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Completed

NCT Number: NCT06541145

Bacterial Decolonization Within 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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Duke University

Durham, North Carolina, 27703, United States

About this study

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:

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must be enrolled in longitudinal study Project HOPE1000.

Exclusion criteria

  • Participants not enrolled in Project HOPE1000 will be excluded.

Treatment and study plan

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.

Other names: Bactroban

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.

Other names: CHG cloths

Primary outcomes

  1. Staph aureus burden within maternal-infant dyads after exposure to a decolonization regimen

    Time frame: 12 months

    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.

  2. Staph aureus epidemiology within maternal-infant dyads after exposure to a decolonization regimen

    Time frame: 12 months

    S. aureus isolates will undergo spa typing for comparison.

  3. Participant interest in skin decolonization

    Time frame: 12 months

    Measured by a descriptive survey, Perception of Safety Survey for Pregnant Women Undergoing Skin Treatment.

  4. Participant compliance with skin decolonization

    Time frame: 12 months

    Measured by a descriptive survey, Perception of Safety Survey for Pregnant Women Undergoing Skin Treatment.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

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

Acronym: BADMC

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 7, 2024
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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