Daptomycin in Treating Neutropenia and Fever in Patients With Cancer (NCT00335478) | Clinical Trial Compass
CompletedPhase 2
Daptomycin in Treating Neutropenia and Fever in Patients With Cancer
United States54 participantsStarted 2006-12
Plain-language 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.
Who can participate
Age range18 Years – 99 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Diagnosis of cancer
* Diagnosis of neutropenic fever
* Temperature \> 38.3°C once OR ≥ 38°C twice within 12 hours
* Absolute neutrophil count \< 500/mm\^³ and ≥ 1 of the following:
* Mucositis
* Concurrent skin or soft tissue infection
* Indwelling catheter and/or suspected catheter infection
* Recent quinolone prophylaxis
* Positive blood cultures for gram-positive cocci before final identification or other documented gram-positive pathogen
* Colonization with β-lactam resistant gram-positive organisms (commonly the nares or the skin)
* Hypotension, tachycardia, narrowed pulse pressures, tachypnea, or other signs of cardiovascular compromise
* Expected duration of neutropenia ≥ 3 days
* No known infection with daptomycin-resistant organism or gram-negative organism and not yet meeting criteria for the addition of gram-positive antimicrobial therapy
* No suspected meningitis or osteomyelitis
* No documented or suspected gram-positive pneumonia
* No suspected or proven endocarditis
PATIENT CHARACTERISTICS:
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Life expectancy ≥ 2 weeks
* Creatinine clearance ≥ 50 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective double-method contraception
* No known sensitivity to daptomycin or product excipients
* No history of or concurrent rhabdomyolysis
* No HIV positivity
* No psychiatric disorders that would pre…
What they're measuring
1
Number of Participants Who Became Afebrile Within 72 Hours of Starting Daptomycin.