Trial · NCT00529282

A Study of Ceftobiprole in Patients With Fever and Neutropenia.

NCT00529282, Phase 3, Terminated, Basilea Pharmaceutica; results first posted 2010-03-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of Ceftobiprole in Patients With Fever and Neutropenia. Trials, record NCT00529282. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00529282

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Trial

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

Title: A Study of Ceftobiprole in Patients With Fever and Neutropenia.
NCT number: NCT00529282
Status: Terminated
Phases: Phase 3
Enrollment: 2 participants, actual
Lead sponsor: Basilea Pharmaceutica
Conditions: Fever, Neutropenia, Gram-positive Bacterial Infections, Pseudomonas Infection
Interventions: Ceftobiprole Medocaril, Cefepime with or without vancomycin
First posted: 2007-09-14
Last updated: 2012-08-01
Results first posted: 2010-03-29
Limitations and caveats: No analysis was performed due to early termination of the study.

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Clinical Cure Rate of Ceftobiprole vs Comparator in Patients With Fever and Neutropenia.	7 to 10 days after end of therapy or before 24 hours of the initiation of the next course of chemotherapy, whichever is shorter.	Clinical cure rate (the ratio of the number of clinically cured patients to the total number of patients in the population) at 7 to 10 days after end of therapy or before 24 hours of the initiation of the next course of chemotherapy, whichever is shorter. Cure without modification: A subject will be considered to be cured at the primary efficacy visit if: The subject's fever and clinical signs and symptoms are resolved to the extent that no further anti-infective therapy is necessary as determined by the investigator Any infecting organisms that were identified at baseline were eradicated
Secondary	Clinical Cure Regardless of Modification of Therapy	7 to 10 days after end of therapy or before 24 hours of the initiation of the next course of chemotherapy, whichever is shorter.	To demonstrate the noninferiority of ceftobiprole compared with cefepime with or without vancomycin with regard to clinical cure at the primary efficacy visit after completing the initial course of therapy, regardless of modification of therapy defined as addition of an anti-fungal agent and/or an aminoglycoside. Cure with modification: The subject requires antifungals, which will be considered a failure for the primary endpoint. The subject needs modification of study therapy by adding one or more agents (other than protocol-defined chemoprophylaxis antibiotics).
Secondary	Clinical Success at 72 Hours	72 hours after starting study drug	To compare the clinical success rate (absence or improvement of signs and symptoms of infection) at 72 hours after starting ceftobiprole with that of cefepime with or without vancomycin
Secondary	Clinical Cure Without Prophylactic Antibiotics After the End-of-treatment (EOT) Visit up to 28 Days of Study Drug	7 to 10 days after end of therapy or before 24 hours of the initiation of the next course of chemotherapy, whichever is shorter.	To demonstrate the noninferiority of ceftobiprole compared with cefepime with or without vancomycin with regard to clinical cure at the primary efficacy visit after completing the unmodified initial course of therapy, and receiving no prophylactic antibiotics after the EOT visit.

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Population
PRIMARY	Clinical Cure Rate of Ceftobiprole vs Comparator in Patients With Fever and Neutropenia.	7 to 10 days after end of therapy or before 24 hours of the initiation of the next course of chemotherapy, whichever is shorter.	No outcome measures were analyzed due to early termination of the study.
SECONDARY	Clinical Cure Regardless of Modification of Therapy	7 to 10 days after end of therapy or before 24 hours of the initiation of the next course of chemotherapy, whichever is shorter.	No outcome measures were analyzed due to early termination of the study.
SECONDARY	Clinical Success at 72 Hours	72 hours after starting study drug	No outcome measures were analyzed due to early termination of the study.
SECONDARY	Clinical Cure Without Prophylactic Antibiotics After the End-of-treatment (EOT) Visit up to 28 Days of Study Drug	7 to 10 days after end of therapy or before 24 hours of the initiation of the next course of chemotherapy, whichever is shorter.	No outcome measures were analyzed due to early termination of the study.

Source ClinicalTrials.gov

Results by group0

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

None in this release.

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Ceftobiprole Medocaril	0
Overall Study	STARTED	Cefepime With or Without Vancomycin	2
Overall Study	COMPLETED	Ceftobiprole Medocaril	0
Overall Study	COMPLETED	Cefepime With or Without Vancomycin	2
Overall Study	NOT COMPLETED	Ceftobiprole Medocaril	0
Overall Study	NOT COMPLETED	Cefepime With or Without Vancomycin	0

Source ClinicalTrials.gov

Adverse events50

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	Anorectal disorder	Gastrointestinal disorders	Ceftobiprole Medocaril	0	0
other	Anorectal disorder	Gastrointestinal disorders	Cefepime With or Without Vancomycin	1	2
other	Diarrhoea	Gastrointestinal disorders	Ceftobiprole Medocaril	0	0
other	Diarrhoea	Gastrointestinal disorders	Cefepime With or Without Vancomycin	1	2
other	Dyspepsia	Gastrointestinal disorders	Ceftobiprole Medocaril	0	0
other	Dyspepsia	Gastrointestinal disorders	Cefepime With or Without Vancomycin	1	2
other	Constipation	Gastrointestinal disorders	Ceftobiprole Medocaril	0	0
other	Constipation	Gastrointestinal disorders	Cefepime With or Without Vancomycin	2	2
other	Stomatitis	Gastrointestinal disorders	Ceftobiprole Medocaril	0	0
other	Stomatitis	Gastrointestinal disorders	Cefepime With or Without Vancomycin	1	2

1 to 10 of 50Source ClinicalTrials.gov

See all 50 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ceftobiprole Medocaril
Total, all-cause mortality	Cefepime With or Without Vancomycin
Total, other adverse events	Ceftobiprole Medocaril	0	0
Total, other adverse events	Cefepime With or Without Vancomycin	2	2
Total, serious adverse events	Ceftobiprole Medocaril	0	0
Total, serious adverse events	Cefepime With or Without Vancomycin	2	2

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons0

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

None in this release.

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/NCT00529282

GET https://conductscience.org/api/trials/v1/NCT00529282/events?page=2

API reference For AI assistants