What is the mechanism of action of this treatment?

Common treatments for Staph infections include antibiotics such as beta-lactams (e.g., methicillin), which inhibit cell wall synthesis, and vancomycin, which disrupts cell wall formation in resistant strains. Additionally, nasal decolonization strategies, like mupirocin ointment, target nasal carriage of Staph by inhibiting bacterial protein synthesis. The concept of nasal microbiota transfer involves introducing beneficial bacteria to outcompete pathogenic Staph strains, potentially reducing infection rates. Understanding these mechanisms is crucial for patients as it informs the choice of effective treatments and highlights the potential of innovative approaches like microbiota transfer to prevent recurrent infections.

What side effects are associated with this type of intervention?

Common treatments for Staph infections, such as antibiotics and microbiota-based therapies, have varying side effects. Antibiotics like linezolid can cause thrombocytopenia, anemia, and serotonin toxicity, while vancomycin may lead to nephrotoxicity and ototoxicity. Probiotics and microbiota transplants, including nasal microbiota transfer, generally have a good safety profile but may pose a risk of infection in immunocompromised individuals.

What prior FDA approvals exist?

Prior FDA approvals for the treatment of Staph infections include antibiotics such as ceftaroline, co-trimoxazole (trimethoprim-sulfamethoxazole), vancomycin, and teicoplanin. These drugs are effective against Methicillin-resistant Staphylococcus aureus (MRSA) and other Staph infections. The Nasal Microbiota Transfer trial aims to explore a different approach by colonizing the nasal passages with beneficial bacteria, potentially offering an alternative to traditional antibiotic treatments.

What other types of research exist?

Promising novel alternatives to Nasal Microbiota Transfer for Staph infection patients include bacteriophage therapy, which uses viruses that specifically target and kill bacteria, and antimicrobial peptides (AMPs), which are part of the innate immune system and can destroy bacteria. Additionally, photodynamic therapy and ultraviolet (UV) light application are emerging as potential treatments. These methods are being explored due to their effectiveness against antibiotic-resistant bacteria.

← Back to Search

Microbiota Transplant

Nasal Microbiota Transplant for Preventing Newborn Infections (ParentsTREAT Trial)

Phase 1

Waitlist Available

Led By Aaron Milstone

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 4, 7, 10, 14 days post-intervention

Summary

This trial is testing if transferring healthy bacteria from a parent's nose to their newborn's nose can help protect the baby from harmful bacteria. The study focuses on newborns at Johns Hopkins Hospital. By creating a healthy bacterial environment in the baby's nose, the researchers hope to reduce the risk of infections.

Who is the study for?

This trial is for newborns who are expected to stay in the neonatal intensive care unit for over a week and are at least 25 weeks gestation. They must not be colonized with S. aureus, nor should their parent/provider, who also needs to consent and be free of respiratory illness or recent COVID-19.

What is being tested?

The study tests if transferring healthy nasal microbiota from a parent to their infant can establish a diverse nasal microbiome in the baby. Infants will either receive this nasal microbiota transplant (NMT) or a placebo.

What are the potential side effects?

As this is a feasibility and safety study, specific side effects aren't listed but may include potential risks associated with altering an infant's nasal microbial environment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 4, 7, 10, 14 days post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 4, 7, 10, 14 days post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 4, 7, 10, 14 days post-intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Neonatal nasal microbiome diversity after intervention

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: indirect NMTExperimental Treatment1 Intervention

swab parent nares, inoculate swab into saline, instill liquid into neonate nares

Group II: direct NMTExperimental Treatment1 Intervention

swab parent nares then insert swab directly into neonate nares

Group III: placeboPlacebo Group1 Intervention

instill sterile saline into neonate nares

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Staph infections include antibiotics such as beta-lactams (e.g., methicillin), which inhibit cell wall synthesis, and vancomycin, which disrupts cell wall formation in resistant strains. Additionally, nasal decolonization strategies, like mupirocin ointment, target nasal carriage of Staph by inhibiting bacterial protein synthesis. The concept of nasal microbiota transfer involves introducing beneficial bacteria to outcompete pathogenic Staph strains, potentially reducing infection rates. Understanding these mechanisms is crucial for patients as it informs the choice of effective treatments and highlights the potential of innovative approaches like microbiota transfer to prevent recurrent infections.

Modelling of the transmission dynamics of carbapenem-resistant Klebsiella pneumoniae in hospitals and design of control strategies.Effect of the duration of antimicrobial exposure on the development of antimicrobial resistance (AMR) for macrolide antibiotics: protocol for a systematic review with a network meta-analysis.Antimicrobials for right-sided endocarditis in intravenous drug users: a systematic review.