To determine if early discontinuation of antimicrobials in low risk febrile neutropenia is as effective as continuing therapy till recovery of counts.
Phase 3
- Conditions
- Health Condition 1: null- Pediatric cancer patients with Febrile neutropenia.
- Registration Number
- CTRI/2018/04/012988
- Lead Sponsor
- All India Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
oAll pediatric febrile neutropenia patients treated on outpatient basis with anticipated count recovery <= 10 days
oAge 3 years - 18 years
oFulfilling low risk criteria
(Hematological malignancies in remission, No identifiable focus of infection, No Pneumonia/ mucositis / GI sepsis / Nausea-vomiting/ neurologic-mental status changes/ CVC related infection, Anticipated ANC recovery < 10 days, No organ dysfunction, Hemodynamically stable, Culture negative )
oAfebrile for at least 24 hours, on intra-venous antibiotics
Exclusion Criteria
oBone marrow involvement in solid tumor
oAlready enrolled once, in previous episode
oOn antibiotics prophylaxis
oRetroviral positive patients
oPatient undergone stem cell transplant
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢Treatment is considered to be successful if the following is attained without changing the regimen <br/ ><br>ï?? Patient remains afebrile till recovery of ANC â?¥ 500 <br/ ><br>Measure of effect: Proportion of patients afebrile in each arm <br/ ><br>Timepoint: outcome will be measured till Day-10 of randomization
- Secondary Outcome Measures
Name Time Method Rate of ReadmissionTimepoint: Reappearance of fever, till D-10 of randomization