Could a simple pill replace the shot for syphilis?
NCT ID NCT04838717
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a 14-day course of doxycycline pills works as well as the standard penicillin shot for curing early syphilis. About 200 adults with early-stage syphilis took part. The goal is to offer a reliable oral option, especially when penicillin is in short supply.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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200 people
The number who actually took part.
- Started
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Dec 2021
- Finished
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Jul 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CHRU Jean Minjoz
Besançon, 25000, France
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CHU Toulouse - Hôpital de la Grave - GeGIDD
Toulouse, 34000, France
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Hôpital Henri Mondor
Créteil, 94000, France
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Hôpital Hotel Dieu
Paris, 75001, France
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Hôpital Saint Louis - GeGIDD
Paris, 75009, France
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Hôpital Saint Louis - SMIT
Paris, 75009, France
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Hôpital de la Croix Rousse
Lyon, 69000, France
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Other studies related to the condition(s) this trial covers.
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- ER syphilis screening for pregnant women could save lives
- Could a pill replace the shot for syphilis?