3-day IV Antibiotic Treatment Versus 3-day IV Followed by 7-day Oral Antibiotic Treatment for AP in Children
Condition(s) studied
Investigational drug(s) / intervention(s)
IV Antibacterial Agents: Ceftriaxone (50 mg/kg once a day by intravenous/intramuscular route) AND/OR Amikacin (20 mg/kg once a day by intravenous/intramuscular route) during 3 days. .
Orally antibacterial agents: Cotrimoxazole (sulfamethoxazole/trimethoprime) 30mg/kg/day (2 divided doses) OR Cefixime 8mg/kg/day (2 divided doses) during 7 days
Fecal/Rectal Swab: Collected by the nurse or the physician (D0,D3,D10 or 17 and D31 or D38), either by a rectal swab, either by fecal swab (dip of the swab in fresh stools \< 4 hours, which will occur frequently in our population of children aged 1 month to 3 years, and will in particular be possible for hospitalized children) using a FecalSwabTM, that contains a transport medium.
PCT assay: Dosage of procalcitonin (if not performed in standard care) at D0
Study 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.
Eligibility
Primary outcome measure(s)
- Recurrence of febrile urinary tract infection — 28 days (± 3 days) after the completion of antibiotic treatment.
Demonstrate the non-inferiority of a 3-day intravenous (IV) antibiotic therapy versus a 3-day IV therapy followed by a 7-day oral antibiotic therapy for the treatment of AP in children in term of the is recurrence of febrile urinary tract infection within a 28 -days period after the completion of antibiotic treatment respectively at D31 (+/- 3 days) for the experimental group and D38 (+/- 3 days) for the control group.. The recurrence will be defined as: fever ≥ 38°C associated with a positive urinalysis (white cell counts ≥ 10\^4/mL) with a positive urine culture with one Gram-negative bacillus ≥ 10\^4 UFC/mL
Trial sites (15)
| Facility | City | Region | Status |
|---|---|---|---|
| CH Sud Francilien | Corbeil-Essonnes | Essonne | Not Yet Recruiting |
| Paris-Saclay hospital | Orsay | Essonne | Recruiting |
| Antoine Beclère Hospital | Clamart | Haut de Seine | Not Yet Recruiting |
| Ambroise Paré hospital | Boulogne | Hauts de Seine | Recruiting |
| Children-Teenager hospital | Nantes | Loire Atlantique | Not Yet Recruiting |
| Jeanne Flandre Hospital | Lille | Nord | Not Yet Recruiting |
| Robert Debré Hospital | Paris | Paris | Not Yet Recruiting |
| Robert Debré Hospital | Paris | Paris | Not Yet Recruiting |
| Meaux Hospital | Meaux | Seine et Marne | Not Yet Recruiting |
| Jean Verdier Hospital | Bondy | Seine St Denis | Not Yet Recruiting |
| Intercomunal Créteil Hospital | Créteil | Val de Marne | Not Yet Recruiting |
| Kremlin Bicêtre Hospital | Le Kremlin-Bicêtre | Val de Marne | Not Yet Recruiting |
| Andre mignot hospital | Le Chesnay | Yvelines | Recruiting |
| GHEF Site Marne la vallée | Jossigny | France | Not Yet Recruiting |
| CHU Toulouse | Toulouse | France | Not Yet Recruiting |
More Assistance Publique - Hôpitaux de Paris trials in France
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05544565 on ClinicalTrials.gov ↗ ← All trials in France