PYELOCOURT - 3-day intravenous antibiotic treatment versus 3-day intravenous followed by 7-day oral antibiotic treatment for acute pyelonephritis in children 1 month to 3 years old: a non-inferiority open randomized multicentric clinical trial

Conditions

acute pyelonephritis (AP) in children

Brief summary

The primary endpoint isrecurrence of febrile urinary tract infection within a 28 days period after the end completion of antibiotic treatment respectively at D31 (+/- 3 days) for the experimental group and D38 (+/- 3 days) for the control group.

Detailed description

Clinical cure 7 days after end of treatment, defined by apyrexia AND absence of signs suggestive of urinary infection (abdominal pain, urinary function signs) AND no feeding problem collected during a medical visit, respectively at D10 (+/- 3 days) for the experimental group and D17 (+/- 3 days) for the control group., Recurrent of AP within 90 days after the beginning of therapy (day 90 ± 15 days) collected during a phone call., Colonization with antimicrobial resistant Enterobacteriaceae in the gastrointestinal tract at days of randomization and at D10 (+/- 3 days) for the experimental group and D17 (+/- 3 days) for the control group, Alpha-diversity measured by Shannon’s index at inclusion, randomization, and at D10 (+/- 3 days) and D31 (+/- 3 days) for the experimental group, and D17 (+/- 3 days) and D38 (+/- 3 days) for the control group .

Related papers

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Interventions

DRUGCEFTRIAXONE

DRUGCEFIXIME

DRUGSULFAMETHOXAZOLE AND TRIMETHOPRIM

DRUGAMIKACIN

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
The primary endpoint isrecurrence of febrile urinary tract infection within a 28 days period after the end completion of antibiotic treatment respectively at D31 (+/- 3 days) for the experimental group and D38 (+/- 3 days) for the control group.	—

Secondary

Measure	Time frame
Clinical cure 7 days after end of treatment, defined by apyrexia AND absence of signs suggestive of urinary infection (abdominal pain, urinary function signs) AND no feeding problem collected during a medical visit, respectively at D10 (+/- 3 days) for the experimental group and D17 (+/- 3 days) for the control group., Recurrent of AP within 90 days after the beginning of therapy (day 90 ± 15 days) collected during a phone call., Colonization with antimicrobial resistant Enterobacteriaceae in the gastrointestinal tract at days of randomization and at D10 (+/- 3 days) for the experimental group and D17 (+/- 3 days) for the control group, Alpha-diversity measured by Shannon’s index at inclusion, randomization, and at D10 (+/- 3 days) and D31 (+/- 3 days) for the experimental group, and D17 (+/- 3 days) and D38 (+/- 3 days) for the control group .	—

Measure

Time frame

Clinical cure 7 days after end of treatment, defined by apyrexia AND absence of signs suggestive of urinary infection (abdominal pain, urinary function signs) AND no feeding problem collected during a medical visit, respectively at D10 (+/- 3 days) for the experimental group and D17 (+/- 3 days) for the control group., Recurrent of AP within 90 days after the beginning of therapy (day 90 ± 15 days) collected during a phone call., Colonization with antimicrobial resistant Enterobacteriaceae in the gastrointestinal tract at days of randomization and at D10 (+/- 3 days) for the experimental group and D17 (+/- 3 days) for the control group, Alpha-diversity measured by Shannon’s index at inclusion, randomization, and at D10 (+/- 3 days) and D31 (+/- 3 days) for the experimental group, and D17 (+/- 3 days) and D38 (+/- 3 days) for the control group .

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Countries

France

Outcome results

None listed