3-day IV antibiotics versus 3-day IV followed by 7-day oral antibiotics for acute pyelonephritis in young children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Children aged 1 month to under 3 years with a first episode of acute pyelonephritis confirmed by fever and a positive urine culture will receive initial IV antibiotics (ceftriaxone and/or amikacin) for three days. After the initial IV period they will either stop antibiotic therapy or continue with a 7-day oral antibiotic course, with follow-up for clinical and microbiological outcomes. Outcomes include cure rates, recurrence within three months, renal scarring at six months, acquisition of resistant Enterobacteriaceae, and gut microbiota diversity. Microbiological samples (urine and fecal/rectal swabs) and PCT assays will be collected per protocol to measure these endpoints.

Why it matters

Who can join: the full rules

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 prophylaxis for any reason OR antibiotic treatment in the last 7 days (except treatment administered for the AP)
* Known hypersensitivity to at least one of the active substances /excipients: ceftriaxone (including other cephalosporins and other beta-lactams) and amikacin (including other aminoglycosids).
* Known hypersensitivity to at least one of the active substances /excipients: cotrimoxazole (=sulfamethoxazole/trimethoprim) (including other drugs containing sulfonamides) and cefixime (including other cephalosporins)
* Known blood dyscrasias (megaloblastic haematopoiesis)
* Known severe hepatic insufficiency
* Known G6PD deficiency
* No written consent from holders of parental authority
* Non-affiliation to a social security system (as beneficiary or entitled person)
* Children whose follow-up is not carried out in the centre
* Participation in another interventional or minimal risk trial

Randomization criteria :

* Three days of taking antibiotics (IV or IM) (no interruption or discontinuation)
* Positive urine culture with Gram negative bacillus ≥ 10\^4 UFC/mL
* Favorable clinical outcome at day of randomization (D2 or D3) defined by temperature \< 38°C at day of randomization and absence of fever measured \> 38°C for at least 12 hours AND no abdominal pain AND no feeding problem AND investigator agreement
* No renal abscess AND congenital anomalies of the kidney and genitourinary tract (other than vesicoureteral reflux and pyelocaliceal dilatation \< 10 mm) on the renal ultrasound performed between D0 and day of randomization
* No more than 1 type of dominant bacteria on the urine culture
* Sensitivity to the initial antibiotic treatment
* Sensitivity to cefixime OR cotrimoxazole

Where it's running

• Paris-Saclay hospital
  Orsay, Essonne, France Recruiting
• Ambroise Paré hospital
  Boulogne, Hauts de Seine, France Recruiting
• Andre mignot hospital
  Le Chesnay, Yvelines, France Recruiting
• CH Sud Francilien
  Corbeil-Essonnes, Essonne, France Not yet recruiting
• Antoine Beclère Hospital
  Clamart, Haut de Seine, France Not yet recruiting
• Children-Teenager hospital
  Nantes, Loire Atlantique, France Not yet recruiting

Study contacts

• Principal investigator: Jean GASCHIGNARD, PhD — Hôpital Paris-Saclay
• Study coordinator: Jean GASCHIGNARD, PhD
• Email: j.gaschignard@ghne.fr
• Phone: +33 1 69 15 96 00

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparing 7 days versus 14 days of antibiotics for kidney transplant patients with acute pyelonephritis

  This study is testing if kidney transplant patients with a certain type of kidney infection can be treated safely with just 7 days of antibiotics instead of the usual 14 days.

  Recruiting at 4 sites Phase 3 Assistance Publique - Hôpitaux de Paris · Bordeaux and 8 other locations · NCT05597540

• New quick MRI method for pediatric kidney disease

  This study is testing a new, faster MRI method for kids with kidney problems to see if it can better detect infections and damage without using radiation or injections.

  Recruiting University of Wisconsin, Madison · Madison, Wisconsin · NCT03959163

• Diagnosing abdominal pain with a six-RNA blood test

  This study will test whether a blood test that measures six RNA markers can help doctors determine if abdominal pain in people aged 7 and older is caused by infections such as appendicitis, diverticulitis, or pyelonephritis.

  Recruiting True Bearing Diagnostics, Inc. · Washington D.C., District of Columbia · NCT07579312

• Temocillin pharmacokinetics in kids with febrile urinary tract infection

  This study tests how temocillin behaves in the bodies of children aged 0-15 with febrile UTIs due to Gram-negative bacteria who need hospitalization.

  Recruiting Assistance Publique - Hôpitaux de Paris · Paris, Ap-hp / DRCI · NCT07070102

• Comparing oral and intravenous cefuroxime for treating pyelonephritis in pregnant women

  This study is testing whether taking cefuroxime by mouth is just as effective as getting it through an IV for treating kidney infections in pregnant women.

  Recruiting Phase 4 Hospital de Clinicas de Porto Alegre · Porto Alegre, Rio Grande do Sul · NCT06527560

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.