3-day IV Antibiotic Treatment Versus 3-day IV Followed by 7-day Oral Antibiotic Treatment for AP in Children

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.

Conditions

• Pyelonephritis Acute

Interventions

DRUG

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. .

DRUG

Orally antibacterial agents

Cotrimoxazole (sulfamethoxazole/trimethoprime) 30mg/kg/day (2 divided doses) OR Cefixime 8mg/kg/day (2 divided doses) during 7 days

PROCEDURE

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.

PROCEDURE

PCT assay

Dosage of procalcitonin (if not performed in standard care) at D0

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris

  lead OTHER

Principal Investigators

• Jean GASCHIGNARD, PhD · Hôpital Paris-Saclay

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Month

Max Age

3 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-03-22

Primary Completion

2028-01-31

Completion

2028-01-31

Countries

• France

Study Locations