Outpatient, sequential, parenteral-oral antibiotic therapy for lower risk febrile neutropenia in children with malignant disease: a single-center, randomized, controlled trial in Argentina.
BACKGROUND
Recent reports and previous randomized trials conducted at the authors' institution suggested that children with lower risk febrile neutropenic (LRFN) may benefit from substitution of oral antibiotic therapy for parenteral therapy. The objective of this study was to determine the efficacy of parenteral-oral outpatient therapy in the management of children with LRFN who were receiving treatment for malignant disease.


METHODS
From August 2000 to April 2002, 135 children with a median age of 7.5 years (range, 1.6-15.8 years) who had a total of 177 episodes of LRFN were included in a prospective, randomized, single-institution trial. Children with LRFN received a single dose of ceftriaxone and amikacin and completed a risk-assessment work-up. All patients were discharged immediately and, at 24 hours, were allocated randomly to two groups: Group A (89 episodes) received oral ciprofloxacin, and Group B (88 episodes) received intravenous ceftriaxone.


RESULTS
Most patients (61% in Group A and 51% in Group B) were receiving treatment for leukemia (P value not significant [NS]). Twenty-eight children (31%) in Group A and 22 children (25%) in Group B displayed unexplained fever (P value NS). No significant differences in sites of initial infection were found between the two groups. The median duration of neutropenia was 4.2 days and 4.7 days for Group A and Group B, respectively (P value NS); the median duration of fever was 2.3 days and 2.6 days, respectively (P value NS); and the median duration of antibiotic treatment was 4.5 days and 4.8 days, respectively (P value NS). The overall results of the study were excellent. Only four treatment failures in Group A (5%) and 6 treatment failures in Group B (7%) were observed. These patients were readmitted to the hospital and did well with appropriate treatment.


CONCLUSIONS
In children with LRFN who are receiving treatment for malignant disease, outpatient oral ciprofloxacin after 24 hours of a single dose of intravenous ceftriaxone and amikacin was as safe and efficacious as parenteral ceftriaxone. Outpatient management and early antibiotic withdrawal were safe for both groups.
Paganini
Hugo
H
Department of Infectious Diseases and Epidemiology, Hospital de Pediatría Profesor Dr. Juan P. Garrahan, Buenos Aires, Argentina. hpaganini@intramed.net.ar
Gómez
Sandra
S
Ruvinsky
Silvina
S
Zubizarreta
Pedro
P
Latella
Antonio
A
Fraquelli
Lidia
L
Iturres
Alejandro Santillán
AS
Casimir
Lidia
L
Debbag
Roberto
R
D000284:Administration, Oral; D000293:Adolescent; D000553:Ambulatory Care; D000583:Amikacin / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D000970:Antineoplastic Agents / Q000009:adverse effects; D001118:Argentina; D002443:Ceftriaxone / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D002939:Ciprofloxacin / Q000627:therapeutic use; D005260:Female; D005334:Fever / Q000188:drug therapy*; D006801:Humans; D007223:Infant; D007938:Leukemia / Q000188:drug therapy; D008297:Male; D009503:Neutropenia / Q000188:drug therapy* / Q000209:etiology; D012306:Risk
D000900:Anti-Bacterial Agents; D000970:Antineoplastic Agents; D002939:Ciprofloxacin; D002443:Ceftriaxone; D000583:Amikacin