Can a common antibiotic beat yaws? new trial puts linezolid to the test
NCT ID NCT05764876
First seen Jun 27, 2026 · Last updated Jul 16, 2026 · Updated 2 times
Summary
This phase 3 trial investigates whether the antibiotic linezolid can cure yaws, a bacterial skin infection that causes ulcers, as effectively as the standard treatment azithromycin. The study involves 384 children aged 5 to 18 with confirmed yaws. Participants receive either linezolid for 7 days or a single dose of azithromycin, and researchers track whether their skin lesions heal and if the infection clears from the body.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Linezolid (oral tablet)
- What this could lead to
- If linezolid works as well as azithromycin, it could provide an alternative treatment for yaws, especially in areas where antibiotic resistance is a concern.
- What could go wrong
- This is a single trial with 384 participants, so results may not apply broadly. Linezolid may cause side effects like nausea or diarrhea, and it is not yet proven to be as effective as the standard treatment.
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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
-
384 people
The number who actually took part.
- Started
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Mar 2023
- Finished
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Dec 2024
- 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
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5 to 18 years
- Sex
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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 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: 1. Participants 5-18 years identified during an active case search program at the elementary, primary and secondary schools in the Islands Region. 2. CUD syndrome suspected due to yaws: one or more ulcerative or nodular or papilloma skin lesion of more than 1 cm in diameter. 3. Positive treponemal (T1) and non-treponemal (T2) serology by Chembio dual path platform (DPP) syphilis screen \& confirm assay (DPP test). 4. Accepted and signed informed consent. 5. Ability to comply with the requirements of the study protocol including follow up visits. Exclusion Criteria: 1. Children younger than 5 years old. 2. Clinical late-stage possible yaws: destructive osteitis (rhinopharyngitis gangosa, sabre shins) or gummous nodules. 3. Known allergy to LZD or AZI antibiotics. 4. Pregnant or breastfeeding women. 5. Refusal at ward level or village chief (for village inclusion), or refusal of individual or guardian (for individual inclusion). 6. Have taken any antibiotics with potential activity against TPE within the last 7 days prior to randomization (i.e., beta lactams, cephalosporines, macrolides, tetracyclines). 7. Uncontrolled hypertension, pheochromocytoma, thyrotoxicosis, carcinoid syndrome, bipolar disorder, incapacitating psycho-affective disturbance, acute confusional state. 8. Renal function impairment requiring hemodialysis. 9. Current treatment with any drugs likely to interact with the study medication 10. Symptomatic concomitant infection requiring antibiotic treatment potentially active against TPE. 11. Having received treatment for yaws in the last 6 months. 12. Patients who are unable to take oral medication or having a gastrointestinal disease likely to interfere with drug absorption (including malnutrition and stomach flu).
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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
-
National Department of Health
Port Moresby, Papua New Guinea
More trials for these conditions
Other studies related to the condition(s) this trial covers.