Oral Amoxicillin Compared to Penicillin G Benzathine for the Treatment of Acquired Syphilis. (NCT06877351) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Oral Amoxicillin Compared to Penicillin G Benzathine for the Treatment of Acquired Syphilis.
Argentina120 participantsStarted 2024-08-14
Plain-language summary
The goal of this clinical trial is to learn if oral amoxicillin has comparable therapeutic response than penicillin G benzathine for the treatment of acquired pediatric syphilis. It will also learn about the adverse events and biomarkers of therapeutic response associated with oral amoxicillin. The main questions it aims to answer are:
* Does comparable therapeutic response oral amoxicillin to penicillin G benzathine in the treatment of acquired pediatric syphilis?
* Does adequate serologic response to treatment participants with syphilis when taking oral amoxicillin? Researchers will compare oral amoxicillin to intramuscular procaine benzathine penicillin to see if oral amoxicillin works similar to treat acquired pediatric syphilis.
Participants will:
* Take 40-50mg/kg oral amoxicillin every day for 14 to 21 days or an intramuscular procaine benzathine penicillin injection at a dose of 50,000 IU/kg per week for one to three weeks.
* Follow-up visits every two months after treatment until a one-year follow-up is completed.
* Keep a diary of their symptoms and the number of times they take the medications
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age up to 18 years.
. Diagnosis of primary, secondary, or early latent syphilis, based on national and international standards (16, 17, 18).
. Signed informed consent and assent.
. Ability to comply with the study protocol requirements.
. For women of childbearing potential, use of a highly effective contraceptive method (e.g., abstinence, hormonal contraception, or intrauterine device (IUD) is required. Contraception must be maintained for 1 week after the completion of treatment.
. Male participants are advised to use condoms during sexual intercourse to prevent the transmission of syphilis to their partners.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing oral amoxicillin to the standard penicillin G benzathine injection for syphilis — given that I'd be randomized to one or the other, how would that affect my treatment if the oral option turns out to be less effective for my stage of syphilis?
2Since this is a Phase 3 trial, there should be a fair amount of safety data already — what do we know so far about how the amoxicillin arm compares to the standard injection in terms of side effects or treatment failure rates?
3The trial is active but no longer recruiting, which means results may be coming soon — is it worth waiting to see those findings before deciding on my treatment approach, or does my situation require starting standard care right away?
4The primary outcome is 'therapeutic response' — can you explain what that means in practical terms for me, and how confident you are that both arms of this trial would fully clear my infection given my specific diagnosis?
5Would the standard penicillin G benzathine injection be a better first step for me right now compared to waiting or seeking out a trial like this, especially considering how quickly syphilis needs to be treated?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Therapeutic Response Criteria
Timeframe: 2 weeks to 12 months
Trial details
NCT IDNCT06877351
SponsorHospital de Niños R. Gutierrez de Buenos Aires