3-day IV Antibiotic Treatment Versus 3-day IV Followed by 7-day Oral Antibiotic Treatment for AP … (NCT05544565) | Clinical Trial Compass
RecruitingPhase 4
3-day IV Antibiotic Treatment Versus 3-day IV Followed by 7-day Oral Antibiotic Treatment for AP in Children
France480 participantsStarted 2023-03-22
Plain-language summary
Antibiotic therapies currently recommended for the treatment of acute pyelonephritis (AP) in children, whether fully by the oral route or initially intravenous (IV, 3 days) followed by the oral route, have a duration of 7 to 14 days (10 days in France).
In children with no prior urological malformation, the global clinical and microbiological cure rate after antibiotic treatment completion is around 95%. Recurrence occurs in less than 5% of cases in the 3 months following AP. Renal scarring, when documented, concerns 15% of children 6 months after treatment. Renal scarring can be associated with chronic renal disease.
The investigators hypothesize that 3 days of IV treatment is equivalent to extending to 10 days with an oral to treat AP in children.
The investigators also hypothesize that while achieving equivalent clinical and prevention of re-infections in the following 3 months, 3 days of IV treatment reduces the risk of acquisition of resistant strains of Enterobacteriaceae and increases the gut microbotia diversity compared to extending to 10 days with an oral therapy.
Who can participate
Age range1 Month – 3 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 1 month and \< 3 years
* For children younger than 3 months, gestational age \> 34 WA
* First episode of urinary tract infection
* AP defined by temperature ≥ 38°C on day of diagnosis AND positive urinalysis (white cell counts ≥ 10\^4/mL) with a positive urine culture with one Gram- negative bacillus ≥ 104 UFC/mL. The child temperature will have to be measured with a thermometer according to the French national recommendations \[Health Insurance website (AMELI ;see: - https://www.ameli. fr/assure/sante/bons-gestes/soins/prendre-temperature); HAS (see: https://www.has-sante. fr/jcms/c\_2674284/fr/prise-en-charge-de-la-fievre-chez-l-enfant)\].
* Initial treatment by either ceftriaxone AND/OR amikacin
* Outpatient or hospitalised
Non-inclusion Criteria:
* Urine collected by bag
* Urine culture growing more than one dominant bacterium (cf section 6.2 of the protocol)
* Catheter-associated acute pyelonephritis
* Known congenital anomalies of the kidney and genitourinary tract (other than vesicoureteral reflux and pyelocaliceal dilatation \< 10 mm)
* Previous surgery of the genitourinary tract (except circumcision in male children)
* Abnormal renal function for age and weight (defined by a serum creatinine \>40µmol/L before 1 year and \>75µmol between 1 year et 3 years)
* Known immunocompromising condition (e.g., HIV, primary immunodeficiency, sickle cell disease, use of chronic corticosteroids or other immunosuppressive agents)
* Antibiotic prophylax…
What they're measuring
1
Recurrence of febrile urinary tract infection
Timeframe: 28 days (± 3 days) after the completion of antibiotic treatment.