| Title | Randomized Control Trial Comparing Oral Amoxicillin-clavulanate and Ofloxacin With Intravenous Ceftriaxone and Amikacin as Outpatient Therapy in Pediatric Low-risk Febrile Neutropenia. | | Author(s) | Gupta A, Swaroop C, Agarwala S, Pandey RM, Bakhshi S | | Institution | *Department of Medical Oncology, Institute Rotary Cancer Hospital daggerDepartment of Pediatric Surgery double daggerDepartment of Biostatistics, All India Institute of Medical Sciences, New Delhi, India. | | Source | J Pediatr Hematol Oncol 2009 Aug 13. | | Abstract | BACKGROUND: Outpatient oral therapy is infrequently used in pediatric low-risk febrile neutropenia (LRFN) as there is insufficient data regarding its equivalence as compared with parenteral therapy.
METHODS: This is a single institutional, randomized control trial in pediatric LRFN aged 2 to 15 years, in which 123 episodes in 88 patients were randomized to outpatient oral ofloxacin 7.5 mg/kg 12 hourly and amoxycillin-clavulanate 12.5 mg/kg 8 hourly or outpatient intravenous (IV) ceftriaxone 75 mg/kg and amikacin 15 mg/kg once daily after blood cultures.
RESULTS: Out of 119 evaluable episodes, one-third were leukemia patients in maintenance and rest were solid tumors. Success was achieved in 55/61 (90.16%) and 54/58 (93.1%) in oral and IV arms, respectively, (P=0.56). There were 3 hospitalizations but no mortality. Median days to resolution of fever, absolute neutrophil count >500/mm and antibiotic use were 3, 5, and 6 days in both arms. There were 5 blood culture isolates (3 gram-positive and 2 gram-negative bacteria). Failure of outpatient therapy was associated with perianal infections, bacteremia, febrile neutropenia onset before day 9 of chemotherapy in solid tumors and Vincristine, actinomycin-D, and cyclophosphamide chemotherapy for rhabdomyosarcoma. All gram-positive isolates were successes, whereas both gram-negative isolates were failures. Diarrhea in IV arm and Vincristine, actinomycin-D, and cyclophosphamide chemotherapy in the oral arm predicted failure in subgroup analysis.
CONCLUSIONS: Outpatient therapy is efficacious and safe in pediatric LRFN. There was no difference in outcome in oral versus IV outpatient therapy. Amoxycillin-clavulanate and ofloxacin may be the oral regimen of choice. | | Language | ENG | | Pub Type(s) | JOURNAL ARTICLE
| | PubMed ID | 19684522 |
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