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

Status: Recruiting
Location: See all (15) locations...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 3
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Jean Verdier Hospital
NOT_YET_RECRUITING
Bondy
Ambroise Paré hospital
RECRUITING
Boulogne
Antoine Beclère Hospital
NOT_YET_RECRUITING
Clamart
CH Sud Francilien
NOT_YET_RECRUITING
Corbeil-essonnes
Intercomunal Créteil Hospital
NOT_YET_RECRUITING
Créteil
GHEF Site Marne la vallée
NOT_YET_RECRUITING
Jossigny
Andre mignot hospital
RECRUITING
Le Chesnay
Kremlin Bicêtre Hospital
NOT_YET_RECRUITING
Le Kremlin-bicêtre
Jeanne Flandre Hospital
NOT_YET_RECRUITING
Lille
Meaux Hospital
NOT_YET_RECRUITING
Meaux
Children-Teenager hospital
NOT_YET_RECRUITING
Nantes
Paris-Saclay hospital
RECRUITING
Orsay
Robert Debré Hospital
NOT_YET_RECRUITING
Paris
Robert Debré Hospital
NOT_YET_RECRUITING
Paris
CHU Toulouse
NOT_YET_RECRUITING
Toulouse
Contact Information
Primary
Jean GASCHIGNARD, PhD
j.gaschignard@ghne.fr
+33 1 69 15 96 00
Backup
Romain BASMACI, PhD
romain.basmaci@aphp.fr
+33 1 47 60 63 58
Time Frame
Start Date: 2023-03-22
Estimated Completion Date: 2028-01
Participants
Target number of participants: 480
Treatments
Experimental: Experimental group: Discontinuation of treatment
For patients randomized in the experimental group, the patient receives 3-day IV therapy and the treatment is interrupted.
Other: Control group: Usual practice
For patients randomized in the control group, the treatment for acute pyelonephritis is based on the attending clinician's practice and according to the usual practice: 3-day IV therapy followed by a 7-day oral antibiotic therapy.
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov