Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children

NCT07070102 | Not Yet Recruiting

• 2 other identifiers: APHP2416842025-A00368-41
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Temocillin, a 6-alpha-methoxypenicillin derivative of ticarcillin, is a narrow-spectrum antibiotic, primarily restricted to Enterobacterales. Therefore, its prescription for the treatment of febrile urinary tract infections requiring hospitalization in pediatrics appears interesting. However, and despite marketing authorization in pediatrics for the treatment of complicated urinary tract infections (including acute pyelonephritis), the pharmacokinetic parameters of this antibiotic have not been specifically evaluated in pediatrics, and the optimal dose is not known in this population. Through this study, we propose to determine the pharmacokinetic parameters of temocillin in children aged 0-15 years with a febrile urinary tract infection due to Gram-negative rod (GNR), without sepsis but requiring hospitalization. The results will help to establish dose recommendations for temocillin in the pediatric population, based on age and renal function.

Conditions

Pyelonephritis

Keywords

temocillin

Outcome Measures

Primary Outcomes (1)

• Achievement of the theoretical PK/PD target of 40% of the time spent above the MIC of the bacteria in question (fT>MIC=40%) for a temocillin dose of 50mg/kg/day in 2 IV injections of 30 min spaced 12h apart,

  Achievement of the theoretical PK/PD target of 40% of the time spent above the MIC of the bacteria in question (fT\>MIC=40%) for a temocillin dose of 50mg/kg/day in 2 IV injections of 30 min spaced 12h apart, on the population modellisation of the unbound plasma concentration of temocillin over 24h. Samples taken 1 hour after the start of a temocillin infusion then between 6 and 8 hours after the start of the infusion or sample taken 2 hours after the start of a temocillin infusion then between 10 and 12 hours after the start of the infusion

  24 months

Interventions

blood samples OTHER

2 blood samples of 1 mL

Eligibility Criteria

• Age: 1 Day - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patient aged 0 to 15 years (inclusive) presenting with a febrile urinary tract infection with BGN requiring hospitalization in the departments of the Robert-Debré University Hospital for a duration of at least 48 hours

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Robert Debre Hospital

Paris, Ap-hp / DRCI, 75019, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

2 blood samples of 1 mL. The study is observational because participants get these blood samples as part of routine medical care.

MeSH Terms

Conditions

Pyelonephritis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Nephritis, Interstitial; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pyelitis; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Gabriel LIGNIERES, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriel LIGNIERES, MD

CONTACT

+331 40 03 53 61; GABRIEL.LIGNIERES@aphp.fr

Marion CASERIS, MD

CONTACT

+331 40 03 53 61; marion.caseris@aphp.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 17, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 17, 2025

Record last verified: 2025-06

Locations

FR (1)