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

Phase 3

Active, not recruiting

• Conditions: early syphilis

• Registration Number: 2024-513532-23-00
• Lead Sponsor: Assistance Publique Hopitaux De Paris

Brief Summary

The main objective of our study is to show that 100 mg doxycycline bid for 14 days is non-inferior to a single intramuscular injection of 2.4 x 106 IU of BPG for the treatment of early syphilis, evaluated as a four-fold decrease in titer in the non-treponemal assay (VDRL or RPR) at month 6 (widely used as the definition of cure in real-life settings).

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-06-28
• Last Update Posted: 2025-01-15

Recruitment & Eligibility

• Status: Ongoing, recruitment ended
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

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 Criteria

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

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 (within the last three months) to either of the two study drugs

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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		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 Outcome Measures

Name	Time	Method
Occurrence of SAEs in the two groups		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		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		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		Titer obtained in the non-treponemal assay (VDRL or RPR) at month 3 evolution

Trial Locations

Locations (15)

Assistance Publique Hopitaux De Paris; 🇫🇷 Paris, France

Departement Des Bouches Du Rhone; 🇫🇷 Marseille, France

Centre Hospitalier De Pau; 🇫🇷 Pau Cedex, France

Centre Hospitalier Universitaire De Nantes; 🇫🇷 Nantes, France

Centre Hospitalier Universitaire De Bordeaux; 🇫🇷 Bordeaux, France

Hospices Civils De Lyon; 🇫🇷 Lyon Cedex 04, France

Centre Hospitalier Universitaire De La Reunion; 🇫🇷 Saint-Denis, France

Centre Hospitalier William Morey; 🇫🇷 Chalon Sur Saone Cedex, France

Centre Hospitalier Universitaire De Rennes; 🇫🇷 Rennes, France

CHU De Martinique; 🇫🇷 Fort De France Cedex, France

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Assistance Publique Hopitaux De Paris

🇫🇷Paris, France

Aurélien DINH

Site contact

0147107760

aurelien.dinh@aphp.fr

Nicolas DUPIN

Site contact

0158411849

nicolas.dupin@aphp.fr

Gentiane MONSEL

Site contact

0184827371

gentiane.monsel@aphp.fr

Romain SALLE

Site contact

0149094482

romain.salle@aphp.fr

Sébastien FOUERE

Site contact

0142499924

sebastien.fouere@aphp.fr

Myriam DIEMER

Site contact

0149958388

myriam.diemer@aphp.fr

Emma RUBENSTEIN

Site contact

0142494512

emma.rubenstein@aphp.fr