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 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 12:39 AM
NCT ID:
NCT03725267
Eligibility Criteria:
Inclusion Criteria:
1. Treatment with polymyxin B ( a second inclusion will be accepted if the end of the previous treatment was more than 30-days before enrollment)
2. Agreement with the consent form
Exclusion Criteria:
1. Suspension of polymyxin B therapy with \<48hs
2. Death in \<48hs
3. Dialysis or Glomerular Filtration Rate (GFR) \<10 ml/min at the beginning of treatment by the Modification in Diet in Renal Disease (MDRD) formula
4. Lactose intolerance
5. ICU admission at the beginning of therapy
6. Previous regular use of Melatonin
7. Pregnancy
8. Patients deprived from liberty
9. Unability to receive oral medication (i.e total parenteral nutrition)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03725267
Study Brief:
Protocol Section:
NCT03725267