Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-25 @ 4:03 AM
NCT ID:
NCT02260102
Eligibility Criteria:
Inclusion Criteria:
* patient requiring temocillin
1. for the treatment of urinary tract infections, or
2. for the treatment of suspicion of cholangitis associated with cirrhosis, or
3. as antibiotic prophylaxis following an hepatic transplant.
* patient requiring hospitalization (not for social or other non-medical reasons) for at least up to 5 days
* Parents or legal representatives able to give written informed consent in accordance with GCP and local regulatory requirements, prior to any study procedure
Exclusion Criteria:
1. Ig-E mediated allergy to penicillins
2. Previous treatment with temocillin for the current cholangitis episode
3. Diagnosis of Alagille syndrome
4. Estimated life-expectance of \< 5 days due to major co-morbid conditions
5. Other serious illnesses, e.g. HIV, serious infections requiring other antibiotics, malignancy
6. Patients with acute or chronic renal failure (eGFR \< 30ml/min)
7. Patients having participated in another study \< 30 days before inclusion in the present study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
3 Years
Study:
NCT02260102
Study Brief:
Protocol Section:
NCT02260102