Bacterial Decolonization Within Dyads (BADMC)

Impact of Bacterial Decolonization on Bacterial Burden Within Maternal-infant Dyads

The goal of this study is to measure bacterial burden, specifically Staph aureus, and how it spreads between mothers and their infants. Researchers will evaluate if the amount of bacteria on their skin remains the same after mothers use a skin antisepsis treatment prior to delivering their infants. The investigators also aim to assess participant interest in and compliance with skin antisepsis treatments. The hypothesis is that increased maternal interest will align with increased treatment compliance.

Study Overview

• Status: Completed
• Conditions: Bacterial Colonization
• Intervention / Treatment: Drug: Mupirocin; Drug: Chlorhexidine baths

Detailed Description

Few studies have assessed the clinical epidemiology of bacterial transmission among mother-infant dyads in hospitalized and community settings. In an era of rising antimicrobial resistance, the epidemiology of colonization and infections are also changing. Maternal factors account for infants' early exposure to bacteria. Maternal colonization with multi-drug resistant (MDR) bacteria portends a high likelihood of transmission to the infant.

As methicillin resistant Staph aureus (S. aureus) bacteria remain among the top causes of pediatric infections, the presence of these species among mothers and infants can be used to assess antimicrobial resistance, colonization and transmission in maternal-infant dyads. S. aureus is a uniquely interesting pathogen in the perinatal period. MRSA nasal colonization is a sensitive predictor of bloodstream, genitourinary and respiratory infections. Also, parental colonization with S. aureus is typically concordant with infants' colonizing and infecting S. aureus strains. In tandem, there have been numerous studies assessing the utility and impact of MRSA decolonization for high risk patients. This project creates a unique opportunity for in-depth microbiological analyses of maternal-infant dyads.

Design & Procedures: S. aureus skin decolonization methods have been safely tolerated in adults and children. The investigators propose a combination of intranasal mupirocin and chlorhexidine baths for a 5-day decolonization treatment targeting pregnant women already consented to participate in a longitudinal cohort - Project HOPE cohort. The investigators will aim for maternal participation in their third trimester. The decolonization regimen will include:

1. Intranasal mupirocin - Participants will place a pea-sized amount (or approximately 1cm ribbon) of 2% mupirocin ointment on a cotton swab and gently massage it into the anterior nares twice daily for 5 days.
2. Chlorhexidine baths - Participants will be instructed to use pre-packaged chlorhexidine cloths. Each cloth will be used to wipe designated body areas (i.e., arms, legs, chest and neck, back and perineum) once a day for 5 days. These are inexpensive cloths that are easy to use and have been shown to be effective at eradicating Staph aureus carriage. Ideally, participants will be instructed not to rinse off immediately after using the cloths. Baths should be performed on the same 5 days as they apply the intranasal mupirocin.

Evaluation of decolonization protocol compliance: The investigators will provide verbal and printed instructions in participants' preferred languages (English or Spanish). The research team will conduct two weekly check-ins - one during the treatment week and the other during the subsequent week. The investigators will also conduct online surveys to gauge decolonization tolerance and self-reported completion rates. When plausible, participants will be asked to return the mupirocin tube at their next routinely scheduled visit to confirm appropriate use.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27703
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants must be enrolled in longitudinal study Project HOPE1000.

Exclusion Criteria:

• Participants not enrolled in Project HOPE1000 will be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Maternal Skin Decolonization; These decolonization methods have been safely tolerated in adults and children. We propose a combination of intranasal mupirocin and chlorhexidine baths for a 5-day decolonization regimen targeting pregnant women in their third trimester prior to delivery	Drug: Mupirocin; Participants will place a pea-sized amount (or approximately 1cm ribbon) of 2% mupirocin ointment (Duke formulary) on a cotton swab and gently massage it into the anterior nares twice daily for 5 days.; Other Names: Bactroban; Drug: Chlorhexidine baths; Participants will be instructed to use pre-packaged chlorhexidine cloths. Each cloth will be used to wipe designated body areas (i.e., arms, legs, chest and neck, back and perineum) once a day for 5 days. These are inexpensive cloths that are easy to use and have been shown to be effective at eradicating Staph aureus carriage. Ideally, participants will be instructed not to rinse off immediately after using the cloths. Baths should be performed on the same 5 days as they apply the intranasal mupirocin.; Other Names: CHG cloths
No Intervention: Baseline or control dyads; Maternal-infant dyads without exposure to skin decolonization treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Staph aureus burden within maternal-infant dyads after exposure to a decolonization regimen	Mucosal swabs collected in the parent study, Project HOPE biorepository are stored in RNALater to assess burden by PCR (polymerase chain reaction) at a later date.	12 months
Staph aureus epidemiology within maternal-infant dyads after exposure to a decolonization regimen	S. aureus isolates will undergo spa typing for comparison.	12 months
Participant interest in skin decolonization	Measured by a descriptive survey, Perception of Safety Survey for Pregnant Women Undergoing Skin Treatment.	12 months
Participant compliance with skin decolonization	Measured by a descriptive survey, Perception of Safety Survey for Pregnant Women Undergoing Skin Treatment.	12 months

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Bristol-Myers Squibb
• Investigators: Principal Investigator: Ibukunoluwa Kalu, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2024
• Primary Completion (Actual): October 18, 2024
• Study Completion (Actual): October 18, 2024

Study Registration Dates

• First Submitted: August 2, 2024
• First Submitted That Met QC Criteria: August 2, 2024
• First Posted (Actual): August 7, 2024

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Infant; Maternal; Neonatal; Resistant; Antimicrobial
• Additional Relevant MeSH Terms: Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Epoxy Compounds; Ethers, Cyclic; Ethers; Pyrans; Fatty Acids; Lipids; Mupirocin
• Other Study ID Numbers: Pro00115222

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes