Clinical trial · Interventional
Daptomycin in Treating Neutropenia and Fever in Patients With Cancer
Phase II Open Label Pilot Trial of Empiric Daptomycin Treatment for Oncology Patients With Neutropenic Fever
NCT00335478CI-TRIAL-00027446completedPhase 2Results postedClinicalTrials.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)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fever | — | UNRESOLVED | — |
| Hot Flashes | — | UNRESOLVED | — |
| Infection | — | UNRESOLVED | — |
| Neutropenia | — | UNRESOLVED | — |
| Sweating | — | UNRESOLVED | — |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Daptomycin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Daptomycin
- interventionNames
- Drug: Daptomycin
Primary outcomes (1)
- measure
- Number of Participants Who Became Afebrile Within 72 Hours of Starting Daptomycin.
- timeFrame
- Within 72 hours of starting daptomycin
- description
- If after 72 hours of daptomycin treatment, the patient is afebrile and has absolute neutrophil count (ANC) \>500 cells/mm\^3 for 48 hours with no site of infection, negative cultures, and no clinical indications for therapy, the antibiotic regimen will be discontinued. Complete Response: Resolution of fever and clinical signs/symptoms of infection. Partial Response: Resolution of fever without resolution of clinical signs of infection.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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 preclude study compliance
* No signs or symptoms of myopathy with creatine phosphokinase (CPK) elevation \> 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 allowedReferences
Publications (0)
Data not yet available
No reference posted for this study.