18551 Background: Empiric oral antibiotic administration is a treatment option in low risk febrile neutropenia. Methods: Low risk febrile neutropenia patients (expected neutropenic duration <7 days with no comorbid features) between 15 and 75 years of age were randomized to receive either oral amoxicillin-clavulanate 625 mg twice daily and levofloxacin 500 mg once daily or intravenous (i.v.) ceftriaxone 2 g and amikacin 15 mg/kg once daily. Most patients were treated on out patient basis. The primary end point was response to therapy- defervescence of fever within 72 hours with improvement in any clinical manifestation of infection and no recurrence of fever for 48 hours without use of antipyretics. Use of growth factors was not permitted except in treatment failure. The study was cleared by the institute ethics committee. Results: Sixty four episodes in 53 patients were evaluable, 33 in the i.v. group and 31 in the oral antibiotics group. The underlying diagnosis was bone and soft tissue sarcomas in 32 episodes, hematological cancers in 22 and other solid cancers in 10. The groups were equally matched for age (median 25 years in the i.v. arm and 19 years in the oral arm), gender, type of cancer, baseline absolute neutrophil count (median 200/μL in both arms) and duration of neutropenia (5 days and 4 days in the i.v. and oral groups respectively). A focus of infection was identified clinically in 15% of episodes and microbiologically in 11% of episodes; 57% of which were gram positive organisms and the rest gram negative. Seventy two percent (95% confidence interval 58% to 88%) in the i.v. arm and 77% (95% confidence interval 63% to 92%) in the oral arm responded to therapy. The only serious toxicity was one episode of convulsions in the i.v. group. All treatment failures received second line i.v. antibiotics. There was no mortality in either group. Comparing the two groups for equivalence (assuming a 25% difference between the two arms as unequal) the two groups were found to be equivalent with a power of 59% (p = 0.03). Conclusion: Oral antibiotics have comparable efficacy as intravenous antibiotics in the management of low risk febrile neutropenia. No significant financial relationships to disclose.
Oral amoxicillin versus intravenous ampicillin for chest indrawing pneumonia in children aged 3–59 months: A randomized control trial
