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 @ 4:28 AM
Ignite Modification Date:
2025-12-25 @ 4:28 AM
NCT ID:
NCT02223520
Eligibility Criteria:
Inclusion Criteria:
* Neonate has never had a clinical or surveillance culture grow S. aureus
* Neonate was transferred from another hospital or admitted from home and had admission screening cultures for S. aureus colonization that were negative (if admission cultures were not performed, the cultures will be performed as part of the pre-randomization screening process)
* Parent(s) is(are) able to visit the child at the bedside
* Parent(s) test positive for S. aureus at screening
* Neonate has anticipated stay longer than 5 days in the NICU (if estimated stay is unclear, parents can be screened for S. aureus colonization and decision to randomize can be delayed until hospital day 3 or 4 after reassessment of anticipated stay).
* Parents is(are) willing to be randomized
* No documented or reported allergies to any agent used in either treatment regimen
* Able to perform written informed consent
Exclusion Criteria:
* Allergies to any agent used in either treatment regimen
* Neonate has had a prior clinical or surveillance culture grow S. aureus
* Neonate admitted to NICU from home and is greater than 7 days of age
* Neonate admitted to NICU from another hospital and is greater than 7 days of age
* Neonate is a ward of the State
* Not able to provide written informed consent
Healthy Volunteers:
True
Sex:
ALL
Study:
NCT02223520
Study Brief:
Protocol Section:
NCT02223520