Treating Parents to Reduce NICU Transmission of Staphylococcus Aureus Trial

Study Overview
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Brief Summary
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This trial will test the hypothesis that treating parents of neonates requiring NICU care with intranasal mupirocin and topical chlorhexidine bathing will reduce the spread of S. aureus from parents to neonates.

Detailed Description
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The TREAT PARENTS Trial, or Treating Parents to Reduce NICU Transmission of S. aureus, is a placebo-controlled, double-masked, randomized clinical trial to test the hypothesis that treatment of S. aureus colonized parents with intranasal mupirocin and topical chlorhexidine gluconate antisepsis will decrease neonatal S. aureus acquisition. All neonates admitted to the Johns Hopkins Hospital and Johns Hopkins Bayview Medical Center NICUs will be pre-screened and parents will be approached for enrollment in the study. After consent and baseline screening, 400 neonate-parent pairs will be randomized; only neonates who have a parent colonized with S. aureus will be randomized. Parents will receive a 5 day treatment with intranasal mupirocin plus topical chlorhexidine gluconate antisepsis or placebo. After recruitment and informed consent, parents will undergo pre-randomization screening. If both parents screen negative for S. aureus colonization, the neonate will be ineligible for the randomization and parents will be informed that the parents are not colonized at that time with S. aureus. If either parent screens positive for S. aureus, then both parents as a pair will be eligible for randomization to one of the two possible masked treatment arms. The neonate-parent pair will be the unit of randomization and each parent will be allocated to the same group if both consent. After the baseline neonate testing for S. aureus colonization, repeat testing will be performed every 7 days for the neonates until the neonate acquires S. aureus colonization or is discharged from the NICU.

Official Title
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Treating Parents to Reduce Neonatal Intensive Care Unit (NICU) Transmission of Staphylococcus Aureus

Conditions
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Staph Aureus Colonization, Staph Aureus Infection

Intervention / Treatment
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* Drug: Mupirocin and Chlorhexidine
* Drug: Placebo ointment and placebo cloths


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mupirocin and Chlorhexidine<br>Participants will apply 2% intranasal mupirocin twice a day for five days and cleanse with 2% chlorhexidine cloths once a day for five days. | Drug: Mupirocin and Chlorhexidine<br> <br> * Other names: chlorhexidine gluconate;|
| Placebo Comparator: Placebo ointment and placebo cloths<br>Participants will apply 2% petrolatum intranasal placebo ointment twice a day for five days and cleanse with 2% non-medicated soap placebo cloths once a day for five days. | Drug: Placebo ointment and placebo cloths<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Neonatal Infections With a S. Aureus Strain That is Concordant to Parental S. Aureus Strain | Primary outcome is neonatal acquisition of S. aureus strain that is concordant to parental S. aureus strain as determined by periodic surveillance cultures or a culture collected during routine clinical care that grows S. aureus. Survival analysis techniques will be used to compare the hazard of concordant colonization comparing Treatment and Control Groups. | Up to 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Staphylococcus aureus, Infection, Colonization, Transmission, Neonate