Skin Treatment for Bacterial Colonization
(BADMC Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
Is mupirocin safe for use on skin infections?
How is the drug mupirocin unique for treating bacterial skin colonization?
Mupirocin is unique because it is a topical antibiotic with a distinct structure and mechanism, specifically inhibiting bacterial protein synthesis, and is effective against common skin bacteria like Staphylococcus and Streptococcus. Unlike other antibiotics, it is used only on the skin and does not get absorbed into the body, reducing the risk of systemic side effects.12367
What data supports the effectiveness of the drug mupirocin in treating skin infections?
Research shows that mupirocin is effective in treating skin infections caused by bacteria like staphylococci and streptococci, with high cure rates and minimal side effects. In various studies, mupirocin ointment cured a significant percentage of patients with skin infections, demonstrating its safety and effectiveness.12678
Who Is on the Research Team?
Ibukunoluwa Kalu, MD
Principal Investigator
Duke University
Are You a Good Fit for This Trial?
This trial is for mothers and their infants enrolled in the Project HOPE1000 study. It's designed to see if treating mothers' skin with antiseptic before giving birth can reduce bacteria spread, specifically Staph aureus, between them and their babies.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo a 5-day decolonization treatment with intranasal mupirocin and chlorhexidine baths
Follow-up
Participants are monitored for compliance and effectiveness of the decolonization treatment
What Are the Treatments Tested in This Trial?
Interventions
- Chlorhexidine baths
- Mupirocin
Mupirocin is already approved in United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Duke University
Lead Sponsor
Bristol-Myers Squibb
Industry Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania