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 range
18 Years – 99 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants Who Became Afebrile Within 72 Hours of Starting Daptomycin.