Treating Parents to Reduce NICU Transmission of Staphylococcus Aureus Trial

NCT02223520 | Completed Results DMC

• 2 other identifiers: NA_00092982R01HS022872
• Study Type: interventional
• Target: 307
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Staph Aureus Colonization; Staph Aureus Infection

Keywords

Staphylococcus aureus; Infection; Colonization; Transmission; Neonate

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Mupirocin and Chlorhexidine

ACTIVE COMPARATOR

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

Placebo ointment and placebo cloths

PLACEBO COMPARATOR

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

Interventions

Mupirocin and Chlorhexidine DRUG

Also known as: bactroban, chlorhexidine gluconate

Mupirocin and Chlorhexidine

Placebo ointment and placebo cloths DRUG

Placebo ointment and placebo cloths

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (2)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (2)

• Milstone AM, Voskertchian A, Koontz DW, Khamash DF, Ross T, Aucott SW, Gilmore MM, Cosgrove SE, Carroll KC, Colantuoni E. Effect of Treating Parents Colonized With Staphylococcus aureus on Transmission to Neonates in the Intensive Care Unit: A Randomized Clinical Trial. JAMA. 2020 Jan 28;323(4):319-328. doi: 10.1001/jama.2019.20785.

  PMID: 31886828 DERIVED

• Milstone AM, Koontz DW, Voskertchian A, Popoola VO, Harrelson K, Ross T, Aucott SW, Gilmore MM, Carroll KC, Colantuoni E. Treating Parents to Reduce NICU Transmission of Staphylococcus aureus (TREAT PARENTS) trial: protocol of a multisite randomised, double-blind, placebo-controlled trial. BMJ Open. 2015 Sep 9;5(9):e009274. doi: 10.1136/bmjopen-2015-009274.

  PMID: 26353875 DERIVED

MeSH Terms

Conditions

Staphylococcal Infections; Infections

Interventions

Mupirocin; Chlorhexidine; chlorhexidine gluconate

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Epoxy Compounds; Ethers, Cyclic; Ethers; Organic Chemicals; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fatty Acids; Lipids; Biguanides; Guanidines; Amidines

Results Point of Contact

• Title: Aaron M. Milstone, M.D., M.H.S.
• Organization: Johns Hopkins Medical Institutions

amilsto1@jhmi.edu

410-614-3917

Study Officials

• Aaron Milstone, MD, MHS

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2014
• First Posted: August 22, 2014
• Study Start: November 1, 2014
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: January 11, 2022
• Results First Posted: March 16, 2020

Record last verified: 2020-03

Locations

US (2)