Measuring the concentration profile of the antibiotic temocillin in the blood of childre

Phase 1

• Conditions: Male or female patient requiring temocillin a. for the treatment of urinary tract infections, orb. for the treatment of suspicion of cholangitis associated with cirrhosis, orc. as antibiotic prophylaxis following an hepatic transplant.; MedDRA version: 18.1Level: PTClassification code 10024714Term: Liver transplantSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 18.1Level: HLTClassification code 10004607Term: Bile duct infections and inflammationsSystem Organ Class: 10019805 - Hepatobiliary disorders; MedDRA version: 18.1Level: SOCClassification code 10042613Term: Surgical and medical proceduresSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 18.1Level: PTClassification code 10046571Term: Urinary tract infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 18.1Level: HLGTClassification code 10021879Term: Infections - pathogen unspecifiedSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 18.1Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 18.1Level: HLTClassification code 10019704Term: Hepatic therapeutic proceduresSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 18.1Level: PTClassification code 10008605Term: Cholangitis acuteSystem Organ Class: 10019805 - Hepatobiliary disorders; MedDRA version: 18.1Level: SOCClassification code 10019805Term: Hepatobiliary disordersSystem Organ Class: 10019805 - Hepatobiliary disorders

• Registration Number: EUCTR2014-004224-22-BE
• Lead Sponsor: niversité catholique de Louvain

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-10
• Last Update Posted: 23 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Male or female patient requiring temocillin
a. for the treatment of urinary tract infections, or
b. for the treatment of suspicion of cholangitis associated with cirrhosis, or
c. as antibiotic prophylaxis following an hepatic transplant.
2. Requirement of hospitalization (not for social or other non-medical reasons) for at least up to 5 days
3. Patients aged 6 months - 3 years at the beginning of the treatment with temocillin
4. Parents or legal representatives able to give written informed consent in accordance with GCP and local regulatory requirements, prior to any study procedure

Are the trial subjects under 18? yes
Number of subjects for this age range: 45
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Ig-E mediated allergy to penicillins
2. Previous treatment with temocillin for the current cholangitis episode
3. Estimated life-expectancy of < 5 days due to major co-morbid conditions
4. Other serious illnesses (e.g. HIV), serious infections requiring other antibiotics, malignancy
5. Patients with acute or chronic renal failure (eGFR < 30ml/min)
6. Patients having participated in another study < 30 days before inclusion in the present study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified