Status:
COMPLETED
Clinical Trial of Doxycycline VS BPG for Early Syphilis (SY-DOXY)
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
URC-CIC Paris Descartes Necker Cochin
Conditions:
Syphilis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
According to European and US Centers for Disease Control and Prevention (CDC) guidelines, the recommended treatment for uncomplicated early syphilis in adults (i.e. primary, secondary and early latent...
Eligibility Criteria
Inclusion
- Patients aged ≥ 18 years
- Patients who, after the nature of the study has been explained to them, and before any protocol-specific procedures are performed, give informed consent in writing, in accordance with local regulatory requirements
- Patients with or without HIV infection and with syphilis infection in the early stages according to CDC criteria (primary syphilis, secondary syphilis and early latent syphilis of less than one year's duration)
- Patients with a positive non-treponemal assay result
- Patients available for participation and follow-up during the 6 months of the study
- Patients covered by the French health insurance system
Exclusion
- Individuals with a history of known hypersensitivity to doxycycline or any other antibiotic of the tetracycline family, BPG (hypersensitivity to the active substance benzathine benzylpenicillin, to other penicillins, to soy phospholipids, peanuts or any of the excipients in the product ; history of severe immediate hypersensitivity reactions (eg anaphylaxis) to other beta-lactams (examples: cephalosporins, carbapenemes or monobactams), lidocaïne (hypersensitivity to lidocaine hydrochloride, amide-linked local anesthetics, or any of the excipients listed in SPC) and / or any of the excipients of the specialties used in the study
- Patients with a negative non-treponemal assay result
- Patients receiving an anticoagulant therapy
- Individuals with contraindications for either of the study drugs
- Individuals treated with retinoids by general route
- Individuals with early and late neurosyphilis
- Individuals requiring doxycycline treatment
- Individuals with late syphilis, whether or not latent (e.g. cutaneous)
- Individuals with thrombocytopenia or coagulation disorders contraindicating intramuscular injections
- Women who are pregnant or breast-feeding, or of childbearing age not using or planning to use acceptable birth control measures;
- Individuals under a measure of legal protection or unable to consent
- Individuals participating in any clinical trial with another investigational product in the 28 days preceding the first study visit or intending to participate in another clinical study at any time during the course of this study.
- Recent exposure
Key Trial Info
Start Date :
December 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 23 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04838717
Start Date
December 6 2021
End Date
July 23 2025
Last Update
November 20 2025
Active Locations (7)
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1
CHRU Jean Minjoz
Besançon, France, 25000
2
Hôpital Henri Mondor
Créteil, France, 94000
3
Hôpital de la Croix Rousse
Lyon, France, 69000
4
Hôpital Hotel Dieu
Paris, France, 75001