Skin Treatment for Bacterial Colonization

(BADMC Trial)

Overseen By Kirsten Jenkins

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Not in Project HOPE1000

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 week

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand the presence of Staph aureus bacteria on the skin and its transmission between mothers and their newborns. Researchers are testing a skin treatment that includes mupirocin (an antibiotic ointment) and special chlorhexidine baths to determine if it reduces the bacteria before birth. They are also assessing mothers' interest in these treatments and their adherence to the treatment plan. Pregnant women in their third trimester participating in another study, Project HOPE1000, might be suitable candidates for this trial. As an unphased trial, this study offers participants the chance to contribute to important research on preventing bacterial spread between mothers and newborns.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that mupirocin is usually safe for skin use, though some people might experience mild skin reactions. Common side effects include redness, itching, or a burning sensation at the application site. In rare cases, more serious allergic reactions, such as swelling or difficulty breathing, have been reported.

Chlorhexidine baths are also generally safe for the skin. Some individuals might experience minor irritation, like itchy or red skin. The FDA has noted rare but serious allergic reactions with chlorhexidine, so monitoring for any unusual symptoms is important.

Both treatments help reduce skin bacteria and are generally considered safe. However, it's crucial to watch for any side effects and consult a healthcare professional if they occur. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this trial because it explores a new approach to reducing bacterial colonization in pregnant women, using a combination of intranasal mupirocin and chlorhexidine baths. Unlike other treatments that might focus solely on infection after it has occurred, this method proactively targets potential bacterial colonization before delivery. This five-day regimen is designed to be safe and well-tolerated, potentially offering a preventative measure that could reduce the risk of infections for both mothers and their newborns. By targeting bacterial presence in the third trimester, this approach could lead to healthier outcomes during delivery.

What evidence suggests that this trial's treatments could be effective for reducing bacterial colonization?

In this trial, participants in the experimental arm will receive a combination of intranasal mupirocin and chlorhexidine baths for a 5-day decolonization regimen. Research has shown that mupirocin effectively reduces Staphylococcus aureus bacteria; one study found that 93% of people treated with mupirocin had the bacteria completely removed. Chlorhexidine baths also effectively reduce skin bacteria, helping to prevent infections. Together, these treatments significantly lower the risk of bacterial infections. ^{6 7 8 9 10}

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

Participants must be enrolled in longitudinal study Project HOPE1000.

Exclusion Criteria

Participants not enrolled in Project HOPE1000 will be excluded.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 5-day decolonization treatment with intranasal mupirocin and chlorhexidine baths

1 week

2 visits (in-person)

Follow-up

Participants are monitored for compliance and effectiveness of the decolonization treatment

12 months

Weekly check-ins (virtual), routine visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Chlorhexidine baths
• Mupirocin

Trial Overview

The interventions being tested are Mupirocin ointment and Chlorhexidine baths. The study will measure bacterial levels on the skin of mothers and infants to determine if these treatments prevent the spread of bacteria.

How Is the Trial Designed?

Group I: Maternal Skin Decolonization Experimental Treatment 2 Interventions

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

Group II: Baseline or control dyads Active Control 1 Intervention

Maternal-infant dyads without exposure to skin decolonization treatment

Mupirocin is already approved in United States for the following indications:

Approved in United States as Bactroban for:

• Impetigo
• Nasal Carriage of Staphylococcus aureus
• Paronychia
• Secondary Cutaneous Bacterial Infections
• Skin and Structure Infection

Approved in United States as Centany for:

• Impetigo
• Secondarily infected traumatic skin lesions

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Bristol-Myers Squibb

Industry Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

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

Published Research Related to This Trial

Mupirocin is a unique antibiotic effective against specific gram-positive bacteria, particularly Staphylococcus aureus and Streptococcus pyogenes, making it a valuable treatment option for skin infections.

Clinical trials have demonstrated that mupirocin, when used topically as Bactroban ointment, is both safe and effective for treating impetigo, with no systemic absorption observed even after prolonged use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The clinical development of mupirocin. Pappa, KA.[2019]

In a study involving 1,391 patients with superficial skin infections, mupirocin 2% ointment demonstrated high efficacy, curing 73.7% of patients and significantly improving symptoms in 22.5% after an average treatment of nine days.

Mupirocin was found to be safe, with only 2.9% of patients experiencing mild local side effects, and no evidence of systemic toxicity or abnormal lab results, making it a reliable option for treating skin infections caused by staphylococci and streptococci.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of 2% mupirocin ointment in the treatment of primary and secondary skin infections--an open multicentre trial. Bork, K., Brauers, J., Kresken, M.[2013]

In a study of 60 patients with impetigo, 2% mupirocin ointment (Bactroban) demonstrated a statistically and clinically significant advantage in overall efficacy and safety compared to oral erythromycin ethylsuccinate.

Both treatments achieved a 100% bacteriologic success rate, but mupirocin had no reported adverse experiences, while 13% of patients on erythromycin reported side effects, highlighting mupirocin's better safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A bacteriologically controlled, randomized study comparing the efficacy of 2% mupirocin ointment (Bactroban) with oral erythromycin in the treatment of patients with impetigo. McLinn, S.[2019]

Mupirocin (Bactroban) nasal ointment was found to be highly effective, achieving a 100% efficacy rate in eradicating nasal staphylococcal strains among 37 medical workers, with a 93% success rate specifically against methicillin-resistant Staphylococcus aureus (MRSA).

The treatment was well-tolerated with no recorded complications, and it significantly reduced the presence of MRSA and methicillin-resistant coagulase-negative staphylococci (MRSC) in nasal passages, indicating its potential for controlling staphylococcal infections in hospital settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The results and characteristics of the mupirocin (Bactroban) sanative treatment of intranasal Staphylococcus carriers in a large hospital]. Lykova, EA., Eremina, LV., Sterkhova, GV., et al.[2016]

Mupirocin is a topical antibiotic effective against impetigo and other skin infections, showing significant clinical and bacteriological cures compared to standard treatments like ampicillin and as effective as cloxacillin and erythromycin in controlled trials.

The drug works by inhibiting bacterial protein and RNA synthesis through its unique mechanism of action, but it is only used topically due to rapid systemic metabolism, and while it has local adverse effects, these are generally related to its formulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mupirocin: a topical antibiotic with a unique structure and mechanism of action. Parenti, MA., Hatfield, SM., Leyden, JJ.[2013]

Bactroban was successfully used as a local antimicrobial treatment in 25 patients with deep skin infections at a burn center, particularly effective against Staphylococcus infections.

The treatment showed positive therapeutic results, especially in cases where other common antimicrobial preparations had failed, and no resistant Staphylococcus strains were observed during the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of Bactroban for infection management in burn patients. Vrtisková, J., Königová, R.[2013]

Mupirocin is a topical antibacterial agent that effectively treats superficial skin infections, with over 80% of patients showing clinical improvement and more than 90% eradication of the bacteria involved.

It has a low incidence of side effects, primarily limited to local reactions in less than 3% of patients, making it a safe option for treating conditions like impetigo, although further studies are needed to clarify its role compared to other antibacterial agents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mupirocin. A review of its antibacterial activity, pharmacokinetic properties and therapeutic use. Ward, A., Campoli-Richards, DM.[2018]

In a study involving 48 patients with skin infections, mupirocin, a new topical antibiotic, was applied three times daily for 7 days, resulting in a 93.5% cure rate by day 7 and a 100% cure rate one week later.

The treatment was found to be safe, with no reported adverse events or skin reactions, demonstrating mupirocin's efficacy and safety for treating skin infections caused by staphylococci and streptococci.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An open study of mupirocin in Libyan patients with skin infections. El Ferghani, N.[2017]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12286417/

Chlorhexidine gluconate skin levels and organism ...

Bathing with the antiseptic chlorhexidine gluconate (CHG) is increasingly being used to reduce bioburden on patient skin to help lower the risk of colonization ...

2.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2831186

Universal vs Targeted Chlorhexidine Bathing and Nasal ...

The findings of this study suggest that, in most general inpatient units, chlorhexidine bathing and nasal decolonization may be a cost-effective way to reduce ...

3.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa2215254

Decolonization in Nursing Homes to Prevent Infection and ...

In ICUs, universal decolonization with chlorhexidine and nasal mupirocin reduced the risk of an MRSA-positive clinical culture by 37% and of all-cause ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S0196655316002005

Effect of chlorhexidine bathing in preventing infections and ...

This review examines the evidence that chlorhexidine bathing can prevent colonization and infection with health care-associated pathogens and reduce ...

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aricjournal.biomedcentral.com

aricjournal.biomedcentral.com/articles/10.1186/s13756-025-01606-6

Can chlorhexidine gluconate baths reduce fungal colonisation ...

Our study demonstrated that CHG bathing did not effectively reduce the acquisition or decolonisation of Candida spp. among ICU patients.

6.

mayoclinic.org

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Chlorhexidine (topical application route) - Side effects & ...

Because of chlorhexidine's potential for causing excessive skin irritation and the risk of increased absorption through the skin, use in ...

7.

fda.gov

fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-warns-about-rare-serious-allergic-reactions-skin-antiseptic

FDA warns about reactions with antiseptic chlorhexidine ...

FDA Drug Safety Communication: FDA warns about rare but serious allergic reactions with the skin antiseptic chlorhexidine gluconate.

8.

nhs.uk

nhs.uk/medicines/chlorhexidine/side-effects-of-chlorhexidine/

Side effects of chlorhexidine

There are no common side effects with chlorhexidine skin treatments. However, in rare cases, some people may get itchy, irritated or red skin.

9.

poison.org

poison.org/articles/chlorhexidine-adverse-effects-172

Chlorhexidine Adverse Effects

After ingesting approximately 100 milliliters of a chlorhexidine 5% solution, a woman developed a life-threatening condition called methemoglobinemia.

10.

mayoclinic.org

mayoclinic.org/drugs-supplements/chlorhexidine-oral-route/description/drg-20068551

Chlorhexidine (oral route) - Side effects & dosage

Chlorhexidine may cause staining and an increase in tartar (calculus) on your teeth. Brushing with a tartar-control toothpaste and flossing your ...