Testing a new treatment for Staphylococcus Aureus decolonization
A Randomized Double-blind Placebo-controlled First-in-man Single-dose and Multiple Dose Study to Evaluate the Safety, Tolerability and Efficacy of a Recombinant Chimeric Bacteriophage Endolysin HY-133 With an Extended Phase to Evaluate Effects of the Nasal Microbiome
This study is testing a new nasal spray treatment to see if it can help healthy people get rid of Staphylococcus Aureus bacteria from their noses.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Tuebingen Academic / other |
| Locations | 2 sites (Tübingen and 1 other locations) |
| Trial ID | NCT06290557 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety, tolerability, and efficacy of a novel recombinant chimeric bacteriophage endolysin, HY-133, for decolonizing Staphylococcus Aureus in healthy subjects. Participants will receive either a single dose or multiple doses of the treatment, administered as a nasal spray, with a randomized, double-blind, placebo-controlled design to ensure unbiased results. The study aims to determine the effectiveness of HY-133 in reducing nasal colonization of methicillin-susceptible S. aureus (MSSA).
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 and older who are nasal carriers of methicillin-susceptible S. aureus.
Not a fit: Patients with methicillin-resistant S. aureus (MRSA) or significant underlying health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new method for effectively decolonizing Staphylococcus Aureus, potentially reducing infection rates.
How similar studies have performed: While this approach is innovative, similar studies using bacteriophage therapy have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Must be ≥ 18 years at the time of signing the informedconsent. * Understand and voluntarily sign an informed consent document prior to any study related * assessments/procedures. * Nasal colonization with methicillin-susceptible S. aureus (MSSA) * Female Subject of childbearing potential1 and male subjects with female partner of childbearing potential1 is willing to use highly effective contraceptive methods during treatment until end of study at D15 Exclusion Criteria * Nasal colonization with methicillin-resistant S. aureus (MRSA) * Nasal traumata including nose penetrating foreign bodies (e.g. piercings) * Presence of any significant morbidity, e.g. Diabetes, cardiovascular disease * Acute or known chronic diseases of the nose or the paranasal sinuses * Acute or known chronic diseases of other parts of the respiratory tract * Running nose due to other reasons (e.g. allergic diseases)7. Positive serological HIV, hepatitis A, B or C test. In case of positive HBsAg, volunteer must provide prove of hepatitis B vaccination, otherwise volunteer must be excluded. * Women during pregnancy and lactation. * History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product. * Participation in other clinical trials or observation period of competing trials, in the 12 weeks prior to screening. * Acute or chronic, clinically significant psychiatric, hematologic, pulmonary, cardiovascular, or hepatic or renal functional abnormality as determined by the Investigator based on medical history, physical exam, and/or laboratory screening test * Systemic antibiotic treatment in the 12 weeks prior to screening. * Intranasal eradication therapy in the 12 weeks prior to screening.
Where this trial is running
Tübingen and 1 other locations
- Department of Dermatology, University Hospital Tuebingen — Tübingen, Germany (Recruiting)
- Department of Dermatology — Tübingen, Germany (Recruiting)
Study contacts
- Study coordinator: Sebastian Volc, PD
- Email: studienzentrum.immundermatologie@med.uni-tuebingen.de
- Phone: 07071 2926745
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.