Clinical trial · Interventional
A Study of Ceftobiprole in Patients With Fever and Neutropenia.
Multicenter, Randomized, Double-Blind Study of Ceftobiprole Versus Comparators in the Treatment of Patients With Fever and Neutropenia
NCT00529282CI-TRIAL-00007654terminatedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study discontinued due to administrative reasons unrelated to safety
Summary
Brief summary (as posted)
The purpose of this study is to assess the safety and efficacy of ceftobiprole versus a comparator in patients with fever and neutropenia
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fever | — | UNRESOLVED | — |
| Gram-positive Bacterial Infections | — | UNRESOLVED | — |
| Neutropenia | — | UNRESOLVED | — |
| Pseudomonas Infection | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cefepime with or without vancomycin | Drug | — | UNRESOLVED |
| Ceftobiprole Medocaril | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 001
- description
- Ceftobiprole Medocaril 500 mg every 8 hours 120-minute infusion \[250 mL\]
- interventionNames
- Drug: Ceftobiprole Medocaril
- type
- ACTIVE_COMPARATOR
- label
- 002
- description
- Cefepime with or without vancomycin 2 g every 8 hrs-30 min infusion vancomycin 1 000mg every 12 hrs-60 min infusion
- interventionNames
- Drug: Cefepime with or without vancomycin
Primary outcomes (1)
- measure
- Clinical Cure Rate of Ceftobiprole vs Comparator in Patients With Fever and Neutropenia.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with neutropenia and fever associated with administration of chemotherapy for cancer that requires intravenous therapy with antibiotics. Exclusion Criteria: * Patients who have received antibacterial (oral or intravenous ) treatment for more than 24 hours for fever and neutropenia or have received systemic antibacterial therapy in the previous 72 hours for a defined infectious disease * Patients with known or suspected hypersensitivity to any related anti-infective * patients with hepatic impairment * Patients with severe renal impairment * Patients who are pregnant or lactating * Patients who are likely to require major surgical intervention for infection.
References
Publications (0)
Data not yet available
No reference posted for this study.