Phase 2
N=54
Daptomycin in Treating Neutropenia and Fever in Patients With Cancer
Fever · Sweating · Hot Flashes · Infection · Neutropenia
Bottom Line
View on ClinicalTrials.gov: NCT00335478 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Aug 2011
Primary outcome: Primary: Number of Participants Who Became Afebrile Within 72 Hours of Starting Daptomycin. — 16 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Daptomycin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- OHSU Knight Cancer Institute
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Became Afebrile Within 72 Hours of Starting Daptomycin. |
16 | — |
Summary
RATIONALE: Antibiotics, such as daptomycin, may control neutropenia, fever, and infection in patients with cancer.
PURPOSE: This phase II trial is studying how well daptomycin works in treating neutropenia and fever in patients with cancer.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of cancer
- Diagnosis of neutropenic fever
- Temperature > 38.3°C once OR ≥ 38°C twice within 12 hours
- Absolute neutrophil count 1, 000 U/L (5 times upper limit of normal [ULN])
- No CPK elevations > 10 times ULN in patients with no signs or symptoms of myopathy
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 7 days since prior daptomycin or other antibiotic agents covering gram-positive organisms
- No concurrent hemodialysis or continuous ambulatory peritoneal dialysis
- No concurrent succinylcholine, ethanol, fludrocortisone, olanzapine, or pioglitazone
- No concurrent hydroxymethyl glutaryl (HMG) coenzyme A (HMG CoA) reductase inhibitors (e.g., lovastatin, simvastatin, atorvastatin)
- Concurrent therapy for gram-negative bacterial infection allowed
Data sourced from ClinicalTrials.gov (NCT00335478). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.