Comparative Clinical Evaluation of the Effectiveness of a Novel Local Drug Delivery Agent Containing Tetracycline HCL Micro-particles vs Tetracyline HCL fibers (Periodontal AB plusTM) in Treatment of Periodontal Pockets in Patients with Chronic Periodontitis - Nil

Start Date11 Jun 2024

Sponsor / Collaborator-

NCT06351891 / Not yet recruitingPhase 4IIT

Efficacy and Safety of Bismuth Quadruple Therapy Containing Cefuroxime and Tetracycline as First-line Therapy for Eradicating Helicobacter Pylori in Patients Allergic to Penicillin: A Multicenter, Randomized Controlled Study

The researchers collected untreated H. pylori positive patients from outpatient clinics. Subjects were randomly assigned to receive either 14 days of bismuth quadruple therapy with cefuroxime and tetracycline or 14 days of bismuth quadruple therapy with cefuroxime and levofloxacin for Helicobacter pylori eradication. After 6 weeks of treatment, subjects underwent another 13C urea breath test. Eradication rates, adverse reaction rates and patient compliance were calculated.

Start Date01 Apr 2024

Sponsor / Collaborator

Qilu Hospital of Shandong University

NCT06299605 / Not yet recruitingNot ApplicableIIT

Triple Versus Quadruple Therapy With Amoxicillin and Tetracycline for the Eradication of Helicobacter Pylori: A Multicenter Randomized Controlled Trial

The study aimed to compare the efficacy and safety of 7-day and 14-day vonoprazan-amoxicillin-tetracycline triple therapy with 14-day vonoprazan-amoxicillin-tetracycline-bismuth quadruple therapy for the eradication of Helicobacter pylori. Subjects were randomized to receive the intervention and were reviewed by 13C-urea breath test after 6 weeks. The eradication rates, adverse reaction rates and patient adherence were calculated.

Start Date01 Mar 2024

Sponsor / Collaborator

Shandong University

[+1]

100 Clinical Results associated with Tetracycline Hydrochloride/Epidihydrocholesterin

100 Translational Medicine associated with Tetracycline Hydrochloride/Epidihydrocholesterin

100 Patents (Medical) associated with Tetracycline Hydrochloride/Epidihydrocholesterin

32,200

Literatures (Medical) associated with Tetracycline Hydrochloride/Epidihydrocholesterin

01 Dec 2024·Molecular biology reports

Understanding the bacterial community structure associated with the Eichhornia crassipes rootzone

Article

Author: Singh, Dileep Kumar ; Sodhi, Kushneet Kaur ; Singh, Chandra Kant

BACKGROUND:

Plant microbiome acts as an interface between plants and their environment, aiding in the functioning of the ecosystem, such as protection against abiotic and biotic stress along with improving nutrient uptake. The rhizosphere is an essential interface for the interaction between plants and microbes and plays a substantial part in the removal as well as uptake of heavy metals and antibiotics from contaminated locations. Eichhornia crassipes is a promising plant that contains a rich community of microbes in its rhizosphere. Microorganism's association with plants embodies a crucial pathway via which humans can also be exposed to antibiotic-resistant genes and bacteria.

METHODS AND RESULTS:

In our earlier study enhanced removal of ciprofloxacin was observed by plant growth-promoting Microbacterium sp. WHC1 in the presence of E. crassipes root exudates. Therefore, the V3-V4, hypervariable region of the 16 S rRNA gene was studied to assess the bacterial diversity and functional profiles of the microbiota associated with plant roots. Using the QIIME software program, 16 S rRNA data from the Next Generation Sequencing (NGS) platform was examined. Alpha diversity including Chao1, Observed Shannon, and Simpson index denote significantly higher bacterial diversity. Proteobacteria (79%) was the most abundant phylum which was present in the root samples followed by Firmicutes (8%) and Cyanobacteria (8%). Sulfuricurvum (36%) is the most abundant genus belonging to the family Helicobacteraceae and the species kujiense in the genus Sulfuricurvum is the most abundant species present in the root sample. Also, the bacterial communities in the rhizoplane of Eichhornia crassipes harbor the genes conferring resistance to beta-lactams, tetracycline, fluoroquinolones, and penams.

CONCLUSION:

Metagenomic studies on the E. crassipes microbiome showed that the bacterial communities constituting the root exudates of the Eichhornia aid them to survive in a polluted environment.

01 Dec 2024·Applied microbiology and biotechnology

Adaptive evolution of Salmonella Typhimurium LT2 exposed to carvacrol lacks a uniform pattern

Article

Author: Gayan, Elisa ; García-Gonzalo, Diego ; Campillo, Raul ; Pagan, Rafael ; Merino, Natalia ; Pagan, Elisa ; Berdejo, Daniel

Abstract:

Emergence of genetic variants with increased resistance/tolerance to natural antimicrobials, such as essential oils, has been previously evidenced; however, it is unknown whether mutagenesis follows a general or a specific pattern. For this purpose, we carried out four adaptive laboratory evolutions (ALE) in parallel of Salmonella enterica Typhimurium with carvacrol. After 10 evolution steps, we selected and characterized one colony from each lineage (SeCarA, SeCarB, SeCarC, and SeCarD). Phenotypic characterization of the four evolved strains revealed enhanced survival to lethal treatments; two of them (SeCarA and SeCarB) showed an increase of minimum inhibitory concentration of carvacrol and a better growth fitness in the presence of carvacrol compared to wild-type strain. Whole genome sequencing revealed 10 mutations, of which four (rrsH, sseG, wbaV, and flhA) were present in more than one strain, whereas six (nirC, fliH, lon, rob, upstream yfhP, and upstream argR) were unique to individual strains. Single-mutation genetic constructs in SeWT confirmed lon and rob as responsible for the increased resistance to carvacrol as well as to antibiotics (ampicillin, ciprofloxacin, chloramphenicol, nalidixic acid, rifampicin, tetracycline, and trimethoprim). wbaV played an important role in increased tolerance against carvacrol and chloramphenicol, and flhA in cross-tolerance to heat treatments. As a conclusion, no common phenotypical or genotypical pattern was observed in the isolated resistant variants of Salmonella Typhimurium emerged under carvacrol stress. Furthermore, the demonstration of cross-resistance against heat and antibiotics exhibited by resistant variants raises concerns regarding food safety.

Key points:

• Stable resistant variants of Salmonella Typhimurium emerged under carvacrol stress• No common pattern of mutagenesis after cyclic exposures to carvacrol was observed• Resistant variants to carvacrol showed cross-resistance to heat and to antibiotics

Graphical abstract:

01 Dec 2024·Molecular biology reports

Detection of phylogrouping, adhesin, and extended spectrum β-lactamases genes in hospital acquired uropathogenic Escherichia coli isolates

Article

Author: El Azawy, Doaa Sh ; El-Sayed, Hend Abdalla ; Fahmy, Yasmin Ahmed ; Orabi, Eman Elshahat ; Hussein, Samia ; Attia, Osama ; El Maghraby, Hanaa M

BACKGROUND:

It has been interesting to compare the levels of antimicrobial resistance and the virulence characteristics of uropathogenic Escherichia coli (UPEC) strains of certain phylogenetic groups. The purpose of this study was to identify the frequency of phylogenetic groups, adhesin genes, antibiotic sensitivity patterns, and extended spectrum-lactamases (ESBLs) genes in hospital-acquired UPEC.

METHODS:

After UPEC isolation, the disc diffusion method was used to assess its susceptibility to antibiotics. Combination disc testing confirmed the existence of ESBL producers. Polymerase chain reaction (PCR) was used to detect genes for adhesin and ESBLs.

RESULTS:

One hundred and twenty-eight E. coli were isolated which had the highest resistance to tetracycline (96%) followed by cefoxitin (93%), cefepime (92%), ceftazidime (79%), aztreonam (77%) and sulfamethoxazole -trimethoprim (75%). About 57% of isolates were phenotypically ESBLs positive and they were confirmed by PCR. B2 phylogroup (41%) was the most frequent in E. coli isolates then group D (30%), group A (18%), and lastly group B1 (11%). ESBLs genes were more significantly prevalent in phylogroups B2 and D than other phylogroups (P < 0.001). Regarding adhesin genes, both fim H and afa were more significantly associated with group B2 than other groups (P < 0.009, < 0.032), respectively. In ESBL-positive isolates, both genes were more significantly detected compared to negative ones (P < 0.001).

CONCLUSION:

Phylogroups B2 and D of UPEC are important reservoirs of antimicrobial resistance and adhesion genes. Detection of ESBL-producing E. coli is important for appropriate treatment as well as for effective infection control in hospitals.

News (Medical) associated with Tetracycline Hydrochloride/Epidihydrocholesterin

18 Apr 2024

·www.biospace.com

Paratek Pharmaceuticals Presenting New Data from NUZYRA® (Omadacycline) and Investigator-Initiated Pre-Clinical Studies at European Society of Clinical Microbiology & Infectious Diseases Global (ESCMID Global) 2024

BOSTON, April 18, 2024 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc., a biopharmaceutical company focused on providing innovative medical therapies that create positive patient stories in the hospital, community and public health settings, today announced that three new pre-clinical studies with NUZYRA® (omadacycline) will be presented at European Society of Clinical Microbiology & Infectious Diseases Global (ESCMID Global, formerly ECCMID). The hybrid conference will be held April 27-30 at the Fira Gran Via in Barcelona, Spain. View the ESCMID scientific program. “Paratek continues to invest in science to further our understanding of NUZYRA, as well as explore its future utility in addressing additional unmet patient needs,” said Randy Brenner, chief development and regulatory officer of Paratek. “Next week’s ESCMID presentations include a study assessing the potential immunomodulating properties of NUZYRA in addition to its antibacterial activity. Two additional studies expand upon our understanding of NUZYRA for Mycobacterium abscessus and Mycobacterium avium complex (MAC).” NUZYRA presentation details Presentation Title: Immunomodulatory activity of omadacycline in vitro and in a murine model of acute lung injury (ALI) (Investigator-initiated research) Time/Location: April 27, noon CEST (7:00 a.m. U.S. EST) in poster area Abstract #: 04151 Presenter: Paul Beringer, PharmD., Professor of Clinical Pharmacy, University of Southern California Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences, Los Angeles, CA Session title: 10g – Immune response to infection (including in vitro, animal and human studies, laboratory assessment of immunity and response, excl sepsis biomarkers) Poster session: P3884 Presentation Title: Omadacycline alone and in combination as a treatment option for Mycobacterium avium infections Time/Location: April 28, noon CEST (7:00 a.m. U.S. EST) in poster area Abstract #: 00304 Presenter: Saskia E. Mudde, Erasmus University Medical Center, Department of Medical Microbiology and Infectious Diseases, Rotterdam, Netherlands Session title: 2a – Tuberculosis and other mycobacterial infections (including epidemiology, clinical, diagnostics, antimycobacterial drugs, susceptibility testing, treatment & prevention) Poster session: P0609 Presentation Title: Minimum inhibitory concentrations (MICs) of tigecycline correlate strongly with those of omadacycline Time/Location: April 29, noon CEST (7:00 a.m. U.S. EST) in poster area Abstract #: 01492 Presenter: Vinicius Calado Nogueira de Moura, Division of Mycobacterial and Respiratory Infections, Department of Medicine, National Jewish Health, Denver, CO Session title: 3c – Susceptibility testing methods (including assay validation, phenotypic assays and comparative studies, excluding TB) Poster session: P1563 About Paratek Pharmaceuticals, Inc. Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on providing innovative medical therapies that create positive patient stories in the hospital, community and public health settings. The company's lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the United States for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). Paratek has a collaboration agreement with Zai Lab Limited for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights. Zai Lab received approval of both IV and oral NUZYRA as a Category 1 innovative drug by the National Medical Products Administration of China for the treatment of CABP and ABSSSI in December 2021. Paratek is also conducting a Phase 2b study with NUZYRA in a rare disease, non-tuberculous mycobacterial (NTM) pulmonary disease, caused by Mycobacterium abscessus complex. In December 2019, BARDA awarded Paratek a contract that is now valued at up to approximately $304 million. In addition to supporting the development of NUZYRA for both the treatment and prophylaxis of pulmonary anthrax, this contract supports the U.S. onshoring of NUZYRA and manufacturing security requirements; FDA post-marketing requirements associated with the initial NUZYRA approval; and the procurement of up to 10,000 treatment courses of NUZYRA for the treatment of anthrax. For more information, visit or follow us on LinkedIn and Twitter. About NUZYRA® NUZYRA® (omadacycline) is a novel antibiotic with both once-daily oral and intravenous (IV) formulations for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). A modernized tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals and other drug-resistant strains. MEDIA CONTACT: Christine Fanelle Scient PR Christine@ScientPR.com 215-595-5211

Drug ApprovalPhase 2License out/in

27 Mar 2024

·www.pharmaceutical-technology.com

Juvisé licenses J&J’s MS drug Ponvory for marketing outside North America

Ponvory is a once-daily oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator that has been approved for treating relapsing forms of MS. Image Credit: Tero Vesalainen / Shutterstock. France-based Juvisé Pharmaceuticals has acquired global marketing rights, excluding the US and Canada, for Johnson & Johnson (J&J)’s multiple sclerosis (MS) therapy Ponvory (ponesimod). The French company will also assume worldwide manufacturing duties for Ponvory from sites based in France and Switzerland. Juvisé secured the Ponvory rights from J&J’s subsidiary Actelion Pharmaceuticals . The financial details of the deals were not disclosed, with Juvisé adding that the deal was funded by “a mix of capital increase, additional debt, and shareholder loan”. Furthermore, a European private credit manager, Bpifrance and Pemberton Asset Management, acquired a minority stake in Juvisé to fund Ponvory’s acquisition. Ponvory is a once-daily oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator. The drug was the first oral disease-modifying treatment (DMT) to demonstrate superior efficacy compared to Sanofi ’s Aubagio (teriflunomide), another first-line therapy for MS. Ponvory has been approved by multiple regulatory bodies , including the European Medicines Agency (EMA) as a first-line treatment for adults with relapsing forms of MS. In December 2023, J&J sold the North American marketing rights for Ponvory to Vanda Pharmaceuticals for $100m. See Also: J&J’s nipocalimab gains FDA fast track status for FNAIT risk reduction Experts flag concerns with drug compliance in osteoporosis landscape Juvisé expects Ponvory to generate significant sales this year. The company forecast its revenues to reach €180m ($194m), up by approximately 38% compared to 2023. Ponvory’s sales are expected to account for about 24% of the total profits. The MS market is expected to generate $41.1bn in sales across 68 global markets by 2030, as per a GlobalData market analysis report . The European market for MS therapies is expected to be worth $8.8m in the same period. Roche’s Ocrevus (ocrelizumab) and Novartis ’ Kesimpta (ofatumumab) are expected to be market leaders in the space, bringing in sales of $6.3bn and $4.5bn in 2030, respectively. GlobalData is the parent company of Pharmaceutical Technology . Juvisé has previously acquired marketing rights to multiple therapies from top pharmaceutical companies such as Novartis, AstraZeneca , and AbbVie . In 2022, the company acquired global rights for the combination antibiotic Pylera (bismuth subcitrate potassium, metronidazole, and tetracycline) from AbbVie. In 2019, Juvisé bought the global rights for two cancer therapies , Arimidex (anastrozole) and Casodex (bicalutamide), from AstraZeneca for an upfront payment of $181m.

Drug ApprovalAcquisitionFast TrackLicense out/in

05 Mar 2024

·www.globenewswire.com

Paratek Pharmaceuticals Announces Positive Efficacy Data for NUZYRA® as Post-Exposure Prophylaxis of Inhalational Anthrax, Triggering Additional Procurement under BARDA Project BioShield Contract

Oral NUZYRA Tablets Procured by BARDA were Manufactured in the United States as Part of the Company’s Onshoring InitiativeBOSTON, March 05, 2024 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc., a biopharmaceutical company focused on providing innovative medical therapies that create positive patient stories in the hospital, community and public health settings, today announced positive top-line efficacy data for NUZYRA® (omadacycline) as post-exposure prophylaxis (PEP) in a non-human primate (NHP) model of inhalational anthrax. Anthrax (B. anthracis) is an infectious disease caused by gram-positive, rod-shaped, spore-forming bacteria that can lead to severe illness and death. In the study, a 100% survival rate was observed in omadacycline-treated NHPs at the end of the treatment period (30 days) and a survival rate over 90% was observed over the entirety of the 60-day observation period. All NHPs treated with placebo died due to anthrax within 10 days of exposure to B. anthracis. Top-line data from this study triggered an additional procurement of NUZYRA under the company’s Project BioShield contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services. Oral NUZYRA tablets associated with this procurement were manufactured in the United States as part of the company’s U.S. onshoring efforts. “Positive top-line data from this study represents continued progress in our anthrax development program and further validates NUZYRA’s potential to effectively treat pulmonary anthrax,” said Randy Brenner, Paratek’s chief development and regulatory officer. “This procurement also represents a significant milestone in the company’s onshoring efforts as for the first time Paratek is providing BARDA with NUZYRA tablets produced on U.S. soil. We are grateful for BARDA’s continued commitment in our partnership to address national security threats and public health emergencies involving anthrax, and believe that these efforts further strengthen our nation’s commitment to address potential bioterrorism threats at a time when antibiotic resistance is a global concern.” A meeting with FDA will be planned for the middle of 2024 to align on the final studies required to support the sNDA submission for both anthrax treatment and PEP indications. In December 2019, BARDA awarded Paratek a contract (75A50120C00001) that is now valued at up to approximately $304 million. In addition to supporting the development of NUZYRA for both the treatment and prophylaxis of pulmonary anthrax, this contract supports the U.S. onshoring of NUZYRA and manufacturing security requirements; FDA post-marketing requirements associated with the initial NUZYRA approval; and the procurement of up to 10,000 treatment courses of NUZYRA for the treatment of anthrax. About Paratek Pharmaceuticals, Inc.Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on providing innovative medical therapies that create positive patient stories in the hospital, community and public health settings. The company’s lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the United States for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights. Paratek is also conducting a Phase 2b study with NUZYRA in a rare disease, non-tuberculous mycobacterial (NTM) pulmonary disease, caused by Mycobacterium abscessus complex. Paratek estimates this opportunity represents a potential $1 billion addressable market in the United States. Paratek exclusively licensed U.S. rights and rights to the greater China territory for Seysara® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC. Paratek retains the development and commercialization rights for sarecycline in the rest of the world. For more information, visit www.ParatekPharma.com or follow us on LinkedIn and X. About NUZYRA®NUZYRA® (omadacycline) is a novel antibiotic with both once-daily oral and intravenous (IV) formulations for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). A modernized tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals and other drug-resistant strains. MEDIA CONTACT:Christine FanelleScient PRChristine@ScientPR.com215-595-5211

License out/inPhase 2Clinical ResultDrug Approval

100 Deals associated with Tetracycline Hydrochloride/Epidihydrocholesterin

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Indication	Country/Location	Organization	Date
Periodontitis	JP	Nippon Shika Yakuhin Co. Ltd.	30 Sep 2004
Secondary infection	JP	Nippon Shika Yakuhin Co. Ltd.	30 Sep 2004
Stomatitis	JP	Nippon Shika Yakuhin Co. Ltd.	30 Sep 2004
Gingivitis	JP	Nippon Shika Yakuhin Co. Ltd.	06 Nov 1984

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ARVO2022	Not Applicable	Pterygium	-	Low dose oral tetracycline	wzrgtuvmfw(hxlstnzmwn) = mxkhusprpw svkbmcsyye (xzjmkiffzr )	-	01 Jun 2022
JPRN-UMIN000018318 (ASCO2018)	Not Applicable	Mouth Neoplasms	-	Topical tetracycline ointment	pdvasvqlli(lfnvzmwklc) = olmijficqc mvfgecenwq (ggterxdhjt )	Positive	01 Jun 2018
NCT00347776 (CTgov)	Phase 4	Trichiasis	1,452	topical tetracycline	nfubflujot(zrttcbwwme) = rvuycudins pdokiksoea (lclcdgplwm, ynadvixndv - yjjhygocxx) View more	-	07 Aug 2017
NCT01880515 (CTgov)	Phase 2	Non-Small Cell Lung Cancer \| Exanthema	107	Tetracycline (Tetracycline)	pyccjrptny(thxegstjus) = ojpegvovtu ovvegskzbw (ifdldlcjav, wdviqqiygt - uydmytzbbz) View more	-	12 Apr 2017
				tetracycline (No Tetracycline)	pyccjrptny(thxegstjus) = kriyppzfjd ovvegskzbw (ifdldlcjav, wzbiyozzjg - tdpbisycgy) View more
NCT02159976 (not provided, Pubmed \| BMC Gastroenterol)	Not Applicable	Helicobacter pylori infection First line	390	10-day sequential therapy	byxyxjxdwy(enzluwyixk) = omrisnjsod ewcfhmfvbk (hfxnvucudv ) View more	-	26 Jul 2016
				14-day modified bismuth quadruple therapy	byxyxjxdwy(enzluwyixk) = cnvtfpkmno ewcfhmfvbk (hfxnvucudv ) View more
NCT01753856 (CTgov)	Phase 4	Osteoporosis	69	Demeclocycline+Vitamin D+Teriparatide+Tetracycline (Teriparatide)	gldkgjhupk(ulijcoyctw) = cuelfocfqz ijwlpcjdry (zyypjxxtim, cywvifhprq - bldjscrhzg) View more	-	08 Oct 2015
				Demeclocycline+Vitamin D+Tetracycline (Denosumab)	gldkgjhupk(ulijcoyctw) = dofqyasjlc ijwlpcjdry (zyypjxxtim, zhqdizwhik - efdxjwwxtd) View more
NCT01880515 (Pubmed \| Lung Cancer)	Phase 2	Non-Small Cell Lung Cancer	90	Pre-emptive tetracycline	fnzofdrogw(numooxusif) = airmpxrblg lrmcifkuvl (gorhvjdmhv ) View more	Positive	01 Jun 2015
N03CB (ASCO2007)	Phase 3	Drug Eruptions	61	Tetracycline 500 mg	ynhlgmpsro(rhcwbiwctw) = aohmqjxkqc efusutuxwj (elhwyahnnl )	-	20 Jun 2007
				Placebo	ynhlgmpsro(rhcwbiwctw) = acpmacemgg efusutuxwj (elhwyahnnl )
NCT05432115 \| NCT05802888 (Pubmed \| Eur J Gastroenterol Hepatol)	Phase 4	Helicobacter pylori infection	136	Ranitidine-bismuth citrate, tetracycline, and metronidazole	uyesqyusqs(bvpsejefvn) = nxyzghqgkm yinxkvznub (gmiltlvpvj, 72 - 86)	-	01 Oct 2004
				Proton pump inhibitor-based triple therapy	uyesqyusqs(bvpsejefvn) = hzrsyvtwik yinxkvznub (gmiltlvpvj, 78 - 91)

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