Early Stoppage Versus Continuation of Antimicrobial Therapy in Low Risk Pediatric Cancer Patients With Febrile Neutropenia, Before Recovery of Counts: -DALFEN Study
Phase 3
Terminated
- Conditions
- Pediatric CancerNeutropenia, Febrile
- Registration Number
- NCT03003273
- Lead Sponsor
- All India Institute of Medical Sciences, New Delhi
- Brief Summary
Pediatric patients with febrile neutropenia coming to Department of Medical Oncology with low risk features (culture awaited), will be started on intravenous antibiotics (Inj Cefoperazone+ Sulbactam ± Amikacin) on outpatient basis. Those patients will be reassessed for randomization once they fulfill all inclusion criteria and get afebrile for at least 24 hours. Antibiotics will be stopped in Arm-A and oral antibiotics, in place of intravenous antibiotics, will be started in Arm-B. The patients will be followed-up till ANC≥ 500, or reappearance of fever within follow-up of ≤ 10 days.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 142
Inclusion Criteria
- All pediatric febrile neutropenia patients treated on outpatient basis
- Age 3 years - 18 years
- Fulfilling low risk criteria ( Hematological malignancies in remission, No identifiable focus of infection, No Pneumonia/ mucositis / GI sepsis / Nausea-vomiting/ neurologic-mental status changes/ Central Venous Catheter (CVC) related infection, Anticipated Absolute Neutrophil Count (ANC) recovery ≤ 10 days, No organ dysfunction, Hemodynamically stable, Culture negative )
- Afebrile for at least 24 hours, on intra-venous antibiotics
Exclusion Criteria
- Bone marrow involvement in solid tumor
- Already enrolled once, in previous episode
- On antibiotics prophylaxis
- Retroviral positive patients
- Patient undergone stem cell transplant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Treatment is considered to be successful if the following is attained without changing the regimen - Patient remains afebrile till recovery of ANC ≥500 •Measure of effect: Proportion of patients afebrile in each arm till ANC ≥ 500 or reappearance of fever during the period ≤ 10 days
- Secondary Outcome Measures
Name Time Method Rate of re-admission till ANC ≥ 500 or reappearance of fever during the period ≤10 days
Trial Locations
- Locations (1)
Department of Medical Oncology, AIIMS
🇮🇳New Delhi, India
Department of Medical Oncology, AIIMS🇮🇳New Delhi, India