Clinical trial · Interventional
Treatment of Neutropenic Patients With Fever Who Are Suspected to Have A Gram Positive Infection
A Randomized, Double-Blind Trial Comparing Linezolid To Vancomycin In The Empiric Treatment Of Febrile Neutropenic Oncology Patients With Suspected Gram-Positive Infections
NCT00035425CI-TRIAL-00002832completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will treat patients who have fever and neutropenia (after cancer chemotherapy) that is possibly due to a specific bacteria (gram positive bacteria).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Febrile Neutropenia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| linezolid | Drug | — | UNRESOLVED |
| vancomycin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A.
- description
- Patients will be stratified according to the use of prophylactic antibiotics. Both groups may receive open-label gram-negative coverage with either ceftazidime, aztreonam, and/or aminoglycosides (gentamicin, tobramycin, amikacin). Subjects will receive study medication intravenously every 12 hours for 7 to 28 days.
- interventionNames
- Drug: linezolid
- type
- EXPERIMENTAL
- label
- B.
- interventionNames
- Drug: vancomycin
Primary outcomes (1)
- measure
- Clinical efficacy of linezolid when administered intravenously as compared to intravenously administered vancomycin in the empiric treatment of oncology patients with febrile neutropenia with suspected gram-positive infections.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 13 Years
Show eligibility criteria text
Inclusion Criteria: Patients must have neutropenia (ANC less than 500) with fever (oral temp 38.3 C). Patients must have a cancer with recent chemotherapy and risks factors for gram positive infections. Exclusion Criteria: Patients with fever due to known causes. Patients with HIV. Patients with recent bone marrow transplant. Patients with an infected indwelling catheter that cannot be removed. Patients who have received more than one day of another antibiotic before entering the trial. Patients with endocarditis, osteomyelitis, meningitis, CNS infections.
References
Publications (0)
Data not yet available
No reference posted for this study.