Evidence map›Paper›PMID 32897367›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2021

Ceftobiprole Compared With Vancomycin Plus Aztreonam in the Treatment of Acute Bacterial Skin and Skin Structure Infections: Results of a Phase 3, Randomized, Double-blind Trial (TARGET).

J Scott Overcash, Charles Kim, Richard Keech, Illia Gumenchuk, Borislav Ninov, Yaneicy Gonzalez-Rojas, Michael Waters, Simeon Simeonov, Marc Engelhardt, Mikael Saulay and 4 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03137173 (A Randomized, Double-blind, Multicenter Study to Establish the Safety and Efficacy of Ceftobiprole Medocaril Compared With Vancomycin Plus Aztreonam in the Treatment of Acute Bacterial Skin and Skin Structure Infections), which is not on this map. Cited by 22 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03137173 phase3completednot on this map

A Randomized, Double-blind, Multicenter Study to Establish the Safety and Efficacy of Ceftobiprole Medocaril Compared With Vancomycin Plus Aztreonam in the Treatment of Acute Bacterial Skin and Skin Structure Infections

TypeinterventionalSponsorBasilea PharmaceuticaRan2018 to 2019Enrolled679ConditionsAcute Bacterial Skin and Skin Structure InfectionsArmsceftobiprole medocaril, vancomycin+aztreonam
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 1 synthesis or guideline pooled it, 64 citations in OpenAlex.

  1. Pooled it
  2. The global epidemiology of MRSA.JAC-antimicrobial resistance · 2026
    Review
  3. Challenges and opportunities in the management of severe pneumonia. Key concepts from the Seventh Annual Meeting of Spanish Experts 2025.Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2026
    Review
  4. Article
  5. Review
  6. Review
  7. Towards a holistic approach to pulmonary infections. Insights from the Sixth Annual Meeting of Spanish Experts 2024.Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2025
    Review
  8. Review
  9. Article
  10. Treatment of MRSA Infection: Where are We?Current medicinal chemistry · 2024
    Review
  11. Article
  12. Review
  13. Article
  14. Article
  15. Article
  16. JAC-antimicrobial resistance · 2022
    Article
  17. Review
  18. Review
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 6 institutions in 4 countries.

J Scott OvercasheStudySite Clinical Research, San Diego, California, USA.
Charles KimPhysician Alliance Research Center, Anaheim, California, USA.
Richard KeechSaint Joseph's Clinical Research, Anaheim, California, USA.
Illia GumenchukVinnytsia M. I. Pyrohov Regional Clinical Hospital, Vinnytsia, Ukraine.
Borislav NinovUMBAL, Pleven, Bulgaria.
Yaneicy Gonzalez-RojasOptimus U Corp, Coral Gables, Florida, USA.
Michael WaterseStudySite Clinical Research, San Diego, California, USA.
Simeon SimeonovClinic of Endocrinology, Medical University, Plovdiv, Bulgaria.
Marc EngelhardtBasilea Pharmaceutica International Ltd., Basel, Switzerland.
Mikael SaulayBasilea Pharmaceutica International Ltd., Basel, Switzerland.
Daniel IonescuBasilea Pharmaceutica International Ltd., Basel, Switzerland.
Jennifer I SmartBasilea Pharmaceutica International Ltd., Basel, Switzerland.
Mark E JonesBasilea Pharmaceutica International Ltd., Basel, Switzerland.
Kamal A HamedBasilea Pharmaceutica International Ltd., Basel, Switzerland.
Basilea Pharmaceutica (Switzerland) · CHTherapeutics Clinical Research · USAnaheim University · USMedical University Plovdiv · BGSaint Joseph's University · USVinnytsia National Technical University · UA

Funding

ASPR HHSBiomedical Advanced Research and Development Authority HHSO100201600002CHHS
6 · The paper itself

Abstract

backgroundThe development of novel broad-spectrum antibiotics, with efficacy against both gram-positive and gram-negative bacteria, has the potential to enhance treatment options for acute bacterial skin and skin structure infections (ABSSSIs). Ceftobiprole is an advanced-generation intravenous cephalosporin with broad in vitro activity against gram-positive (including methicillin-resistant Staphylococcus aureus) and gram-negative pathogens.

methodsTARGET was a randomized, double-blind, active-controlled, parallel-group, multicenter, phase 3 noninferiority study that compared ceftobiprole with vancomycin plus aztreonam. The Food and Drug Administration-defined primary efficacy endpoint was early clinical response 48-72 hours after treatment initiation in the intent-to-treat (ITT) population and the European Medicines Agency-defined primary endpoint was investigator-assessed clinical success at the test-of-cure (TOC) visit. Noninferiority was defined as the lower limit of the 95% CI for the difference in success rates (ceftobiprole minus vancomycin/aztreonam) >-10%. Safety was assessed through adverse event and laboratory data collection.

resultsIn total, 679 patients were randomized to ceftobiprole (n = 335) or vancomycin/aztreonam (n = 344). Early clinical success rates were 91.3% and 88.1% in the ceftobiprole and vancomycin/aztreonam groups, respectively, and noninferiority was demonstrated (adjusted difference: 3.3%; 95% CI: -1.2, 7.8). Investigator-assessed clinical success at the TOC visit was similar between the 2 groups, and noninferiority was demonstrated for both the ITT (90.1% vs 89.0%) and clinically evaluable (97.9% vs 95.2%) populations. Both treatment groups displayed similar microbiological success and safety profiles.

conclusionsTARGET demonstrated that ceftobiprole is noninferior to vancomycin/aztreonam in the treatment of ABSSSIs, in terms of early clinical response and investigator-assessed clinical success at the TOC visit. CLINICAL TRIALS REGISTRATION: NCT03137173.

Indexed as

Methicillin-Resistant Staphylococcus aureusSkin Diseases, BacterialAnti-Bacterial AgentsAztreonamCephalosporinsDouble-Blind MethodGram-Negative BacteriaGram-Positive BacteriaHumansTreatment OutcomeVancomycinAnti-Bacterial AgentsAztreonamceftobiproleCephalosporinsVancomycinABSSSIbacterial skin infectionsceftobiprole

Identifiers

PMID32897367
PMCPMC8492220
OpenAlexW3084049874

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.