Study Comparing Doxycycline and Benzathine Benzylpenicillin for Treating Early Syphilis in Adults

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What is this study about?

This clinical trial is focused on studying the treatment of early syphilis, a sexually transmitted infection that can cause serious health problems if not treated. The study compares two treatments: doxycycline and benzathine benzylpenicillin (BPG). Doxycycline is an antibiotic taken orally in the form of a tablet, while benzathine benzylpenicillin is given as a single injection into the muscle.

The purpose of the study is to determine if taking doxycycline twice a day for 14 days is as effective as a single injection of benzathine benzylpenicillin for treating early syphilis. Participants in the study will be randomly assigned to receive either the doxycycline tablets or the benzathine benzylpenicillin injection. The effectiveness of the treatments will be evaluated by checking for a decrease in the level of the infection in the blood after six months.

Throughout the study, participants will have regular follow-up visits to monitor their health and the progress of the treatment. The study aims to provide valuable information on the effectiveness of these treatments for early syphilis, which could help improve future treatment options for this condition.

1 joining the study

Upon joining the study, the patient must provide written consent after understanding the study’s nature.

Eligibility includes being 18 years or older, having early syphilis, and being available for follow-up for 6 months.

2 initial assessment

An initial assessment is conducted to confirm early syphilis through a positive non-treponemal assay result.

The patient may have or not have an HIV infection.

3 treatment allocation

The patient is randomly assigned to one of two treatment groups: doxycycline or BPG (benzathine benzylpenicillin).

4 doxycycline treatment

If assigned to the doxycycline group, the patient takes 100 mg of doxycycline orally twice a day for 14 days.

Adherence to the medication is monitored through a tablet count between weeks 1 and 2.

5 BPG treatment

If assigned to the BPG group, the patient receives a single intramuscular injection of 2.4 million IU of BPG.

6 follow-up visits

The patient attends follow-up visits to monitor treatment response and any side effects.

A non-treponemal assay is performed at month 3 to evaluate the evolution of the titer.

7 final assessment

At month 6, a final assessment is conducted to determine the treatment’s effectiveness.

A successful response is defined as a four-fold decrease in titer in the non-treponemal assay compared to the initial result.

8 evaluation of other conditions

The occurrence of other sexually transmitted diseases (STDs) is evaluated at month 6.

Any serious adverse events (SAEs) are recorded and compared between the two groups.

Who Can Join the Study?

Patients must be 18 years or older.
Patients must understand the study and agree in writing to participate before any study procedures begin.
Patients can have HIV infection or not, but must have early syphilis. This includes primary syphilis, secondary syphilis, or early latent syphilis that has lasted less than one year.
Patients must have a positive result on a specific blood test for syphilis, known as a non-treponemal assay.
Patients must be available to participate and attend follow-up visits for the 6 months duration of the study.
Patients must be covered by the French health insurance system.

Who Cannot Join the Study?

Individuals who are not diagnosed with early syphilis cannot participate. Early syphilis is a stage of a sexually transmitted infection caused by bacteria.
Participants must be within the specified age range, which typically includes adults. If you are outside this age range, you cannot participate.
Both males and females are eligible, so gender is not a reason for exclusion.
Individuals who are considered part of a vulnerable population, such as those unable to give informed consent, are not eligible to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Centre Hospitalier De Tourcoing	Tourcoing	France
Centre Hospitalier Universitaire De La Reunion	St Denis	France
Centre Hospitalier William Morey	Chalon Sur Saone	France
Centre Hospitalier De Valenciennes	Valenciennes	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Universitaire De Rennes	Rennes	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Centre Hospitalier De Pau	Pau	France
CHU De Martinique	Fort De France	France
Czyhng Hsxngptcazw Iyrcqfbjswvef Du Fywydepjdagbdtwxazwpu	Frejus	France
Dukpelnpolt Dux Bfqeioa Dq Rreem	Marseille	France
Bfwatokm Utphsisurp Hoztxggu Ciedji	Besançon	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	06.12.2021

Trial locations

Investigated drugs:

Doxycycline is an antibiotic used in this trial to treat early syphilis. It is taken orally and works by stopping the growth of bacteria. In this study, it is being compared to another treatment to see if it is just as effective.

BPG, or Benzathine Penicillin G, is an antibiotic given as an injection. It is used to treat early syphilis by killing the bacteria that cause the infection. In this trial, it serves as the standard treatment against which doxycycline is being compared.

Investigated diseases:

Syphilis

Early Syphilis – Early syphilis is a sexually transmitted infection caused by the bacterium Treponema pallidum. It typically begins with a painless sore at the site of infection, often on the genitals, rectum, or mouth. This sore, known as a chancre, appears about three weeks after exposure and can last for several weeks. If untreated, the infection progresses to a secondary stage, characterized by skin rashes and mucous membrane lesions. These symptoms may be mild and can resolve without treatment, but the infection remains in the body. Without intervention, syphilis can progress to more severe stages, affecting various organs over time.

Trial ID:

2024-513532-23-00

Protocol code:

APHP180588

NCT ID:

NCT04838717

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Doxycycline and Benzathine Benzylpenicillin for Treating Early Syphilis in Adults

What is this study about?

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