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 @ 6:43 PM
Ignite Modification Date:
2025-12-24 @ 6:43 PM
NCT ID:
NCT02966457
Eligibility Criteria:
Inclusion Criteria:
1. Microbiologically proven rectal carriage of ESBL-producing Enterobacteriaceae or carbapenem-resistant Enterobacteriaceae, A. baumannii, P. aeruginosa without signs and symptoms of active infection.
2. Patient must give written informed consent to participate in the study. The informed consent can be given by the legal representative if necessary.
Exclusion Criteria:
1. Active bacterial, viral, fungal or protozoal infection
2. Women who are pregnant or nursing
3. Antibacterial therapy in previous 10 days
4. Contraindication to the use of one of the study drugs (including known hypersensitivity)
5. Patient already enrolled in another study, or in the present study for a previous episode
6. Psychiatric disorder or unable to understand or to follow the protocol directions
7. Resistance of the primarily isolated colonizing microorganism to polymyxin antibiotics proven by methods of polymerase chain reaction
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02966457
Study Brief:
Protocol Section:
NCT02966457