Randomized controlled trial comparing oral amoxicillin-clavulanate and ofloxacin with intravenous ceftriaxone and amikacin as outpatient therapy in pediatric low-risk febrile neutropenia.
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(3) 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.
Gupta
Ajay
A
Department of Medical Oncology, Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India.
Swaroop
Chetanya
C
Agarwala
Sandeep
S
Pandey
Ravindra Mohan
RM
Bakhshi
Sameer
S
D000284:Administration, Oral; D000293:Adolescent; D000553:Ambulatory Care / Q000379:methods; D000583:Amikacin / Q000008:administration & dosage / Q000627:therapeutic use*; D019980:Amoxicillin-Potassium Clavulanate Combination / Q000008:administration & dosage / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use; D002443:Ceftriaxone / Q000008:administration & dosage / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004359:Drug Therapy, Combination; D005260:Female; D005334:Fever / Q000209:etiology*; D016905:Gram-Negative Bacterial Infections / Q000188:drug therapy / Q000209:etiology; D016908:Gram-Positive Bacterial Infections / Q000188:drug therapy* / Q000209:etiology; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D009369:Neoplasms / Q000150:complications / Q000188:drug therapy; D009503:Neutropenia / Q000139:chemically induced / Q000150:complications*; D015242:Ofloxacin / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D019980:Amoxicillin-Potassium Clavulanate Combination; D002443:Ceftriaxone; D000583:Amikacin; D015242:Ofloxacin