A Phase 1, Single-center, Open-label, Non-randomized, Fixed-sequence, Drug-drug Interaction Study to Assess the Effect of Repeated Doses of Intravenous Ceftobiprole on the Pharmacokinetics of Oral Pitavastatin (OATP1B Substrate) and on Plasma Levels of Coproporphyrin I (OATP1B Biomarker) in Healthy Subjects

The goal of this clinical study is to determine the effect of the test drug ceftobiprole (a drug approved for the treatment of bacterial infections) on the elimination of pitavastatin (a drug approved for the treatment of increased levels of cholesterol in blood) from the body. This interaction will be investigated by pharmacokinetic (PK) assessments.
The PK of pitavastatin will be assessed when administered alone and when administered together with ceftobiprole in a study design including two treatment periods.
The clinical study will also investigate the safety of ceftobiprole and how well ceftobiprole is tolerated by healthy subjects when it is administered in combination with pitavastatin. In addition, the effect of ceftobiprole on a specific marker, called coproporphyrin I, will be assessed in the blood.
The duration of the study will be a maximum of 38 days.

Start Date17 Jan 2025

Sponsor / Collaborator

Basilea Pharmaceutica AG

[+1]

ChiCTR2500096047

/ RecruitingEarly Phase 1IIT

Pharmacokinetic Characteristics and Blood-Brain Barrier Penetration of Ceftobiprole in Patients with Proposed or Confirmed Central Nervous System Infection

Start Date28 Oct 2024

Sponsor / Collaborator-

100 Clinical Results associated with Ceftobiprole Medocaril Sodium

100 Translational Medicine associated with Ceftobiprole Medocaril Sodium

100 Patents (Medical) associated with Ceftobiprole Medocaril Sodium

463

Literatures (Medical) associated with Ceftobiprole Medocaril Sodium

01 Aug 2025·DIAGNOSTIC MICROBIOLOGY AND INFECTIOUS DISEASE

In Vitro activity of ceftobiprole against 20,255 recent clinical bacterial isolates in Canada (CANWARD 2015-2023)

Article

Author: Adam, Heather J ; Walkty, Andrew ; Baxter, Melanie ; Gemme, Élodie ; Karlowsky, James A ; Weiss, Karl ; Zhanel, George G ; Lagacé-Wiens, Philippe

BACKGROUND:

Ceftobiprole is a fifth-generation cephalosporin active against methicillin-resistant Staphylococcus aureus (MRSA). In this study, we determined the in vitro activities of ceftobiprole and comparator agents against 20,225 common Gram-positive and Gram-negative bacteria isolated from patients who presented for care at 16 tertiary-care hospitals across Canada between 2015 and 2023.

METHODS:

Minimum inhibitory concentrations (MICs) were determined using the Clinical and Laboratory Standards Institute (CLSI) reference M07 broth microdilution method. MICs were interpreted using CLSI M100 breakpoints where available. As CLSI does not publish MIC breakpoints for ceftobiprole, ceftobiprole MICs were interpreted using United States Food and Drug Administration (FDA), European Committee on Antimicrobial Susceptibility Testing (EUCAST), and Health Canada breakpoints.

RESULTS:

Ceftobiprole inhibited 100 % of MRSA at ≤ 4 μg/ml; 100 % of methicillin-susceptible S. aureus (MSSA) and 99.8% of MRSA at ≤ 2 μg/ml; 100 % of Streptococcus pneumoniae and Streptococcus pyogenes at ≤ 0.5 μg/ml; and 97.9 % of ESBL-negative Escherichia coli, 97.4 % of ESBL-negative Klebsiella pneumoniae, 97.8 % of Proteus mirabilis, 89.3 % of Serratia marcescens, 78.2 % of Enterobacter cloacae, 55.7 % of Klebsiella oxytoca at ≤ 0.25 μg/ml. Ceftobiprole was inactive against ESBL-positive E. coli and ESBL-positive K. pneumoniae.

CONCLUSIONS:

Ceftobiprole demonstrated potent in vitro activity against MRSA, MSSA, S. pneumoniae, S. pyogenes, ESBL-negative E. coli and K. pneumoniae, and P. mirabilis isolated from clinical specimens of patients seeking care at Canadian tertiary-care hospitals.

01 Jul 2025·ANNALS OF PHARMACOTHERAPY

Ceftobiprole Medocaril: A New Fifth-Generation Cephalosporin

Review

Author: Zimmerman, Justin ; Kale-Pradhan, Pramodini B. ; Giuliano, Christopher

Objective::

The objective was to review the pharmacology, efficacy, and safety of intravenous ceftobiprole in the treatment of bloodstream infections, acute bacterial skin and skin structure infections (ABSSSIs), community-acquired pneumonia (CAP), and hospital-acquired pneumonia (HAP), or ventilator-associated pneumonia (VAP).

Data Sources::

PubMed and ClinicalTrials.gov were searched using the following terms: ceftobiprole, ceftobiprole medocaril, ceftobiprole medocaril sodium, Zevtera, and BAL5788.

Study Selection and Data Extraction::

Articles published in English between January 1985 and August 15, 2024, related to pharmacology, safety, efficacy, and clinical trials were reviewed.

Data Synthesis::

Ceftobiprole has shown similar efficacy to comparator antibiotics in CAP, ABSSSIs, and bloodstream infections. Overall treatment success in patients with bacteremia was 69.8% and 68.7%; 91.3% and 88.1% with ABSSSIs and 86.6% and 87.4% with CAP in ceftobiprole and comparator groups, respectively. Finally, in the management of HAP and VAP, ceftobiprole was inferior in the VAP population. Ceftobiprole had a favorable safety profile with gastrointestinal adverse effects occurring more frequently than comparators.

Relevance to Patient Care and Clinical Practice in Comparison to Existing Drugs::

Clinicians have limited options to treat multidrug-resistant infections. Ceftobiprole has demonstrated efficacy against causative pathogens in specific infections including methicillin-resistant Staphylococcus aureus bacteremia (SAB), ABSSSI, and CAP and may be considered a viable alternative. However, ceftobiprole’s impact on HAP, VAP, and febrile neutropenia needs to be further delineated.

Conclusion::

Ceftobiprole’s broad-spectrum activity makes it a viable option for treating patients hospitalized with CAP, ABSSSI, and SAB. Further studies are needed in severely ill HAP or VAP, febrile neutropenia, and pediatric patients.

01 Jul 2025·Microbial Drug Resistance

In Vitro Activity of Novel Antibiotics Against Corynebacterium spp. Clinical Isolates Responsible for Difficult-to-Treat Infections.

Article

Author: Cattoir, Vincent ; Collet, Anaïs ; Penven, Malo ; Piau, Caroline ; Guérin, François ; Bichali, Ahmad Rami ; Lecourt, Maxime ; Reissier, Sophie

Corynebacterium species can be responsible for difficult-to-treat (DTT) infections, for which novel therapeutic options may be used. This study assessed the in vitro activity of newer antibiotics against Corynebacterium clinical isolates responsible for DTT infections between 2021 and 2023 in our center. Minimum inhibitory concentrations (MICs) were determined by the broth microdilution method or the gradient diffusion method. Interpretation was done according to the 2024 Comité de l'Antibiogramme de la Société Française de Microbiologie breakpoints. In total, 116 isolates were collected, including 73 (66%) responsible for bone and joint infections, among which half were device related. C. striatum was the most frequently isolated species. The activity of ceftaroline (MIC₉₀ >2 mg/L), ceftobiprole (MIC₉₀ >8 mg/L), and delafloxacin (MIC₉₀ >1 mg/L) was limited. By contrast, other molecules tested showed higher activity with low MIC₉₀ values: linezolid (MIC₉₀ ≤0.5 mg/L), tedizolid (MIC₉₀ = 0.12 mg/L), dalbavancin (MIC₉₀ = 0.12 mg/L), tigecycline (MIC₉₀ = 0.12 mg/L), eravacycline (MIC₉₀ = 0.06 mg/L), and omadacycline (MIC₉₀ = 0.5 mg/L). One C. striatum strain exhibited a high level of daptomycin resistance after antibiotic exposure (MIC >16 mg/L). The in vitro activity of most of these novel antibiotics is excellent against Corynebacterium clinical isolates. They could represent a real alternative for treating DTT infections due to Corynebacterium spp.

112

News (Medical) associated with Ceftobiprole Medocaril Sodium

11 Jul 2025

·www.globenewswire.com

Basilea receives USD 39 million funding under BARDA agreement to continue to advance novel antifungals fosmanogepix and BAL2062

July 08, 2025 Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today that the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services, committed the next USD 39 million to Basilea to continue to advance the development of Basilea’s novel antifungals fosmanogepix and BAL2062. This additional funding is based on the successful completion of a milestone within the “Other Transaction Agreement” (OTA, agreement number 75A50124C00033) that was awarded on September 30, 2024, and which allows for potential funding of up to approximately USD 268 million in total to develop antifungal and antibacterial assets. David Veitch, Chief Executive Officer of Basilea, said: “We are very pleased to receive the continued funding under the OTA with BARDA to support the development of our antifungal drug candidates fosmanogepix and BAL2062. Both compounds offer a novel mechanism of action and represent new therapeutic options for patients with aspergillosis, candidiasis or other life-threatening fungal infections. These infections primarily affect patients with weakened immune systems, such as cancer or transplant patients. Infections with difficult-to-treat rare molds or with resistance to current therapies are increasing. Hence, there continues to be a high medical need for new innovative antifungals.” He added: “This second tranche of funding within the BARDA OTA will support the ongoing phase 3 study with fosmanogepix in yeast infections and the second phase 3 study, in mold infections, which is expected to start soon. It also provides funding for the preparation for the start of the phase 2 study for our antifungal BAL2062.” The USD 39 million is in addition to the initial USD 29 million BARDA committed at the signing of the OTA in September 2024. BARDA’s financial contribution is about 60% of the total costs of the supported projects over the term of the OTA, which could provide a total potential non-dilutive funding of up to approximately USD 268 million, over up to 12 years, if all additional options to extend the contract are exercised by BARDA, upon successful completion of pre-defined milestones, including clinical and regulatory activities. Fosmanogepix is a clinical-stage broad-spectrum antifungal. It has a novel mechanism of action and its active moiety has shown activity against common species of Candida and Aspergillus, including multi-drug-resistant strains, such as Candida auris and Candida glabrata, as well as rare difficult-to-treat molds including Fusarium spp., Scedosporium spp., and some fungi from the Mucorales order.1 Fosmanogepix intravenous and oral formulations have been evaluated in clinical phase 2 studies for the treatment of patients with Candidemia, including Candida auris infections, and invasive mold infections.1 A phase 3 study evaluating fosmanogepix in the treatment of adult patients with candidemia and/or invasive candidiasis is ongoing and the initiation of a second phase 3 study, in the treatment of adult patients with invasive mold infections, is expected soon.2 Fosmanogepix has received Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration for a number of indications, and is designated as a Qualified Infectious Disease Product (QIDP). BAL2062 is a first-in-class antifungal, derived from a natural product, and has demonstrated fungicidal activity against clinically important molds such as Aspergillus spp., including azole-resistant strains.3 Safety and tolerability have been demonstrated in a previously completed phase 1 study with single and multiple ascending intravenous (i.v.) doses.4 The drug candidate has Qualified Infectious Disease Product (QIDP), Orphan Drug and Fast Track designation from the US Food and Drug Administration (FDA) for invasive aspergillosis. Invasive aspergillosis and invasive infections with rare molds (e.g., Fusarium spp., Scedosporium spp., and Mucorales fungi) are life-threatening infections that predominantly affect immunocompromised patients, including patients with hematologic malignancies (blood cancer), transplant patients, or patients with other immunodeficiency disorders. These infections are associated with high morbidity and mortality.5, 6 Invasive candidiasis, including deep-seated tissue candidiasis and candidemia, is an increasingly important nosocomial infection, especially in patients hospitalized in intensive care units. Candida species are ranked as the fourth main cause of bloodstream infections in hospitals in the US.7 The prognosis of invasive candidiasis remains difficult, with a reported mortality rate for invasive candidiasis as high as 40%, even when patients receive antifungal therapy.8 Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical and clinical anti-infective assets in our portfolio. References K. J. Shaw, A. S. Ibrahim. Fosmanogepix: A Review of the First-in-Class Broad Spectrum Agent for the Treatment of Invasive Fungal Infections. Journal of Fungi (Basel) 2020 (6), 239 FAST study (candidemia/invasive candidiasis): ClinicalTrials.gov identifier NCT05421858; FORWARD study (invasive mold infections): ClinicalTrials.gov identifier NCT06925321 K. J. Shaw. GR-2397: Review of the Novel Siderophore-like Antifungal Agent for the Treatment of Invasive Aspergillosis. Journal of Fungi (Basel) 2022 (8), 909 ClinicalTrials.gov identifier NCT02956499: M. P. Mammen, D. Armas, F. H. Hughes et al. First-in-Human Phase 1 Study To Assess Safety, Tolerability, and Pharmacokinetics of a Novel Antifungal Drug, VL-2397, in Healthy Adults. Antimicrobial Agents and Chemotherapy 2019 (63), e00969-19 J. Cadena, G. R. Thompson 3rd, T. F. Patterson. Aspergillosis: Epidemiology, Diagnosis, and Treatment. Infectious Disease Clinics of North America 2021 (35), 415-434 M. Slavin, S. van Hal, T. C. Sorrell et al. Invasive infections due to filamentous fungi other than Aspergillus: epidemiology and determinants of mortality. Clinical Microbiology and Infection 2015 (21), 490.e1-490.e10 Candidemia (Blood Infection) and Other Candida Infections. 2019 Factsheet by the American Thoracic Society: https://www.thoracic.org/patients/patient-resources/resources/candidemia.pdf (Accessed: July 07, 2025) B. J. Kullberg, M. C. Arendrup. Invasive Candidiasis. The New England Journal of Medicine 2015 (373), 1445-1456 The content above comes from the network. if any infringement, please contact us to modify.

Orphan DrugFast TrackClinical Result

08 Jul 2025

·www.fiercebiotech.com

Basilea secures $39M from BARDA as part of long-term antifungal funding plan

The latest funding will support an ongoing phase 3 study of fosmanogepix in yeast infections.\n Basilea Pharmaceutica has accessed the next tranche of U.S. government funding required to continue developing its pipeline of new antifungals.The Biomedical Advanced Research and Development Authority (BARDA) signed an agreement with Basilea in September 2024 to provide funding spread over up to 12 years to “support the development of designated novel, first-in-class antifungals and antibacterials in Basilea’s portfolio.” The total funding to be handed over could top out at $268 million, but this is dependent on Basilea hitting a series of clinical and regulatory milestones, as well as BARDA choosing to extend the contract.Basilea already secured $29 million to develop its antifungals fosmanogepix and BAL2062, and the Swiss company announced this morning that it has confirmed it will also receive its next tranche of $39 million after hitting one of those undisclosed milestones.The latest funding will support an ongoing phase 3 study with fosmanogepix in yeast infections as well as launch another late-stage trial in mold infections. The broad-spectrum antifungal originates at Amplyx Pharmaceuticals, although Basilea acquired the asset from Pfizer in 2023.A portion of the fresh funds will also be used to prepare for a phase 2 study of BAL2062. Basilea bought that antifungal from Gravitas Therapeutics and has been aiming the candidate at molds like Aspergillus.“We are very pleased to receive the continued funding under the [agreement] with BARDA to support the development of our antifungal drug candidates fosmanogepix and BAL2062,” Basilea CEO David Veitch said in the July 8 release.“Both compounds offer a novel mechanism of action and represent new therapeutic options for patients with aspergillosis, candidiasis or other life-threatening fungal infections,” Veitch added. “These infections primarily affect patients with weakened immune systems, such as cancer or transplant patients.” Basilea’s relationship with BARDA stretches back to 2013 when the agency committed $89 million in funding toward the antibiotic BAL30072—although the biotech went on to scrap the candidate three years later.Basilea currently markets Cresemba for invasive fungal infections and Zevtera for bacterial infections. The low return on investment means many of the biggest biopharmas have given up working on new antifungals or antibiotics in recent years—although GSK in particular has continued to sign deals and post encouraging clinical results against infections like gonorrhea.Meanwhile, Basilea has swum against the tide, pivoting away from cancer toward anti-infectives in 2023.

Phase 3Phase 2License out/in

12 Jun 2025

·pipelinereview.com

FDA Grants Priority Review for Zoliflodacin New Drug Application for the Treatment of Uncomplicated Gonorrhea and Assigns Target PDUFA Date of December 15, 2025

FDA is expected to notify Innoviva Specialty Therapeutics regarding its decision to conduct an Advisory Committee Meeting in the Day 74 letter If approved, zoliflodacin would be the first new antibiotic for treating gonorrhea in decades WALTHAM, MA, USA & GENEVA, Switzerland I June 12, 2025 I Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc. (NASDAQ: INVA), in collaboration with the Global Antibiotic Research & Development Partnership (GARDP), today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for the New Drug Application (NDA) for zoliflodacin, an investigational first-in-class, single dose, spiropyrimidinetrione oral antibiotic for the treatment of uncomplicated gonorrhea in adults and pediatric patients 12 years and older. The FDA assigned a target action date of December 15, 2025 under the Prescription Drug User-Fee Act (PDUFA). It is expected the FDA will notify Innoviva Specialty Therapeutics regarding the FDA’s decision to conduct an Advisory Committee Meeting in the Day 74 letter. If approved, zoliflodacin would be the first new antibiotic for treating gonorrhea in decades. The U.S. FDA has granted zoliflodacin a Qualified Infectious Disease Product (QIDP) designation. This designation allows it to benefit from FDA Priority Review, and Extended Market Exclusivity. Entasis Therapeutics, Inc., the legal NDA holder and affiliate of Innoviva Specialty Therapeutics, Inc., retains the commercial rights for zoliflodacin in the major markets in North America, Europe, and Asia-Pacific. GARDP retains the right to register and commercialize the product in more than three-quarters of the world’s countries, including all low-income countries, most middle-income countries, and several high-income countries. GARDP is committed to working with its partners and local health authorities in markets where zoliflodacin receives regulatory approval to help remove access barriers to ensure treatment is available to address unmet medical needs while ensuring appropriate and sustainable use. About Uncomplicated Gonorrhea With more than 82 million new gonorrhea infections occurring globally each year, gonorrhea is the second most common bacterial sexually transmitted infection (STI), affecting both men and women, which, if left untreated, can result in serious and permanent health consequences. With the rise and spread of drug-resistant infections, the World Health Organization (WHO) has identified antimicrobial resistance (AMR) as one of the ten most critical global threats to public health. The bacterium Neisseria gonorrhoeae, which causes gonorrhea, has progressively developed resistance to most classes of antibiotics used to treat these infections, including ceftriaxone, a widely used intramuscular injection that was first made available in 1984. About Zoliflodacin Zoliflodacin is an investigational first-in-class antibacterial that is administered in a single oral dose for the treatment of uncomplicated gonorrhea. The oral route of administration simplifies treatment by providing a convenient option for patients unable to receive an intramuscular injection. Zoliflodacin has a unique mechanism of action, inhibiting a crucial bacterial enzyme called type II topoisomerase, which is essential for bacterial function and reproduction. In in vitro studies, zoliflodacin demonstrated activity against multidrug-resistant strains of Neisseria gonorrhoeae , including those resistant to ceftriaxone and azithromycin, with no cross-resistance to other antibiotics. In a pivotal Phase 3 clinical trial, zoliflodacin demonstrated non-inferiority in achieving microbiological cure at the urogenital site of infection with a single oral dose of zoliflodacin compared to a treatment regimen of a single intramuscular injection of 500mg ceftriaxone followed by 1g of oral azithromycin. The Phase 3 study found that zoliflodacin was generally well-tolerated, with no serious adverse events or deaths reported during the trial. About GARDP The Global Antibiotic Research & Development Partnership (GARDP) is a not-for-profit global health organization driven to protect people from the rise and spread of drug-resistant infections, one of the biggest threats to us all. By forging the public and private partnerships that matter, we develop and make accessible antibiotic treatments for people who need them. Vital support for our work comes from the governments of Canada, Germany, Japan, Monaco, the Netherlands, Switzerland, the United Kingdom, the Canton of Geneva, the European Union, as well as the Gates Foundation, Global Health EDCTP3, GSK, the RIGHT Foundation, the South African Medical Research Council (SAMRC) and Wellcome. About Innoviva Innoviva is a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets. Innoviva’s royalty portfolio includes respiratory assets partnered with Glaxo Group Limited (“GSK”). Innoviva is entitled to receive royalties from GSK on sales of RELVAR ® /BREO ® ELLIPTA ® and ANORO ® ELLIPTA ® . Innoviva’s other innovative healthcare assets include infectious disease and critical care assets stemming from acquisitions of Entasis Therapeutics, including XACDURO ® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use approved for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex and the investigational zoliflodacin currently being developed for the treatment of uncomplicated gonorrhea, and La Jolla Pharmaceutical Company, including GIAPREZA ® (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock and XERAVA ® (eravacycline) for the treatment of complicated intra-abdominal infections in adults. Innoviva also markets ZEVTERA® (ceftobiprole), an advanced-generation cephalosporin antibiotic, in the U.S. through an exclusive license from Basilea Pharmaceutica International Ltd, Allschwil. For more information about Innoviva, go to www.innoviva.com . For information about Innoviva Specialty Therapeutics, go to www.innovivaSpecialtytherapeutics.com . SOURCE: Innoviva

Phase 3Priority ReviewDrug ApprovalLicense out/inClinical Result

100 Deals associated with Ceftobiprole Medocaril Sodium

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KEGG	Wiki	ATC	Drug Bank
-	Ceftobiprole Medocaril Sodium	J01DI01	DB14733

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Community-acquired bacterial pneumonia	United States	ISTx LLC	03 Apr 2024
Right sided infective endocarditis	United States	ISTx LLC	03 Apr 2024
Skin and skin structure infections	United States	ISTx LLC	03 Apr 2024
Staphylococcus aureus bacteraemia	United States	ISTx LLC	03 Apr 2024
Community Acquired Pneumonia	Canada	Avir Pharma, Inc.	20 Mar 2018
Hospital-acquired pneumonia	Canada	Avir Pharma, Inc.	20 Mar 2018

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Skin Diseases, Infectious	NDA/BLA	European Union	Janssen Pharmaceutical Unlimited Co.	-
Soft Tissue Infections	NDA/BLA	European Union	Janssen Pharmaceutical Unlimited Co.	-
Neonatal Sepsis	Phase 3	United States	Basilea Pharmaceutica AG	06 Aug 2023
Neonatal Sepsis	Phase 3	Bulgaria	Basilea Pharmaceutica AG	06 Aug 2023
Neonatal Sepsis	Phase 3	Estonia	Basilea Pharmaceutica AG	06 Aug 2023
Neonatal Sepsis	Phase 3	Germany	Basilea Pharmaceutica AG	06 Aug 2023
Neonatal Sepsis	Phase 3	Latvia	Basilea Pharmaceutica AG	06 Aug 2023
Neonatal Sepsis	Phase 3	Lithuania	Basilea Pharmaceutica AG	06 Aug 2023
Neonatal Sepsis	Phase 3	Poland	Basilea Pharmaceutica AG	06 Aug 2023
Neonatal Sepsis	Phase 3	Slovakia	Basilea Pharmaceutica AG	06 Aug 2023

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03138733 (FDA_CDER) Manual	Phase 3	Staphylococcus aureus bacteraemia	387	ZEVTERA	mqarmcfkdw(tfiavheiqp) = jvxzrhatln smzeptsope (ijdoltttek ) View more	Positive	03 Apr 2024
				Daptomycin	mqarmcfkdw(tfiavheiqp) = qogipmrsdv smzeptsope (ijdoltttek ) View more
NCT00326287 \| NCT03439124 (FDA_CDER) Manual	Phase 3	Community-acquired bacterial pneumonia	-	Ceftobiprole medocaril (Adult Patients)	timqiyiuii(eakpmygmkn) = ituxqqckkr rwjsjlndur (hzmlcaatod ) View more	Positive	03 Apr 2024
				Ceftriaxone with or without Linezolid (Adult Patients)	timqiyiuii(eakpmygmkn) = jpyxvjgaqo rwjsjlndur (hzmlcaatod ) View more
NCT03137173 (FDA_CDER) Manual	Phase 3	Skin and skin structure infections	679	ZEVTERA 667 mg	xdklknzunq(qglnjmzkmt) = aeezsszswl siakkbnovb (snovmwcrxp ) View more	Positive	03 Apr 2024
				Vancomycin plus aztreonam	xdklknzunq(qglnjmzkmt) = luqedfivuc siakkbnovb (snovmwcrxp ) View more
NCT03138733 (ERADICATE, Pubmed)	Phase 3	Staphylococcus aureus bacteraemia	390	Ceftobiprole 500 mg IV every 6 hours for 8 days and every 8 hours thereafter	tpwqadjkpp(dhhlyvtwcb) = sjtcuvavdn cniollzhqf (axlyzpkrzb ) View more	Positive	12 Oct 2023
				Daptomycin 6 to 10 mg/kg IV every 24 hours plus optional aztreonam	tpwqadjkpp(dhhlyvtwcb) = vxjdpcigrp cniollzhqf (axlyzpkrzb ) View more
NCT03138733 (Trial 1 \| ERADICATE, CTgov)	Phase 3	Staphylococcus aureus bacteraemia	390	Daptomycin	katqoncavs = sxsjcymrxe lzrrknfpga (alnaheryfi, umnsjvgcht - plwlygyizb) View more	-	06 May 2023
NCT03138733 (ERADICATE, Corporate Publications) Manual	Phase 3	Staphylococcus aureus bacteraemia	390	Ceftobiprole Medocaril Sodium	kxadywzsdx(qijecjjmlw) = hbqiuvjhop ufqzpniifo (bbgzxgvqtx ) View more	Non-inferior	24 Oct 2022
				Aztreonam+Daptomycin	kxadywzsdx(qijecjjmlw) = rqxshrlelm ufqzpniifo (bbgzxgvqtx ) View more
NCT02527681 \| NCT03439124 (Pubmed \| Pediatr Infect Dis J)	Not Applicable	-	-	Ceftobiprole (Neonates and infants up to 3 months of age)	axdobdlovw(vdhujldnnq) = flkivbbytg zcemjorpqq (yxkcekhxbp ) View more	-	01 Nov 2021
				Ceftobiprole (Patients 3 months to 17 years of age)	axdobdlovw(vdhujldnnq) = xnrihnzgqr zcemjorpqq (yxkcekhxbp ) View more
NCT03137173 (TARGET, Pubmed \| Clin Infect Dis) Manual	Phase 3	Skin and skin structure infections	679	Ceftobiprole Medocaril Sodium	egalforkek(znngyzehzu) = qkfwregfmu mnxvespabk (ffwjcevihq ) View more	Non-inferior	05 Oct 2021
				Vancomycin Hydrochloride+Aztreonam	egalforkek(znngyzehzu) = hwpnduksgx mnxvespabk (ffwjcevihq ) View more
NCT03439124 (Pubmed \| Pediatr Infect Dis J)	Phase 3	Pneumonia in children	138	Ceftobiprole	wgnhrnnuag(btrppgxdkk) = ihfanrtadl xhnfmtunwl (vtfhegrybr ) View more	Positive	21 Jan 2021
				Standard-of-care IV cephalosporin treatments (ceftazidime or ceftriaxone)	wgnhrnnuag(btrppgxdkk) = levjinnqdn xhnfmtunwl (vtfhegrybr ) View more
NCT02527681 (CTgov)	Phase 1	Bacterial Infections	15	Ceftobiprole (Ceftobiprole PK Population)	jnwjicrskw(ijmbcpyein) = xhbsotclcb gifcinehlq (egrsefsqzr, umqqhnguwk - ogypgrkkrq) View more	-	06 Jan 2021
				Ceftobiprole (Ceftobiprole ITT/Safety Population)	wyvbtqgfrb(xifblndmzd) = itomuqhnuq atphcbcgyq (tmyulvpyhv, lwgjmextmp - rzrnwbdywb) View more

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