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

Trial Summary

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.

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. ^{1 2 3 4 5}

Is mupirocin safe for use on skin infections?

Mupirocin, used as a 2% ointment, is generally safe for treating skin infections, with local side effects like burning or itching occurring in less than 3% of patients. No serious side effects or systemic toxicity (harm to the body as a whole) have been reported in studies. ^{1 3 6 7 8}

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. ^{1 2 3 5 6}

Research Team

Ibukunoluwa Kalu, MD

Principal Investigator

Duke University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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 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 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]

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]

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 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]

References

1. England 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. [2013]

2. Czech Republic pubmed.ncbi.nlm.nih.gov

The use of Bactroban for infection management in burn patients. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

The clinical development of mupirocin. [2019]

4. England pubmed.ncbi.nlm.nih.gov

An open study of mupirocin in Libyan patients with skin infections. [2017]

5. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The results and characteristics of the mupirocin (Bactroban) sanative treatment of intranasal Staphylococcus carriers in a large hospital]. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Mupirocin: a topical antibiotic with a unique structure and mechanism of action. [2013]

7. United States 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. [2019]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Mupirocin. A review of its antibacterial activity, pharmacokinetic properties and therapeutic use. [2018]