OBJECTIVE: To determine whether the addition of a single dose of ceftriaxone sodium to a 10-day course of trimethoprim and sulfamethoxazole hastens urine sterilization or resolution of clinical symptoms in febrile children with urinary tract infections. DESIGN: Prospective, single-blind, randomized study. SETTING:Tertiary care children's hospital emergency department. PATIENTS: Febrile children aged 6 months to 12 years with a presumptive urinary tract infection based on history, physical examination, and urinalysis findings. INTERVENTIONS: A history was taken, a physical examination and urinalysis and culture were performed, and a white blood cell count and erythrocyte sedimentation rate were obtained. Children were randomized to receive an intramuscular dose of ceftriaxone then 10 days of trimethoprim-sulfamethoxazole (IM + PO group) or oral trimethoprim-sulfamethoxazole alone (PO group). After receiving study medication, patients were discharged from the hospital to return in 48 hours for a follow-up evaluation and urine culture. Treatment failure was defined as the persistence of a positive culture at 48 hours or the need for hospital admission for intravenous rehydration or antibiotic therapy. RESULTS:Sixty-nine children were enrolled, 34 in the IM + PO group and 35 in the PO group. The 2 groups were similar at the initial visit with respect to age, sex, clinical degrees of illness, white blood cell count, and erythrocyte sedimentation rate (P>.05). At the 48-hour follow-up visit, there were no differences between the 2 treatment groups in resolution of vomiting, fever, general appearance, abdominal tenderness, and hydration state (P>.05). There were 9 treatment failures, 4 in the IM + PO group and 5 in the PO group (P =.93). CONCLUSION: The addition of a single dose of intramuscular ceftriaxone to a 10-day course of oral trimethoprim-sulfamethoxazole for urinary tract infection with fever resulted in no difference at 48 hours in the urine sterilization rate, degree of clinical improvement, or subsequent hospital admission rate.
RCT Entities:
OBJECTIVE: To determine whether the addition of a single dose of ceftriaxone sodium to a 10-day course of trimethoprim and sulfamethoxazole hastens urine sterilization or resolution of clinical symptoms in febrile children with urinary tract infections. DESIGN: Prospective, single-blind, randomized study. SETTING: Tertiary care children's hospital emergency department. PATIENTS: Febrile children aged 6 months to 12 years with a presumptive urinary tract infection based on history, physical examination, and urinalysis findings. INTERVENTIONS: A history was taken, a physical examination and urinalysis and culture were performed, and a white blood cell count and erythrocyte sedimentation rate were obtained. Children were randomized to receive an intramuscular dose of ceftriaxone then 10 days of trimethoprim-sulfamethoxazole (IM + PO group) or oral trimethoprim-sulfamethoxazole alone (PO group). After receiving study medication, patients were discharged from the hospital to return in 48 hours for a follow-up evaluation and urine culture. Treatment failure was defined as the persistence of a positive culture at 48 hours or the need for hospital admission for intravenous rehydration or antibiotic therapy. RESULTS: Sixty-nine children were enrolled, 34 in the IM + PO group and 35 in the PO group. The 2 groups were similar at the initial visit with respect to age, sex, clinical degrees of illness, white blood cell count, and erythrocyte sedimentation rate (P>.05). At the 48-hour follow-up visit, there were no differences between the 2 treatment groups in resolution of vomiting, fever, general appearance, abdominal tenderness, and hydration state (P>.05). There were 9 treatment failures, 4 in the IM + PO group and 5 in the PO group (P =.93). CONCLUSION: The addition of a single dose of intramuscular ceftriaxone to a 10-day course of oral trimethoprim-sulfamethoxazole for urinary tract infection with fever resulted in no difference at 48 hours in the urine sterilization rate, degree of clinical improvement, or subsequent hospital admission rate.