Bacterial Decolonization Within Dyads

NCT06541145 | Recruiting DMC

• 1 other identifier: Pro00115222
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bacterial Colonization

Keywords

Maternal; Infant; Neonatal; Resistant; Antimicrobial

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Maternal Skin Decolonization

EXPERIMENTAL

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; Drug: Chlorhexidine baths

Baseline or control dyads

NO INTERVENTION

Maternal-infant dyads without exposure to skin decolonization treatment

Interventions

Mupirocin DRUG

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.

Also known as: Bactroban

Maternal Skin Decolonization

Chlorhexidine baths DRUG

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.

Also known as: CHG cloths

Maternal Skin Decolonization

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be enrolled in longitudinal study Project HOPE1000.

You may not qualify if:

• Participants not enrolled in Project HOPE1000 will be excluded.

Sponsors & Collaborators

• Duke University: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27703, United States

RECRUITING

MeSH Terms

Interventions

Mupirocin

Intervention Hierarchy (Ancestors)

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

Study Officials

• Ibukunoluwa Kalu, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ibukunoluwa Kalu, MD

CONTACT

(919) 684-6335; ica5@duke.edu

Kirsten Jenkins

CONTACT

(919) 668-4736; kirsten.jenkins@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 7, 2024
• Study Start: August 21, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)