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:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-24 @ 6:44 PM
NCT ID:
NCT05618457
Eligibility Criteria:
1. Adult patients (≥18yr)
2. Any infection treated with IV gentamycin or amikacin and approved by the consultant infectious diseases specialist, excluding neurosurgical infections, pneumonia, endocarditis or endovascular infections
3. Normal renal function or mild renal impairment (eGFR≥40ml/min)
4. On extended-interval AG and an expected remaining AG course of at least 4 days
5. At least one microbiological specimen with identification of an AG-susceptible pathogen and MIC determination and
6. Signed informed consent form
Exclusion Criteria:
1. Age\<18yr
2. Neurosurgical infections, pneumonia, endocarditis or endovascular infections
3. eGFR\<40ml/min
4. Empirical aminoglycoside treatment
5. Non Gram-negative pathogen
6. No MIC available for the pathogen
7. Expected remaining treatment duration of less than 4 days
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05618457
Study Brief:
Protocol Section:
NCT05618457