A pilot single center, open label trial to assess the impact of doxycycline postexposure prophylaxis on antimicrobial resistance (SafeDoxyPEP trial)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Institute Of Tropical Medicine, Institute Of Tropical Medicine

Participant type

Healthy volunteers

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

Trial duration

13 Mar 2024 → 19 Jun 2025

Decision date (initial)

2024-01-23

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis

Assess if doxycycline PEP can result in reduced susceptibility to doxycycline in rectal E. coli on day 180

Secondary objectives 15

1. Assess if doxycycline PEP can result in reduced susceptibility to ceftriaxone in rectal E. coli on day 180
2. Assess if doxycycline PEP can result in reduced susceptibility to ciprofloxacin in rectal E. coli on day 180
3. Assess if doxycycline PEP can result in reduced susceptibility to doxycycline in rectal K. pneumoniae on day 180
4. Assess if doxycycline PEP can result in reduced susceptibility to ceftriaxone in rectal K. pneumoniae on day 180
5. Assess if doxycycline PEP can result in reduced susceptibility to ciprofloxacin in rectal K. pneumoniae on day 180
6. Assess if doxycycline PEP can result in reduced susceptibility to doxycycline in oral streptococci on day 180
7. Assess if doxycycline PEP can result in reduced susceptibility to ceftriaxone in oral streptococci on day 180
8. Assess if doxycycline PEP can result in reduced susceptibility to ciprofloxacin in oral streptococci on day 180
9. Assess if doxycycline PEP can result in reduced susceptibility to doxycycline in oral S. aureus on day 180
10. Assess if doxycycline PEP can result in reduced susceptibility to ceftriaxone in oral S. aureus on day 180
11. Assess if doxycycline PEP can result in reduced susceptibility to ciprofloxacin in oral S. aureus on day 180
12. Assess if doxycycline PEP can result in reduced susceptibility to doxycycline in oral commensal Neisseria spp. on day 180
13. Assess if doxycycline PEP can result in reduced susceptibility to ceftriaxonein oral commensal Neisseria spp. on day 180
14. Assess if doxycycline PEP can result in reduced susceptibility to ciprofloxacin in oral commensal Neisseria spp. on day 180
15. Assess the effect of doxycycline PEP in susceptibility to all the above antibiotics and bacteria combinations on day 180, adjusting for doxycycline consumption, antibiotic use and other confounders.

Conditions and MedDRA coding

Bacterial sexually transmittable diseases (chlamydia, gonorrhea, syphilis)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Able and willing to provide written informed consent
2. Age 18 years old or older
3. Eligible to take HIV PrEP
4. Male sex at birth

Exclusion criteria 3

1. Use of any antibiotics in the previous 3 months
2. Known contra-indications or allergy to doxycycline, gluten or lactose
3. Currently using or planning to use anticoagulants based on vitamin K antagonism (warfarin, acenocoumarol, fenprocoumon)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Shift in the distribution of minimum inhibitory concentration (MIC) of doxycycline in rectal E. coli on day 180.

Secondary endpoints 14

1. Shift in the distribution of MIC of ceftriaxone in rectal E. coli on day 180.
2. Shift in the distribution ofMIC of ciprofloxacin in rectal E. coli on day 180.
3. Shift in the distribution of MIC of doxycycline in rectal K. pneumoniae on day 180.
4. Shift in the distribution of MIC of ceftriaxone in rectal K. pneumoniae on day 180
5. Shift in the distribution of MIC of ciprofloxacin in rectal K. pneumoniae on day 180
6. Shift in the distribution of MIC of doxycycline in oral streptococci on day 180
7. Shift in the distribution of MIC of ceftriaxone in oral streptococci on day 180
8. Shift in the distribution of MIC of ciprofloxacin in oral streptococci on day 180
9. Shift in the distribution of MIC of doxycycline in oral S. aureus on day 180
10. Shift in the distribution of MIC of ceftriaxone in oral S. aureus on day 180
11. Shift in the distribution of MIC of ciprofloxacin in oral S. aureus on day 180
12. Shift in the distribution of MIC of doxycycline in oral commensal Neisseria spp. on day 180
13. Shift in the distribution of MIC of ceftriaxone in oral commensal Neisseria spp. on day 180
14. Shift in the distribution of MIC of ciprofloxacin in oral commensal Neisseria spp. on day 180

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Institute Of Tropical Medicine

Sponsor organisation

Institute Of Tropical Medicine

Address

Nationalestraat 155

City

Antwerp

Postcode

2000

Country

Belgium

Scientific contact point

Organisation

Institute Of Tropical Medicine

Contact name

Chris Kenyon

Public contact point

Organisation

Institute Of Tropical Medicine

Contact name

Chris Kenyon

Institute Of Tropical Medicine

Sponsor organisation

Institute Of Tropical Medicine

Address

Nationalestraat 155

City

Antwerp

Postcode

2000

Country

Belgium

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

2 submissions — initial application plus substantial / non-substantial modifications