancer. A question-and-answer document on the withdrawals is available in the grid below. COVID-19 update The committee recommended converting the conditional marketing authorisation of the COVID-19 vaccine Vaxzevria to a standard marketing authorisation . Agenda and minutes The agenda of the October 2022 CHMP meeting is published on EMA's website. Minutes of the September 2022 CHMP meeting will be published in the coming weeks. CHMP statistics Key figures from the October 2022 CHMP meeting are represented in the graphic below. * This product was designated as an orphan medicine during its development. Orphan designations are reviewed by EMA's Committee for Orphan Medicinal Products ( COMP ) at the time of approval to determine whether the information available to date allows maintaining the medicine’s orphan status and granting the medicine ten years of market exclusivity . Positive recommendations on new medicines Name of medicine Ebvallo International non-proprietary name (INN) tabelecleucel Marketing-authorisation applicant Atara Biotherapeutics Ireland Limited Therapeutic indication Treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease More information Ebvallo: Pending EC decision News announcement: First therapy to treat transplant patients with post-transplant lymphoproliferative disease Name of medicine Eladynos INN abaloparatide Marketing-authorisation applicant Radius Health Ireland Ltd Therapeutic indication Treatment of osteoporosis in postmenopausal women at increased risk of fracture More information Eladynos: Pending EC decision Name of medicine Livmarli INN maralixibat chloride Marketing-authorisation applicant Mirum Pharmaceuticals International B.V. Therapeutic indication Treatment of cholestatic pruritus in patients with Alagille syndrome More information Livmarli: Pending EC decision Name of medicine Locametz INN gozetotide Marketing-authorisation applicant Novartis Europharm Limited Therapeutic indication Diagnosis of prostate cancer More information Locametz: Pending EC decision Name of medicine Qdenga Common name dengue tetravalent vaccine (live, attenuated) Marketing-authorisation applicant Takeda GmbH Therapeutic indication Prevention of dengue disease More information Qdenga: Pending EC decision Name of medicine Pluvicto INN lutetium (177Lu) vipivotide tetraxetan Marketing-authorisation applicant Novartis Europharm Limited Therapeutic indication Treatment of prostate cancer More information Pluvicto: Pending EC decision Name of medicine Spevigo INN spesolimab Marketing-authorisation applicant Boehringer Ingelheim International GmbH Therapeutic indication Treatment of flares in adult patients with generalised pustular psoriasis More information Spevigo: Pending EC decision Positive recommendations on new generic medicines Name of medicine Dimethyl fumarate Teva INN dimethyl fumarate Marketing-authorisation holder TEVA GmbH Therapeutic indication Treatment of multiple sclerosis More information Dimethylfumarate Teva: Pending EC decision Name of medicine Pemetrexed Baxter INN pemetrexed Marketing-authorisation applicant Baxter Holding B.V. Therapeutic indication Treatment of malignant pleural mesothelioma and non-small cell lung cancer More information Pemetrexed Baxter: Pending EC decision Name of medicine Plerixafor Accord INN plerixafor Marketing-authorisation applicant Accord Healthcare S.L.U. Therapeutic indication Treatment of lymphoma and multiple myeloma More information To be published shortly Positive recommendations on extensions of indications Name of medicine Brukinsa INN zanubrutinib Marketing-authorisation holder BeiGene Ireland Ltd More information Brukinsa: Pending EC decision Name of medicine Libtayo INN cemiplimab Marketing-authorisation holder Regeneron Ireland Designated Activity Company (DAC) More information Libtayo: Pending EC decision Name of medicine Lyumjev INN insulin lispro Marketing-authorisation holder Eli Lilly Nederland B.V. More information Lyumjev: Pending EC decision Name of medicine Xydalba INN dalbavancin Marketing-authorisation holder AbbVie Deutschland GmbH & Co. KG More information Xydalba: Pending EC decision Withdrawals of initial marketing authorisation applications Name of medicine Hervelous INN trastuzumab Marketing-authorisationapplicant Prestige Biopharma Belgium More information Hervelous: Withdrawn application Name of medicine Tuznue INN trastuzumab Marketing-authorisationapplicant Prestige Biopharma Belgium More information Tuznue: Withdrawn application Positive recommendations on medicines for use outside the European Union Name of medicine Dengue Tetravalent Vaccine (Live, Attenuated) Takeda Common name dengue tetravalent vaccine (live, attenuated) More information Dengue Tetravalent Vaccine (Live, Attenuated) Takeda News announcement: New vaccine to protect people in the EU and worldwide against dengue Other updates List item Overview of (invented) names reviewed in September 2022 by the Name Review Group (NRG) adopted at the CHMP meeting of 10-13 October 2022 (PDF/142.16 KB) (new) Adopted First published: 14/10/2022 EMA/825713/2022 List item Scientific advice and protocol assistance adopted during the CHMP meeting 10-13 October 2022 (PDF/242.62 KB) (new) Adopted First published: 14/10/2022 EMA/CHMP/SAWP/827118/2022

VaccineBiosimilar

22 Jun 2022

·www.prnewswire.com

Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Market to Surpass US$ 20,450.6 Million by 2030 - Coherent Market Insights

SEATTLE, June 22, 2022 /PRNewswire/ -- According to Coherent Market Insights, the global acute bacterial skin and skin structure infections (ABSSSI) market is estimated to be valued at US$ 10,263.5 million in 2022 and is expected to exhibit a CAGR of 9.0% over the forecast period (2022-2030). Key Trends and Analysis of the Global Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Market: Key trends in market include widespread presence of acute bacterial skin and skin structure infections (ABSSSI); increasing approval of novel drugs for acute bacterial skin and skin structure infections (ABSSSI), and increasing collaborations, acquisitions, and partnerships among key players. These key trends are expected to aid in growth of the global acute bacterial skin and skin structure infections (ABSSSI) market. According to an article published in the PLOS One journal, a peer-reviewed open access scientific journal in July 2020, the lifetime prevalence of skin and soft tissue infections (SSTI), a type of ABSSSI in people who inject drugs (PWID) in London was found to be 64% (abscess and/or cellulitis), on the basis of data collected between October 2017 and March 2019. Moreover, rapid research and development in the field of acute bacterial skin and skin structure infections (ABSSSI) for development of novel treatment for the same is expected to fuel market growth over the forecast period. For instance, in January 2022, Paladin Labs Inc., a subsidiary of Endo International plc launched Xydalba (dalbavancin for injection), in Canada. Xydalba is a 30-minute intravenous (IV) therapy, which can be administered as a single- or two-dose regimen for treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults. Furthermore, key players operating in the global acute bacterial skin and skin structure infections (ABSSSI) market are focusing on adoption of inorganic growth strategies such as partnerships, acquisitions, collaborations, and others in order to expand their market presence in the global market. For instance, in May 2020, Advanz Pharma, a U.K.-based pharmaceutical company, announced that it had completed the acquisition of Correvio Pharma Corp., a Canada-based specialty pharmaceutical company whose product portfolio includes licensed medicines such as XYDALBA (dalbavancin hydrochloride) indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults. Request Sample Copy of this Report @ Key Market Takeaways: Global acute bacterial skin and skin structure infections (ABSSSI) market is expected to exhibit a CAGR of 9.0% over the forecast period, owing to rising focus of market players on regulatory approvals for novel acute bacterial skin and skin structure infections (ABSSSI) therapeutics. For instance, in July 2021, AbbVie Inc. ., a U.S. based pharmaceutical company announced that it has received the U.S. Food and Drug Administration (USFDA) approval for its drug Dalvance (dalbavancin), administered as an intravenous (IV) infusion for the treatment of pediatric patients with ABSSSI caused by methicillin-resistant Staphylococcus aureus (MRSA) and other gram-positive bacteria. Among infection type, community acquired ABSSSI segment is expected to account for the largest market share in 2022, owing to rising drug launches by market players for treatment of community acquired acute bacterial skin and skin structure infections (ABSSSI). For instance, in February 2021, Paratek Pharmaceuticals, Inc., a U.S.-based pharmaceutical company announced that it is expanding commercial launch of its tetracycline-class oral antibiotic Nuzyra (omadacycline) into the community setting. Nuzyra is indicated for the treatment of adults with acute skin and skin structure infections (ABSSSI). Key players operating in the global acute bacterial skin and skin structure infections (ABSSSI) market include Merck & Co., Inc., Pfizer, Inc., GlaxoSmithKline plc., Teva Pharmaceutical Industries Ltd., Paratek Pharmaceuticals, Inc., Melinta Therapeutics, Inc., Arrevus, Inc., AbbVie, Inc., Aurobindo Pharma Ltd., Amneal Pharmaceuticals LLC, Sun Pharmaceutical Industries Ltd., Accord Healthcare Ltd., Intas Pharmaceuticals Ltd., Fresenius SE & Co. KGaA, Sandoz Inc., Glenmark Pharmaceuticals Ltd, and Cadila Healthcare Ltd. Request for Customization @ Detailed Segmentation: Global Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Market, By Drug Type: Oral & Parenteral Antibiotics Vancomycin Linezolid Clindamycin Ceftaroline Daptomycin Dalbavancin Tedizolid Others (Rifampin, Doxycycline, Minocycline, and Trimethoprim-Sulfa Methoxazol, among others) Topical Antibiotics Hydrogen Peroxide Fusidic Acid Mupirocin Retapamulin Povidone-Iodine Global Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Market, By Infection Type: Hospital Acquired ABSSSI Community Acquired ABSSSI Global Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Market, By Route of Administration: Oral Parenteral Topical Global Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Market, By Distribution Channel: Hospital Pharmacies Retail Pharmacies Online Pharmacies Global Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Market, By Region: North America By Country: U.S. Canada Europe By Country: U.K. Germany Italy France Spain Russia Rest of Europe Asia Pacific By Country: China India Japan ASEAN Australia South Korea Rest of Asia Pacific Latin America By Country: Brazil Mexico Argentina Rest of Latin America Middle East & Africa By Country: GCC Countries Israel South Africa Rest of Middle East & Africa Buy this Complete Report Now @ Find related trending report below: North America and Europe Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Market , by Drug Type (Oral & Parenteral Antibiotics (Vancomycin, Linezolid, Clindamycin, Ceftaroline, Daptomycin, Dalbavancin, Tedizolid, and Others) and Topical Antibiotics (Hydrogen Peroxide, Fusidic Acid, Mupirocin, Retapamulin, and Povidone-Iodine)), by Infection Type (Hospital Acquired ABSSSI and Community Acquired ABSSSI), by Route of Administration (Oral, Parenteral, and Topical), by Distribution Channel (Hospital Pharmacies, Retail Pharmacies, and Online Pharmacies), and by Region (North America, and Europe) - Size, Share, Outlook, and Opportunity Analysis, 2020 - 2027 About Us: Coherent Market Insights is a global market intelligence and consulting organization focused on assisting our plethora of clients achieve transformational growth by helping them make critical business decisions. We are headquartered in India, having sales office at global financial capital in the U.S. and sales consultants in United Kingdom and Japan. Our client base includes players from across various business verticals in over 57 countries worldwide. We create value for clients through our highly reliable and accurate reports. We are also committed in playing a leading role in offering insights in various sectors post-COVID-19 and continue to deliver measurable, sustainable results for our clients. Contact Us: Mr. Shah Senior Client Partner – Business Development Coherent Market Insights Phone: US: +1-206-701-6702 UK: +44-020-8133-4027 Japan: +81-050-5539-1737 India: +91-848-285-0837 Email: [email protected] Website: Follow Us: LinkedIn | Twitter Logo: SOURCE Coherent Market Insights

AcquisitionCollaborate

23 Jul 2021

·www.biospace.com

FDA Greenlights AbbVie’s Antibiotic Dalvance for Acute Skin Infections in Children

Smith Collection/Gado/Getty Images The U.S. Food and Drug Administration (FDA) approved AbbVie’s Dalvance (dalbavancin) for acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients as young as newborns. The drug is given in a single-dose as a 30-mintue intravenous infusion. This approval is specifically for the treatment of ABSSSI caused by certain susceptible Gram-positive bacteria in children, including infections caused by methicillin-resistant Staphylococcus aureus (MRSA). This is not the only recent approval for this indication. In March 2021, the FDA approved Melinta Therapeutics’ Kimrysa for that indication, which became available this month. That is a one-hour, single-dose regimen approved for adults. ABSSSI affect about 14 million people in the U.S. annually, resulting in more than 3 million emergency room visits. They cause U.S. hospitals about $4 billion annually, with a 4-day average length of stay. ABSSSI are common, but can be life-threatening, particularly in children. The most common types of skin infections seen by pediatricians are cutaneous abscesses and cellulitis. In the U.S., ABSSSI causes 3 million pediatric visits to doctors or emergency rooms each year. “Serious infections in children can be difficult to treat and the impact of ABSSSI in children is significant, as these infections often require IV antibiotics, resulting in hospitalization,” said Margaret Burroughs, medical director, infectious diseases, AbbVie. “This pediatric approval for Dalvance as a single-dose provides a meaningful contribution to the treatment of children and infants with ABSSSI.” The approval was built on data from a trial that evaluated Dalvance in pediatric patients from newborn to less than 18 years of age with ABSSSI, as well as three pharmacokinetic studies. In the clinical trial, the safety and efficacy were tested along with intravenous vancomycin for methicillin-resistant Gram-positive infections, or intravenous oxacillin or flucloxacillin for methicillin-susceptible Gram-positive infections. The analysis in the pediatric trial was on 183 patients with ABSSSI in the Modified Intent-to-Treat (mITT) population. That included all the patients who had been randomized to receive any dose of the drug who had ABSSSI caused by Gram-positive bacteria. They looked at an early clinical response at 48 to 72 hours based on a greater than or equal to 20% decrease in size of the lesions compared to baseline as well as on the need for rescue antibacterial therapy for children who were three months of age and older. In the study, 97.3% of patients in the Dalvance single-dose arm demonstrated an early clinical response, and 93.6% had an early clinical response in the two-dose arm, while 86.7% did in the comparator arm. The safety data in the children was similar to what was seen in adults. The drug is a second-generation, semi-synthetic lipoglycopeptide. It is made up of a lipophilic side-chain attached to an enhanced glycopeptide backbone. Dalvance is approved for adults with ABSSSI caused by susceptible Gram-positive bacterium, such as Staphylococcus aureus, including MRSA, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group, and Enterococcus faecalis. It was first approved for adults with skin infections in May 2014. At that time it was developed by Durata Therapeutics. Durata was acquired by Actavis in 2014 for $675 million. Actavis acquired Allergan in 2015 and changed the company name to Allergan. AbbVie completed its acquisition of Allergan in May 2020 in a deal worth about $63 billion.

Acquisition

100 Deals associated with Dalbavancin Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
-	Dalbavancin Hydrochloride	J01XA04	DB06219

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Skin and skin structure infections	US	AbbVie, Inc.	23 May 2014

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Bacteremia	Phase 3	FR	Advanz Pharma Corp. Ltd.	23 Jun 2023
Catheter-Related Infections	Phase 3	FR	Advanz Pharma Corp. Ltd.	23 Jun 2023
Staphylococcus Aureus Infections	Phase 3	FR	Advanz Pharma Corp. Ltd.	23 Jun 2023
MRSA - Methicillin resistant Staphylococcus aureus infection	Phase 3	US	AbbVie, Inc.	30 Mar 2017
MRSA - Methicillin resistant Staphylococcus aureus infection	Phase 3	AR	AbbVie, Inc.	30 Mar 2017
MRSA - Methicillin resistant Staphylococcus aureus infection	Phase 3	BY	AbbVie, Inc.	30 Mar 2017
MRSA - Methicillin resistant Staphylococcus aureus infection	Phase 3	BR	AbbVie, Inc.	30 Mar 2017
MRSA - Methicillin resistant Staphylococcus aureus infection	Phase 3	BG	AbbVie, Inc.	30 Mar 2017
MRSA - Methicillin resistant Staphylococcus aureus infection	Phase 3	CL	AbbVie, Inc.	30 Mar 2017
MRSA - Methicillin resistant Staphylococcus aureus infection	Phase 3	CO	AbbVie, Inc.	30 Mar 2017

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04775953 (CTgov)	Phase 2	Staphylococcus aureus bacteraemia	200	Dalbavancin (Dalbavancin)	epsbxxofcg(mgoxvihesa): Pr(Better DOOR in dalbavancin arm) = 47.70 (95% CI, 39.84 - 55.68) View more	-	22 Oct 2024
				cefazolin+penicillin+oxacillin+Nafcillin+daptomycin+Vancomycin (Standard of Care)
NCT04959799 (DALBADIA, Pubmed \| J Glob Antimicrob Resist)	Not Applicable	Diabetes Mellitus \| Infectious Diseases First line Gram-positive bacterial infection \| Enterococcus faecalis	97	Dalbavancin	nctxwwpqth(kimwwucajw) = ytmwxoshuf goitmscivp (kseoommxiz ) View more	Positive	01 Mar 2024
NCT03372941 (CTgov)	Phase 4	Skin and skin structure infections \| Skin Diseases, Infectious	11	Dalbavancin (Alternative Treatment Strategy)	qffnkwtikk(wkeciwonae) = mzswoyonhz bizyvktoly (xoznjdnihd, dlspffmdjj - cxruhklhne) View more	-	09 Dec 2022
				vancomycin (Usual Care)	qffnkwtikk(wkeciwonae) = vjajqplwuq bizyvktoly (xoznjdnihd, ufdhfxgzdh - rkrkdsbwyv) View more
NCT02961764 (Pubmed \| Acad Emerg Med)	Phase 4	Skin Diseases, Infectious	313	Long-Acting Intravenous Antibiotic (Usual care)	vfubhqdmib(qissvfqblm) = aiquydgxsz uydbgwtgjf (yzxvmorxhh ) View more	Positive	29 Mar 2021
				Long-Acting Intravenous Antibiotic (Clinical pathway)	vfubhqdmib(qissvfqblm) = zjfwegwryv uydbgwtgjf (yzxvmorxhh ) View more
NCT02940730 (CTgov)	Phase 4	Infectious peritonitis	10	Dalbavancin via Intravenous Administration (Dalbavancin Via IV)	umokyvcfis(kkhijhugum) = cjvpoukksp jvhupjomnu (njeqamodsq, srwmcsxacg - qzabhschvi) View more	-	19 Mar 2021
				Dalbavancin via Intraperitoneal Administration (Dalbavancin Via IP)	umokyvcfis(kkhijhugum) = sppmgfdvmr jvhupjomnu (njeqamodsq, fyodohhcnh - kuuvsqwbuj) View more
NCT02961764 (CTgov)	Phase 4	Skin and skin structure infections	313	Usual Care (Usual Care)	sdfjxunzki(ridgmakfle): Odds Ratio (OR) = 0.289 (95% CI, 0.156 - 0.532), P-Value = <0.001 View more	-	10 Apr 2020
				Dalbavancin (New Critical Pathway)
NCT03233438 (ENHANCE ABSSSI, Pubmed \| Infect Dis Ther)	Phase 4	Skin and skin structure infections	91	Dalbavancin	zlfugtvabd(uasmhkprsi) = 17% (n = 7) were found to have possible causal relation to dalbavancin in the post-period vosjpuftlf (vmymvhbcmf ) View more	-	01 Mar 2020
				Dalbavancin (Usual care)
NCT03233438 (ENHANCE ABSSSI, CTgov)	Phase 4	Bacterial Infections \| Skin and skin structure infections	91	Usual Care (Usual Care)	qbjfymwqvl(tbxfsrafab) = tbdehnexhq ulmpcqvsys (qjyxfgchyn, qliwytlqdx - ktjbodxbxs) View more	-	18 Jan 2020
				Dalbavancin (New Critical Pathway)	qbjfymwqvl(tbxfsrafab) = rrgjzmnvzz ulmpcqvsys (qjyxfgchyn, ywkejfzbxr - ipgzmwesfd) View more
NCT02685033 (CTgov)	Phase 2	Osteomyelitis	80	Dalbavancin (Dalbavancin)	minqnoyoyf(oeylbzjlzq) = atwycekdfd meakexhafw (orgdhtrntv, rjohpykgac - zfxqqlbihq) View more	-	04 Jan 2019
				Comparator (Standard of Care)	minqnoyoyf(oeylbzjlzq) = tvuxpglmik meakexhafw (orgdhtrntv, occephhxlz - okmkvuquxp) View more
NCT02685033 (Pubmed \| Open Forum Infect Dis) Manual	Phase 2	Osteomyelitis	80	Dalbavancin	qefxlmavrv(hoomtgqpvx) = htydqhporl ldrmcwjhcd (byiugxvhym ) View more	Positive	10 Dec 2018
				SOC	qefxlmavrv(hoomtgqpvx) = gxzmexyrhe ldrmcwjhcd (byiugxvhym )

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis