Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Jul 7, 2025
Trial Information
Current as of July 22, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how the antibiotic temocillin is processed in the bodies of children aged 0 to 15 who have a fever caused by a specific type of urinary tract infection (UTI) called pyelonephritis. Temocillin is a medicine used to treat infections caused by certain bacteria, but doctors don’t yet know the best dose for children. This study aims to find out how the drug behaves in children’s bodies, so doctors can recommend the right dose based on a child’s age and kidney function.
Children who have a fever and a confirmed urinary tract infection caused by certain bacteria, and who need to stay in the hospital for at least two days, may be able to join. Kids with severe infections like sepsis, allergies to similar antibiotics, or serious kidney problems won’t be eligible. If your child takes part, hospital staff will carefully monitor how their body handles the medicine to help improve treatment for future patients. This study is not yet open for participants but will take place at the Robert-Debré University Hospital.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Patient aged 0 to 15 years
- • Presenting with a febrile urinary tract infection due to GNR (a febrile urinary tract infection is defined as a urine culture showing significant leukocyturia (≥104) and direct examination showing GNR, in a patient with fever)
- • Requiring hospitalization in the general pediatrics, emergency (short-stay hospitalization unit), nephrology, or intensive care units of the Robert-Debré University Hospital for a presumed period of at least 48 hours.
- • Non-opposition of the legal representatives obtained by one of the investigator
- Exclusion Criteria:
- • Presence of sepsis (Phoenix score ≥ 2)
- • Gram-positive cocci (GPC) urinary tract infection (Urinalysis before antibiotic therapy revealed significant leukocyturia (≥104) and direct examination revealed GPC)
- • Known allergy to beta-lactam antibiotics
- • Severe renal impairment (glomerular filtration rate \<30 mL/min\*1.73 m2)
About Assistance Publique Hôpitaux De Paris
Assistance Publique - Hôpitaux de Paris (AP-HP) is a leading public hospital system in France, renowned for its commitment to healthcare excellence and innovative medical research. As a prominent clinical trial sponsor, AP-HP plays a pivotal role in advancing medical knowledge and improving patient care through rigorous scientific investigations across a wide range of therapeutic areas. With a focus on collaboration and interdisciplinary approaches, AP-HP leverages its extensive network of hospitals and expert clinicians to facilitate high-quality clinical trials that adhere to the highest ethical and regulatory standards, ultimately aiming to translate research findings into tangible health benefits for diverse patient populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Paris, , France
Patients applied
Trial Officials
Gabriel LIGNIERES, MD
Principal Investigator
Assistance Publique - Hôpitaux de Paris
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported