Subject(s)
Azithromycin/administration & dosage , Cefixime/administration & dosage , Dysentery, Bacillary/drug therapy , Shigella/drug effects , Shigella/isolation & purification , Chi-Square Distribution , Child, Preschool , Dose-Response Relationship, Drug , Drug Administration Schedule , Dysentery, Bacillary/diagnosis , Feces/microbiology , Female , Follow-Up Studies , Humans , Infant , Male , Paraguay , Prospective Studies , Reference Values , Risk Assessment , Severity of Illness Index , Treatment OutcomeABSTRACT
BACKGROUND: Recent reports and a previous randomized trial conducted at the authors' institution suggested that a lower risk subset of children with febrile neutropenia under chemotherapy might benefit of an oral antibiotic outpatient approach. METHODS: The objective of this study was to test the efficacy of oral ciprofloxacin in the treatment of lower risk febrile neutropenia (LRFN) in children treated for malignant diseases. From November 1998 to December 1999, 93 episodes of LRFN in 87 children (median age, 5.5 years; range, 0.9-15.8 years) were included in a prospective randomized controlled single institution trial. Inclusion criteria included fever (> 38 degrees C), severe neutropenia (absolute neutrophil count, < 500/mm(3)), and lower risk features (e.g., absence of severe comorbidity factors, good clinical condition, negative blood cultures, control of local infection, prediction of a period of neutropenia less than 10 days after admission, and compliant parents). After 24 hours of a single intravenous ceftriaxone (100 mg/kg) plus amikacin (15 mg/kg) and completed risk assessment workup, patients were discharged and randomly allocated to two groups. Group A (48 episodes) received ciprofloxacin 20 mg/kg/day orally (p.o.) every 12 hours for 6 days. Group B (45 episodes) received intravenous ceftriaxone plus amikacin for 2 days more followed by cefixime (8 mg/kg/day p.o.) every 24 hours for 4 additional days. Failure was defined as the need of a second hospitalization during the same episode. RESULTS: Most of the patients (59% in Group A and 52% in Group B) were treated for malignant solid tumors. Fifteen (31%) children in Group A and 15 (33%) in Group B presented with fever of unknown origin (P value was not significant). No significant differences were found in sites of initial infection between both groups. Overall results in this study were excellent. Only one patient with respiratory failure was detected in Group B, who did well with secondary treatment. CONCLUSIONS: In febrile neutropenic children after anticancer therapy and lower risk features, oral ciprofloxacin for 6 days after 24 hours of intravenous ceftraxione plus amikacin appears to be as efficacious as intravenous ceftriaxone plus amikacin for 2 days more followed by cefixime for 4 additional days. These results contribute to strengthen the concept of LRFN.
Subject(s)
Anti-Infective Agents/administration & dosage , Anti-Infective Agents/pharmacology , Ciprofloxacin/administration & dosage , Fever/drug therapy , Neutropenia/drug therapy , Administration, Oral , Adolescent , Amikacin/administration & dosage , Anti-Bacterial Agents/administration & dosage , Antineoplastic Agents/adverse effects , Antineoplastic Agents/therapeutic use , Cefixime/administration & dosage , Cephalosporins/administration & dosage , Child , Child, Preschool , Female , Fever/complications , Fever/etiology , Fever of Unknown Origin/complications , Fever of Unknown Origin/drug therapy , Fever of Unknown Origin/etiology , Humans , Infant , Infusions, Intravenous , Male , Neoplasms/complications , Neoplasms/drug therapy , Neutropenia/complications , Neutropenia/etiology , Risk Factors , Treatment OutcomeABSTRACT
Introducción.Para el tratamiento parenteral-oral con ceftriaxona y amikacina seguido de cefixima en niños con neutropenia y fiebre de causa hemato-oncológica,se realizó un estudio prospectivo entre los meses de mayo de 1997 y noviembre de 1999.Métodos.Durante dicho período fueron incluidos 101 episodios de neutropenia(neutrófilos menor 500/mm3 o recuento entre 500 y 1000/mmm3 y caida mayor 25 por ciento en la última semana)y fiebre(un pico febril >38,5 grados C o dos >38,1 grados C)en niños con enfermedad hemato-oncológica de bajo riesgo.Se definió al paciente de bajo riesgo como aquél que no presentaba signos severos de cormobilidad asociados(sangrados incoercibles,trastornos metabólicos refractarios al tratamiento,insuficiencia renal,hepática o respiratoria)mala condición clínica,predicción de padecer neutropenia más de 10 días no celulitis(de boca,periné,sobre el catéter)enteritis o mucositis severa.Todos los pacientes recibieron ceftriaxona(100 mg/kg/día,EV cada 24 horas)junto a amikacina(15mg/kg/día,EV cada 24 horas)durante 3 días,seguido de cefixima(8 mg/kg/día,VO cada 24 horas)por 4 días más.Conclusiones.Los niños con neutropenia y fiebre de causa hemato-oncológica individualizados correctamente como de bajo riesgo pueden recibir inicialmente ceftriaxoma y amikacina durante 3 días y luego completar el tratamiento con 4 días más de cefixima por vía oral con buena eficacia y seguridad
Subject(s)
Child, Preschool , Child , Ceftriaxone/administration & dosage , Cefixime/administration & dosage , Neutropenia , Fever/therapy , Administration, Oral , Leukemia , PediatricsABSTRACT
Introducción.Para el tratamiento parenteral-oral con ceftriaxona y amikacina seguido de cefixima en niños con neutropenia y fiebre de causa hemato-oncológica,se realizó un estudio prospectivo entre los meses de mayo de 1997 y noviembre de 1999.Métodos.Durante dicho período fueron incluidos 101 episodios de neutropenia(neutrófilos menor 500/mm3 o recuento entre 500 y 1000/mmm3 y caida mayor 25 por ciento en la última semana)y fiebre(un pico febril >38,5 grados C o dos >38,1 grados C)en niños con enfermedad hemato-oncológica de bajo riesgo.Se definió al paciente de bajo riesgo como aquél que no presentaba signos severos de cormobilidad asociados(sangrados incoercibles,trastornos metabólicos refractarios al tratamiento,insuficiencia renal,hepática o respiratoria)mala condición clínica,predicción de padecer neutropenia más de 10 días no celulitis(de boca,periné,sobre el catéter)enteritis o mucositis severa.Todos los pacientes recibieron ceftriaxona(100 mg/kg/día,EV cada 24 horas)junto a amikacina(15mg/kg/día,EV cada 24 horas)durante 3 días,seguido de cefixima(8 mg/kg/día,VO cada 24 horas)por 4 días más.Conclusiones.Los niños con neutropenia y fiebre de causa hemato-oncológica individualizados correctamente como de bajo riesgo pueden recibir inicialmente ceftriaxoma y amikacina durante 3 días y luego completar el tratamiento con 4 días más de cefixima por vía oral con buena eficacia y seguridad
Subject(s)
Child, Preschool , Child , Administration, Oral , Cefixime/administration & dosage , Ceftriaxone/administration & dosage , Fever/therapy , Leukemia , Neutropenia , PediatricsABSTRACT
BACKGROUND: Febrile neutropenia is a heterogeneous condition. Recently, several risk factors have been defined, permitting the definition of a lower risk group of patients who may benefit form less aggressive therapy. The use of an oral antibiotic approach was tested in the current trial. METHODS: From May 1997 to March 1998, 154 episodes of lower risk febrile neutropenia in 128 children with a mean age of 62 (range, 8-200) months were enrolled in this randomized, single-institution trial. Inclusion criteria were fever (> 38 degrees C), neutropenia (absolute neutrophil count < 500/mm(3)), lower risk features (i.e., absence of severe comorbidity factors, good clinical condition, negative blood cultures, control of local infection, no fever during the last 24 hours), and compliance of parents. After 3 days of ceftriaxone (100 mg/kg/day administered intravenously [i.v.]) every 12 hours plus amikacin (15 mg/kg/day i.v.) every 24 hours for 3 days, all patients were discharged and randomized to be allocated to 2 treatment arms. Group A (n = 74) received ceftriaxone cefixime (8 mg/kg/day administered orally) every 24 hours for 4 days, whereas Group B (n = 80) was treated with ceftriaxone plus amikacin for 7 days. Failure was defined as the need for second hospitalization during the same episode of neutropenia, or fever during the 7 days after discharge. RESULTS: Most of the patients (49% in Group A and 55% in Group B) had acute leukemia. Fifty-four (72%) children in Group A and 46 (56%) in Group B had fever of unknown origin (P = not significant [NS]). No significant differences were found in the sites of initial infection between the two groups. Overall results were outstanding, with a favorable outcome in 73 of 78 cases (98.6%) in Group A and 78 of 80 cases (97.5%) in Group B (P = NS). Three patients needed a second hospitalization due to failure of the initial therapy: one in Group A and two in Group B. All three did well with secondary treatment. CONCLUSIONS: In lower risk febrile neutropenic children receiving anticancer therapy, the efficacy of oral cefixime, given for 4 days after 72 hours of intravenous ceftriaxone plus amikacin, was similar to that of 7 days of parenteral ceftriaxone plus amikacin. The oral outpatient therapy approach to the treatment of lower risk febrile neutropenia after chemotherapy is safe and may be cost-saving. This strategy might be adopted as standard therapy in the future.