Phase 2 Completed N=54 Supportive Care

Daptomycin in Treating Neutropenia and Fever in Patients With Cancer

Fever · Sweating · Hot Flashes · Infections

Source: ClinicalTrials.gov NCT00335478 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2011

Primary outcomePrimary: Number of Participants Who Became Afebrile Within 72 Hours of Starting Daptomycin. — 16 participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Who Became Afebrile Within 72 Hours of Starting Daptomycin.	16	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.