Bacterial ColonizationBADMCNCT06541145
Bacterial Decolonization Within Dyads
A study testing Mupirocin and Chlorhexidine baths in people with Bacterial Colonization, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Bacterial Colonization
- What is being tested?
- Mupirocin and Chlorhexidine baths
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2024to 18 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be enrolled in longitudinal study Project HOPE1000.
Who cannot join
- Participants not enrolled in Project HOPE1000 will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- 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.
- Conditions
- Bacterial Colonization
- Being tested
- Mupirocin, Chlorhexidine baths
- Keywords
- Maternal, Infant, Neonatal, Resistant, Antimicrobial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MupirocinDrug
Also called Bactroban
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.
Chlorhexidine bathsDrug
Also called CHG cloths
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Mupirocin; Drug: Chlorhexidine baths |
| Baseline or control dyads | No intervention | Maternal-infant dyads without exposure to skin decolonization treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Staph aureus epidemiology within maternal-infant dyads after exposure to a decolonization regimen
- aureus isolates will undergo spa typing for comparison.
Measured: 12 months
Participant interest in skin decolonization
Measured by a descriptive survey, Perception of Safety Survey for Pregnant Women Undergoing Skin Treatment.
Measured: 12 months
Participant compliance with skin decolonization
Measured by a descriptive survey, Perception of Safety Survey for Pregnant Women Undergoing Skin Treatment.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start21 Aug 2024
- Primary completion18 Oct 2024
- Study completion18 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial ColonizationStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Ibukunoluwa Kalu, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06541145
- Sponsor's protocol ID
- Pro00115222
- Acronym
- BADMC
- Status last verified
- Dec 2025
- First submitted
- 2 Aug 2024
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Bacterial Decolonization on Bacterial Burden Within Maternal-infant Dyads
- ClinicalTrials.gov ID
- NCT06541145
- Acronym / sponsor ID
- BADMC / Pro00115222
- Conditions
- Bacterial Colonization
- Keywords
- Maternal, Infant, Neonatal, Resistant, Antimicrobial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 21 Aug 2024 (actual)
- Primary completion
- 18 Oct 2024 (actual)
- Study completion
- 18 Oct 2024 (actual)
- First posted
- 7 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maternal Skin Decolonization | Experimental | Drug: Mupirocin, Drug: Chlorhexidine bathsThese 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 |
| Baseline or control dyads | No intervention | –Maternal-infant dyads without exposure to skin decolonization treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants must be enrolled in longitudinal study Project HOPE1000.
Key exclusion criteria (1 listed)
- Participants not enrolled in Project HOPE1000 will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MupirocinAlso: BactrobanParticipants 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. | Drug | Maternal Skin Decolonization |
| Chlorhexidine bathsAlso: CHG clothsParticipants 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. | Drug | Maternal Skin Decolonization |
Primary outcome
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.
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.
Participant interest in skin decolonization
Time frame: 12 months
Measured by a descriptive survey, Perception of Safety Survey for Pregnant Women Undergoing Skin Treatment.
Participant compliance with skin decolonization
Time frame: 12 months
Measured by a descriptive survey, Perception of Safety Survey for Pregnant Women Undergoing Skin Treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Bacterial Colonization
Enrolling by invitation
Effects of Three Oral Hygiene Protocols on Oral Bacteria in Intensive Care Patients
Oral Bacterial Colonization, Oral Hygiene
Not yet recruitingObservational study
Prevalence of Asymptomatic Bacteriuria Among Pregnant Women With Pre-eclampsia in Women Health Hospital Assiut University
Pre-Eclampsia, Asymptomatic Bacteriuria
Recruiting
The Genital Microbiome of Male Partners of Women With Recurrent BV Undergoing Vaginal Microbiome Transplantation
Bacterial Vaginosis, Microbial Colonization
Not yet recruitingObservational study
Secondary Bacterial Infections and Nasal Colonization in Scabies and Atopic Dermatitis
Atopic Dermatitis (AD), Scabies
Active, not recruitingPhase 1
Comparing Single Versus Repeat NMT on the Diversity of the Neonatal Nasal Microbiome
Staphylococcus Aureus, Microbial Colonization
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ibukunoluwa Kalu, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mupirocin and Chlorhexidine baths in people with Bacterial Colonization, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Staph aureus burden within maternal-infant dyads after exposure to a decolonization regimen (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.