Trial · NCT03137173

Ceftobiprole in the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infections

NCT03137173, Phase 3, Completed, Basilea Pharmaceutica; results first posted 2020-05-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Ceftobiprole in the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infections. Trials, record NCT03137173. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03137173

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Ceftobiprole in the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infections
NCT number: NCT03137173
Status: Completed
Phases: Phase 3
Enrollment: 679 participants, actual
Lead sponsor: Basilea Pharmaceutica
Conditions: Acute Bacterial Skin and Skin Structure Infections
Interventions: ceftobiprole medocaril, vancomycin+aztreonam
First posted: 2017-05-02
Last updated: 2026-09-18
Results first posted: 2020-05-18

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Early Clinical Response	48-72 hours after start of study drug treatment	Comparison of early clinical response, including ≥ 20% reduction from baseline in the primary lesion area (based on ruler measurements), survival for ≥ 72 hours and no rescue therapy in the ITT population
Secondary	Investigator-assessed Clinical Success in the ITT Population	15-22 days after randomization	Comparison of investigator-assessed clinical success (based on resolution of baseline signs and symptoms of the primary infection) in the ITT population
Secondary	Investigator-assessed Clinical Success in the Clinically Evaluable (CE) Population	15-22 days after randomization	Comparison of investigator-assessed clinical success (based on resolution of baseline signs and symptoms of the primary infection) in the clinically evaluable (CE) population

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Early Clinical Response	48-72 hours after start of study drug treatment	ITT population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Investigator-assessed Clinical Success in the ITT Population	15-22 days after randomization	ITT population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Investigator-assessed Clinical Success in the Clinically Evaluable (CE) Population	15-22 days after randomization	CE population	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Early Clinical Response	Ceftobiprole Medocaril	306	Participants
Early Clinical Response	Vancomycin+Aztreonam	303	Participants
Investigator-assessed Clinical Success in the ITT Population	Ceftobiprole Medocaril	302	Participants
Investigator-assessed Clinical Success in the ITT Population	Vancomycin+Aztreonam	306	Participants
Investigator-assessed Clinical Success in the Clinically Evaluable (CE) Population	Ceftobiprole Medocaril	277	Participants
Investigator-assessed Clinical Success in the Clinically Evaluable (CE) Population	Vancomycin+Aztreonam	279	Participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Ceftobiprole Medocaril	335
Overall Study	STARTED	Vancomycin+Aztreonam	344
Overall Study	COMPLETED	Ceftobiprole Medocaril	309
Overall Study	COMPLETED	Vancomycin+Aztreonam	308
Overall Study	NOT COMPLETED	Ceftobiprole Medocaril	26
Overall Study	NOT COMPLETED	Vancomycin+Aztreonam	36

Source ClinicalTrials.gov

Adverse events48

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Nausea	Gastrointestinal disorders	Ceftobiprole Medocaril	36	334
other	Nausea	Gastrointestinal disorders	Vancomycin+Aztreonam	20	342
other	Diarrhoea	Gastrointestinal disorders	Ceftobiprole Medocaril	21	334
other	Diarrhoea	Gastrointestinal disorders	Vancomycin+Aztreonam	16	342
other	Headache	Nervous system disorders	Ceftobiprole Medocaril	19	334
other	Headache	Nervous system disorders	Vancomycin+Aztreonam	24	342
serious	CARDIAC ARREST	Cardiac disorders	Ceftobiprole Medocaril	0	334
serious	CARDIAC ARREST	Cardiac disorders	Vancomycin+Aztreonam	1	342
serious	ABDOMINAL PAIN	Gastrointestinal disorders	Ceftobiprole Medocaril	0	334
serious	ABDOMINAL PAIN	Gastrointestinal disorders	Vancomycin+Aztreonam	1	342

1 to 10 of 48Source ClinicalTrials.gov

See all 48 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ceftobiprole Medocaril	1	334
Total, all-cause mortality	Vancomycin+Aztreonam	3	342
Total, other adverse events	Ceftobiprole Medocaril	63	334
Total, other adverse events	Vancomycin+Aztreonam	47	342
Total, serious adverse events	Ceftobiprole Medocaril	6	334
Total, serious adverse events	Vancomycin+Aztreonam	12	342

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
32897367	DERIVED	PubMed
33960817	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons5

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Ceftobiprole Medocaril vs Vancomycin+Aztreonam: Early Clinical Response	Trial comparisons
Ceftobiprole Medocaril vs Vancomycin+Aztreonam: Investigator-assessed Clinical Success in the ITT Population	Trial comparisons
Ceftobiprole Medocaril vs Vancomycin+Aztreonam: deaths from any cause	Trial comparisons
Ceftobiprole Medocaril vs Vancomycin+Aztreonam: Investigator-assessed Clinical Success in the Clinically Evaluable (CE) Population	Trial comparisons
Ceftobiprole Medocaril vs Vancomycin+Aztreonam: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03137173

GET https://conductscience.org/api/trials/v1/NCT03137173/events?page=2

API reference For AI assistants