July 1996
WASHINGTON, D.C. — Oral treatment for suspected acute pyelonephritis (APN) in young febrile children may be as good as intravenous treatment, according to preliminary data from an ongoing study which was presented here.
The study compares oral cefixime (Suprax, Lederle) with intravenous (IV) cefotaxime (Claforan, Hoechst-Roussel) in children 1 month to 24 months old. Investigators have found the therapies equally efficacious in treating urinary tract infections (UTIs) as determined by the comparative development of renal scarring six months after starting treatment.
The finding could benefit young children. "Outpatient management may be less traumatic psychologically to the child, less disruptive to the family, and less likely to be associated with nosocomial infection," lead investigator Alejandro Hoberman, MD, told colleagues at the recent Pediatric Academic Societies' annual meeting here.
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Hoberman, who presented data on 192 children, also pointed to the cost savings that would result from keeping children aged 1 month to 24 months out of the hospital. "Given that UTI is the most frequently occurring serious bacterial infection in this age group, large savings in health care expenditures are possible," said Hoberman, who is an assistant professor of pediatrics at the University of Pittsburgh.
For the study, which was funded by the Children's Hospital of Pittsburgh and Wyeth-Lederle Laboratories, investigators randomly assign febrile children with UTI to receive oral cefixime for 14 days or IV cefotaxime for three days followed by oral cefixime for 11 days. Children need to have a rectal temperature of at least 38.3° C, pyuria (10 white blood cells or more per cubic millimeter) and a positive urine culture (50,000 or more colony forming units per milliliter) with a gram-negative enteric pathogen.
For each patient, investigators obtain a urinalysis, urine and blood cultures, and a DMSA scan at entry. To monitor clinical response, the investigators obtain a urine culture 24 hours after treatment starts and make inpatient visits or outpatient telephone calls at 48 hours and 72 hours. Investigators have patients return for a follow-up visit 14 days after initiation of treatment and telephone parents every two weeks to identify recurrences. Investigators obtain a follow-up urine culture at three and six months and a follow-up DMSA scan at six months to look for renal scarring.
Of the 192 children for whom investigators presented findings, 93 were in the oral treatment group and 99 were in the IV treatment group. Entry DMSA scans showed that 148 (77%) had APN, 43 (22%) had normal scans and one had a scan that could not be interpreted.
Of the 148 children with APN, 121 have completed the study. Forty-eight (40%) of these children had renal scarring at six months. Renal scarring occurred in 29.7% of children in the oral treatment group and 32.1% of children in the IV treatment group, a statistically insignificant difference. None of 33 children who had normal DMSA scans at entry and who have completed the study had renal scarring at six months.
Compared with children who had normal renal scans, patients with abnormal renal scans had significantly higher white blood cell counts, erythrocyte sedimentation rates, and levels of C-reactive protein. The most identified pathogens was Escherichia coli. All isolates were sensitive to third-generation cephalosporins.
Three patients in the oral treatment group and seven in the IV treatment group had bacteremia. All patients in both groups had sterile urine cultures within 24 hours of the start of treatment.
Both treatment arms had similar mean defervescence times: 26 hours for the oral treatment group and 24.8 hours for the IV treatment group. Five children in the oral treatment group had reinfection, compared with 11 in the IV treatment group, a difference that was not statistically significant.
For more information, see:
- Hoberman A, Wald ER, Reynolds EA, et al. Oral vs intravenous therapy for acute pyelonephritis in children 1-24 months. Abstract 787. Presented at the Pediatric Academic Societies' 1996 annual meeting, May 6-10, Washington, D.C.
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