Health Condition 1: null- FEBRILE NEUTROPENIA
Conditions
Interventions
Intervention1: ARM A: 1.Cefepime- 2g intravenous every 8 hourly for adults and 50mg/kg every 8 hrly for pediatrics
2.Duration of antibiotic therapy ranges from 3-14 days
Control Intervention1: ARM B:
Sponsors
Jipmer
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosis of hematological or solid malignancies 2. Presence of neutropenia [defined as an absolute neutrophil count (ANC) 3. Temperature >38ºC on two occasions at least 1 hr apart or 38.3º C on one occasion in 24 h in the absence of any other obvious cause of fever 4. Both adult and pediatric FN patients 5. Patients on oral antibiotic prophylaxis 6. Administration of vancomycin for relavant indication will be allowed 7. Previous evidence of fungal infection or patients on antifungal prophylaxis will be included
Exclusion criteria
Exclusion criteria: 1. History of hypersensitivity reactions and severe adverse events to beta-lactam antibiotics 2. prior use of any antibiotic(s) within one week of index episode 3. central nerve system infection, infective endocarditis, HIV infection 4. Renal dysfunction (serum creatinine >2.0 mg/dl, or creatinine clearance 5. Hepatic dysfunction ( total bilirubin >2 mg/dl) 6. Refractory hypotension at presentation 7. Lack of informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A)Positive response to study antibiotics 1) Defervescence within 48-72 hrs, with hemodynamic and clinical stability 2)For a breakthrough fever within 24-48 hrs of early antibiotic discontinuation, defervescence by another 24-48 hrs of restarting the same antibiotic and without new clinical or microbiological documented infection Timepoint: A)Positive response to study antibiotics 1) Defervescence within 48-72 hrs, with hemodynamic and clinical stability 2)For a breakthrough fever within 24-48 hrs of early antibiotic discontinuation, defervescence by another 24-48 hrs of restarting the same antibiotic and without new clinical or microbiological documented infection | — |
Secondary
| Measure | Time frame |
|---|---|
| A) Positive response to early antibiotic discontinuation approach 1) No breakthrough fever within 48 hrs Negative response to early antibiotic discontinuation approach 1) Breakthrough fever within 48 hrs Timepoint: Negative response to early antibiotic discontinuation approach 1) Breakthrough fever within 48 hrs | — |
Countries
India
Contacts
Public ContactPONRAJ M
JIPMER
Outcome results
None listed