A randomized, prospective open labeled study of oral amoxicillin-clavulanate and levofloxacin with intravenous ceftriaxone and amikacin in chemotherapy induced low risk febrile neutropenia

Abstract

Background : We compared the efficacy of oral antibiotics with intravenous antibiotics in low risk febrile neutropenia. Design : A prospective, randomized study Methods: Between April 2004 - December 2005, 55 patients with low risk febrile neutropenia (expected neutropenia duration < 7 days with no co-morbid features) between 15 and 75 years of age, were randomized to receive either oral amoxicillin-clavulanate 625mg twice daily and levofloxacin -500mg once daily OR intravenous (i.v.) ceftriaxone 2g and amikacin 15mg/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. Results: A total of 64 febrile episodes were recorded (mean 1.20 ); 33 in the IV group and 31 in the oral antibiotics group. Both groups were equally matched for age (median 25 years in the IV group and 19 years in the oral group), gender, type of cancer, baseline absolute neutrophil count (median 200/cmm in both arms) and duration of neutropenia (5 days and 4 days in the IV 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. 72% in the IV arm and 77% in the oral arm responded to therapy (p=ns). One patient in IV group had one episode of seizure. Non-responding patients received second line IV antibiotics. There was no mortality in either group. Age > 60 years, neutropenia lasting > 7 days after the onset of fever and positive blood culture were predictors for lack of response to antibiotics on multivariate analysis. Conclusion: Oral antibiotics have comparable efficacy as IV antibiotics in the management of low risk febrile neutropenia.