Treating Parents to Reduce NICU Transmission of Staphylococcus Aureus Trial

Staph Aureus Infection Clinical Trial

— TREAT PARENTS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02223520
• Other study ID #: NA_00092982
• Secondary ID: R01HS022872
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: October 31, 2019

Study information

• Verified date: March 2020
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 307
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Staph Aureus Colonization
• Staph Aureus Infection
• Staphylococcal Infections

Intervention

Drug:
• Mupirocin and Chlorhexidine

• Placebo ointment and placebo cloths

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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