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A randomized non-inferiority clinical trial of doxycycline vs BPG for early syphilis
EU CTIS ID: 2024-513532-23-00
What this study is testing
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).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.