A clinical trial to study the two antibiotic regimen cefepime and cefeperazone/Sulbactum plus Amikacin in cancer patients with fever

Phase 3

Completed

Conditions: Health Condition 1: null- FEBRILE NEUTROPENIA

Registration Number: CTRI/2017/06/008829

Lead Sponsor: Jipmer

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 334

Inclusion Criteria

1.Diagnosis of hematological or solid malignancies

2. Presence of neutropenia [defined as an absolute neutrophil count (ANC) <500 cells/mmÂ³ or if count <1000 cells/mmÂ³ and expected to fall <500 cells/mmÂ³ within 24â??48hours because of preceding chemotherapy

3.Temperature >38ÂºC on two occasions at least 1 hr apart or 38.3Âº 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

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 <60ml/min)

5.Hepatic dysfunction ( total bilirubin >2 mg/dl)

6.Refractory hypotension at presentation

7.Lack of informed consent

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A)Positive response to study antibiotics <br/ ><br> 1) Defervescence within 48-72 hrs, with hemodynamic and clinical stability <br/ ><br> 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 <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: A)Positive response to study antibiotics <br/ ><br> 1) Defervescence within 48-72 hrs, with hemodynamic and clinical stability <br/ ><br> 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 <br/ ><br> <br/ ><br> <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
A) Positive response to early antibiotic discontinuation approach <br/ ><br> <br/ ><br> 1) No breakthrough fever within 48 hrs <br/ ><br> <br/ ><br>Negative response to early antibiotic discontinuation approach <br/ ><br> 1) Breakthrough fever within 48 hrs <br/ ><br>Timepoint: Negative response to early antibiotic discontinuation approach <br/ ><br> 1) Breakthrough fever within 48 hrs <br/ ><br>