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Could a simple pill replace the shot for syphilis?

NCT ID NCT04838717

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

200 people

The number who actually took part.

Started

Dec 2021

Finished

Jul 2025

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • CHRU Jean Minjoz

    Besançon, 25000, France

  • CHU Toulouse - Hôpital de la Grave - GeGIDD

    Toulouse, 34000, France

  • Hôpital Henri Mondor

    Créteil, 94000, France

  • Hôpital Hotel Dieu

    Paris, 75001, France

  • Hôpital Saint Louis - GeGIDD

    Paris, 75009, France

  • Hôpital Saint Louis - SMIT

    Paris, 75009, France

  • Hôpital de la Croix Rousse

    Lyon, 69000, France

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