Influence of Doxycycline Use as Prophylaxis for Sexually Transmitted Infections on Bacterial Resistance and Gut Microbiota: MiDoxyR-PEP Study

2025-525150-19-01 · tracked via the Priya Life Science EU tracker

Sponsor

Instituto De Investigacion Marques De Valdecilla

Sponsor type

Laboratory/Research/Testing facility

Therapeutic area

Bacterial Infections and Mycoses

Decision date

06/08/2026

Enrollment target

392

Sites

Spain

Condition studied

Colonization by methicillin-resistant S. aureus and gut microbiota in users of pre-exposure prophylaxis (PrEP) and people living with HIV (PLHIV) with STIs.

Investigational medicinal product(s)

TENOFOVIR DISOPROXIL AND EMTRICITABINEDovato 50 mg/300 mg film-coated tabletsJuluca 50 mg/25 mg film-coated tabletsDOXYCYCLINEOdefsey 200 mg/25 mg/25 mg film-coated tabletsTriumeq 50 mg/600 mg/300 mg film-coated tabletsBiktarvy 30 mg/120 mg/15 mg film-coated tablets

Eligibility

Age group

65+ years, 18-64 years

Sex

Male

Primary endpoint

to assess the prevalence of nasal colonization by doxycycline-resistant S. aureus strains

Endpoint detail

To assess differences in the composition of the baseline gut microbiota and at month 12, To assess the development of resistance in the gut microbiota, To assess the prevalence of infections caused by T. pallidum, C. trachomatis, and N. gonorrhoeae, and doxycycline-resistant C. trachomatis.

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-525150-19-01 on CTIS ↗ ← All trials in the EU