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Published on: July 18, 2017
Antibiotic treatment for pyelonephritis in children: multicentre randomised controlled non-inferiority trial
Giovanni Montini1, Antonella Toffolo, Pietro Zucchetta
1Nephrology, Dialysis, and Transplant Unit, Paediatric Department, Azienda Ospedaliera-University of Padua, 35128 Padua, Italy. montini@pediatria.unipd.it
Insights
Oral antibiotic treatment is as effective as parenteral followed by oral antibiotics for children experiencing their first episode of acute pyelonephritis. This finding simplifies treatment protocols for pediatric kidney infections.
Area of Science:
- Pediatric infectious diseases
- Nephrology
- Clinical pharmacology
Background:
- Acute pyelonephritis is a common serious bacterial infection in children.
- Current treatment guidelines often involve parenteral antibiotics, particularly for initial management.
- The need for effective and convenient treatment strategies is ongoing.
Purpose of the Study:
- To compare the efficacy of oral antibiotic therapy alone versus parenteral followed by oral therapy for children with a first episode of acute pyelonephritis.
- To determine if oral-only treatment is non-inferior to a parenteral-oral approach in preventing renal scarring and achieving clinical resolution.
Main Methods:
- A multicentre, randomized controlled, open-label, non-inferiority trial involving 502 children aged 1 month to 7 years with clinical pyelonephritis.
- Participants received either oral co-amoxiclav for 10 days or intravenous ceftriaxone for 3 days followed by oral co-amoxiclav for 7 days.
- Primary outcome was renal scarring assessed by dimercaptosuccinic acid (DMSA) scintigraphy at 12 months; secondary outcomes included time to defervescence and sterile urine at 72 hours.
Main Results:
- No significant differences were observed between the oral and parenteral-oral groups in the primary outcome of renal scarring (13.7% vs 17.7%).
- Secondary efficacy measures, including time to defervescence and sterile urine rates, also showed no significant differences between the treatment arms.
- Results were consistent in a subgroup analysis of children with confirmed pyelonephritis via DMSA scintigraphy at study entry.
Conclusions:
- Oral antibiotic treatment alone is as effective as parenteral followed by oral antibiotic treatment for the first episode of acute pyelonephritis in children.
- This suggests that oral-only antibiotic regimens can be considered a viable and effective management strategy, potentially simplifying care.
Objective:
To compare the efficacy of oral antibiotic treatment alone with treatment started parenterally and completed orally in children with a first episode of acute pyelonephritis.
Design:
Multicentre, randomised controlled, open labelled, parallel group, non-inferiority trial.
Setting:
28 paediatric units in north east Italy.
Participants:
502 children aged 1 month to <7 years with clinical pyelonephritis.
Intervention:
Oral co-amoxiclav (50 mg/kg/day in three doses for 10 days) or parenteral ceftriaxone (50 mg/kg/day in a single parenteral dose) for three days, followed by oral co-amoxiclav (50 mg/kg/day in three divided doses for seven days). Main outcomes measures Primary outcome was the rate of renal scarring. Secondary measures of efficacy were time to defervescence (<37 degrees C), reduction in inflammatory indices, and percentage with sterile urine after 72 hours. An exploratory subgroup analysis was conducted in the children in whom pyelonephritis was confirmed by dimercaptosuccinic acid (DMSA) scintigraphy within 10 days after study entry.
Results:
Intention to treat analysis showed no significant differences between oral (n=244) and parenteral (n=258) treatment, both in the primary outcome (scarring scintigraphy at 12 months 27/197 (13.7%) v 36/203 (17.7%), difference in risk -4%, 95% confidence interval -11.1% to 3.1%) and secondary outcomes (time to defervescence 36.9 hours (SD 19.7) v 34.3 hours (SD 20), mean difference 2.6 (-0.9 to 6.0); white cell count 9.8x10(9)/l (SD 3.5) v 9.5x10(9)/l (SD 3.1), mean difference 0.3 (-0.3 to 0.9); percentage with sterile urine 185/186 v 203/204, risk difference -0.05% (-1.5% to 1.4%)). Similar results were found in the subgroup of 278 children with confirmed acute pyelonephritis on scintigraphy at study entry.
Conclusions:
Treatment with oral antibiotics is as effective as parenteral then oral treatment in the management of the first episode of clinical pyelonephritis in children.
Trial Registration:
Clinical Trials NCT00161330 [ClinicalTrials.gov].
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