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A randomized non-inferiority clinical trial of doxycycline vs BPG for early syphilis

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513532-23-00
Acronym
APHP180588
Enrollment
200
Registered
2024-06-28
Start date
2021-12-06
Completion date
2025-07-23
Last updated
2025-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

early syphilis

Brief summary

A response will be defined as a four-fold decrease (2 dilutions) in titer in the non-treponemal assay (VDRL or RPR) at month 6 relative to the results of the assay performed before treatment. The two assays (before treatment and at month 6) should be performed in the same laboratory

Detailed description

Occurrence of SAEs in the two groups, Adherence to doxycycline, evaluated on the basis of a tablet count between weeks 1 and 2, during planned visits, Occurrence of other STDs in the two groups at month 6, Titer obtained in the non-treponemal assay (VDRL or RPR) at month 3 evolution

Interventions

DRUGcomprimé sécable
DRUGEXTENCILLINE 2
DRUG4 MUI
DRUGpoudre et solvant pour suspension injectable IM

Sponsors

Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
A response will be defined as a four-fold decrease (2 dilutions) in titer in the non-treponemal assay (VDRL or RPR) at month 6 relative to the results of the assay performed before treatment. The two assays (before treatment and at month 6) should be performed in the same laboratory

Secondary

MeasureTime frame
Occurrence of SAEs in the two groups, Adherence to doxycycline, evaluated on the basis of a tablet count between weeks 1 and 2, during planned visits, Occurrence of other STDs in the two groups at month 6, Titer obtained in the non-treponemal assay (VDRL or RPR) at month 3 evolution

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026