YawsPhase 3Trep-AByawsNCT05764876

Repurposing Clinically Approved Drugs for Yaws With an Insight Into the Cutaneous Ulcer Disease Syndrome (Trep-AByaws)

A Phase 3 study testing Linezolid Oral Tablet and Azithromycin Oral Tablet in people with Yaws and Cutaneous Ulcer, run by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia at 1 site in Papua New Guinea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 5 to 18 years
Conditions the study is for: Yaws, Cutaneous Ulcer
What is being tested?: Linezolid Oral Tablet and Azithromycin Oral Tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 383 participants
Where: 1 sitePapua New Guinea
Study dates: 14 Mar 2023to 1 Dec 2024
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 5 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Participants 5-18 years identified during an active case search program at the elementary, primary and secondary schools in East New Britain,
CUD syndrome suspected due to yaws: one or more ulcerative or nodular or papilloma skin lesion of more than 1 cm in diameter.
Positive treponemal (T1) and non-treponemal (T2) serology by Chembio dual path platform (DPP) syphilis screen \& confirm assay (DPP test).
Accepted and signed informed consent.
Ability to comply with the requirements of the study protocol including follow up visits.

Who cannot join

Children younger than 5 years old.
Clinical late-stage possible yaws: destructive osteitis (rhinopharyngitis gangosa, sabre shins) or gummous nodules.
Known allergy to LZD or AZI antibiotics.
Pregnant or breastfeeding women.
Refusal at ward level or village chief (for village inclusion), or refusal of individual or guardian (for individual inclusion).
Have taken any antibiotics with potential activity against TPE within the last 7 days prior to randomization (i.e., beta lactams, cephalosporines, macrolides, tetracyclines).

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Uncontrolled hypertension, pheochromocytoma, thyrotoxicosis, carcinoid syndrome, bipolar disorder, incapacitating psycho-affective disturbance, acute confusional state.
Renal function impairment requiring hemodialysis.
Current treatment with any drugs likely to interact with the study medication
Symptomatic concomitant infection requiring antibiotic treatment potentially active against TPE.
Having received treatment for yaws in the last 6 months.
Patients who are unable to take oral medication or having a gastrointestinal disease likely to interfere with drug absorption (including malnutrition and stomach flu).

Trial locations and contacts

1 site in 1 country.

Papua New Guinea1 site

National Department of Health
Port Moresby

Other trials in Papua New Guinea

About this study

The goal of this clinical trial is to test the non inferiority of linezolid compared with azithromycin as a treatment for yaws . The main questions it aims to answer are: can linezolid cure active yaws, and can linezolid cure latent yaws. Participants with serologically confirmed yaws will be randomized to receive linezolid (experimental) or azithromycin (control group) treatment and followed up to assess clinical resolution.

Read the detailed description

The current principle of yaws eradication is based on a single round of mass drug administration of azithromycin (AZI) called total community treatment (TCT) followed by targeted treatment of active cases and close contacts every 6 months called total targeted treatment (TTT). Studies done in Papua New Guinea have shown that 3 rounds of TCT are preferable to 1 TCT followed by TTT rounds because it results in higher overall coverage, particularly of latent cases. In the context of repeated rounds of TTT and multiple rounds of TCT, resistance to AZI has ben detected on 5 patients with yaws Recent studies have been successful on the culture of Treponema pallidum (syphilis and yaws), therefore investigators are now able to identify more potential treatment for yaws and syphilis.

Yaws is one of the major causes of the Cutaneous Ulcer Disease (CUD) syndrome. The CUD syndrome is a painful and debilitating condition, endemic to remote tropical regions with poor sanitation and limited health care access affecting children mainly. In Papua New Guinea it is caused by a range of unknown and some known pathogens besides yaws that are not easily distinguished on clinical diagnosis. New information on the causative agents of the CUD syndrome is needed to facilitate its management with an integrated approach.

The aim of the project is to provide evidence supporting (or rejecting) the hypothesis that the use of linezolid (LZD) can be an alternative treatment to cure yaws corroborated by clinical, serological, and molecular methods. LZD is a very safe drug that has been delivered to adults and children for the treatment of cutaneous infections all over the world. Investigators will compare two different treatments: (A) linezolid (LZD) and (B) azithromycin (AZI). In addition, the investigators plan to contribute to characterize the etiology of the CUD syndrome. The study will be implemented in selected wards of the East New Britain Province of Papua New Guinea.

Conditions: Yaws, Cutaneous Ulcer
Being tested: Linezolid Oral Tablet, Azithromycin Oral Tablet
Keywords: azithromycin, linezolid
Medical subject headings: Yaws, Skin Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Linezolid Oral TabletDrug
Also called Zyvox, Zyvoxid
Oral tablet of linezolid
- 10mg/kg every 8 hours for 10 days for those younger than 12 and
- 600 mg every 12 h for 10 days for participants aged ≥12 years
Azithromycin Oral TabletDrug
Also called Zithromax
Oral tablet of azithromycin 30mg/kg maximum 2gr single dose.

Study groups in NCT05764876
Study group	Role	What they receive
Azithromycin	Active comparator	Participants in the control arm will receive standard treatment for yaws which azithromycin . Receives: Drug: Azithromycin Oral Tablet
Linezolid	Experimental	Participants in the experimental arm will receive oral linezolid treatment. Receives: Drug: Linezolid Oral Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

Clinical resolution
Proportion of patients with clinical resolution of yaws lesions (clinical cure). Assessment of clinical resolution defined as the complete healing of lesions at 4 weeks from treatment start.
Measured: 4 weeks after treatment
Serological cure
Proportion of patients with adequate serological response (serological cure). Assessment of sero-cure is described a negative non-treponemal line result (T2) on the Dual Path Platform (DPP) test at week 24.
Measured: 24 weeks after treatment
Relapse
Proportion of patients with relapse (recurrent episodes caused by the same strain) (molecular cure). Assessment of recurrence by molecular methods of Treponema pallidum ssp. pertenue (TPE) DNA in ulcer swab to determine relapse or reinfection within 24 weeks from treatment start.
Measured: 24 weeks after treatment

Secondary outcomes (7)

Lession (ulcer swab) TPE assessment
Assessment of TPE strains by genomic molecular methods in ulcer swabs from patients with active yaws.
Measured: Baseline (before treatment)
Oral (oral swab) TPE assessment
Assessment of TPE strains by genomic molecular methods in oral swabs from patients with active/latent yaws.
Measured: Baseline (before treatment)
Plasma TPE assessment
Assessment of TPE strains by genomic molecular methods in plasma from patients with active/latent yaws.
Measured: Baseline (before treatment)
Allelic variation in recurrent cases
Proportion of patients with allelic variation in TPE DNA in patients with recurrence or treatment failure.
Measured: Baseline (before treatment)
Identification of antibiotic resistance genotype.
Proportion of patients with antibiotic resistance genotype.
Measured: 4 weeks after treatment
Identification of other causes of cutaneous ulcer
Proportion of patients with selected known and unknown causes of cutaneous ulcers (CU). Assessment of etiological agents using polymerase chain reaction (PCR) for TPE, Haemophylus ducreyi (HD) and Streptoccocus pyogenes (SP).
Measured: Baseline (before treatment)
Safety of intervention (adverse events)
Proportion of patients with adverse events
Measured: at 4 and up to 24 weeks after treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Mar 20231 Dec 2024

First posted13 Mar 2023
Study start14 Mar 2023
Primary completion20 Jun 2024
Study completion1 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for YawsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Open-label, non inferiority, two arms and randomized clinical trial. Eligible patients will be randomized (1:1) to receive Linezolid (experimental arm) or Azithromycin (control arm).
Masking: None (open label)
Enrolment: 383 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05764876
Sponsor's protocol ID: Trep-AByaws
Acronym: Trep-AByaws
Status last verified: Oct 2026
First submitted: 2 Feb 2023
Last updated: 22 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: De-identified individual participant data underlying the results reported in the article, including the data dictionary, will be available upon reasonable request. The study protocol and statistical analysis plan will also be shared. Requests must include a methodologically sound proposal and will be considered by the study investigators, subject to ethical approval where applicable and execution of a data-sharing agreement.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Repurposing Clinically Approved Drugs for Yaws With an Insight Into the Cutaneous Ulcer Disease Syndrome (Trep-AByaws)
ClinicalTrials.gov ID: NCT05764876
Acronym / sponsor ID: Trep-AByaws / Trep-AByaws
Conditions: Yaws, Cutaneous Ulcer
Keywords: azithromycin, linezolid
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 383 participants (actual)
Lead sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la CienciaUniversity, hospital or other
Collaborators: National Department of Health, Papua New Guinea, School of Medicine and Health Sciences, University of Papua New Guinea
Study start: 14 Mar 2023 (actual)
Primary completion: 20 Jun 2024 (actual)
Study completion: 1 Dec 2024 (actual)
First posted: 13 Mar 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Open-label, non inferiority, two arms and randomized clinical trial. Eligible patients will be randomized (1:1) to receive Linezolid (experimental arm) or Azithromycin (control arm).

Arm	Type	Receives
Azithromycin	Active comparator	Drug: Azithromycin Oral TabletParticipants in the control arm will receive standard treatment for yaws which azithromycin .
Linezolid	Experimental	Drug: Linezolid Oral TabletParticipants in the experimental arm will receive oral linezolid treatment.

Who may qualify

Ages: 5 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (5 listed)

Participants 5-18 years identified during an active case search program at the elementary, primary and secondary schools in East New Britain,
CUD syndrome suspected due to yaws: one or more ulcerative or nodular or papilloma skin lesion of more than 1 cm in diameter.
Positive treponemal (T1) and non-treponemal (T2) serology by Chembio dual path platform (DPP) syphilis screen \& confirm assay (DPP test).
Accepted and signed informed consent.
Ability to comply with the requirements of the study protocol including follow up visits.

Key exclusion criteria (12 listed)

Children younger than 5 years old.
Clinical late-stage possible yaws: destructive osteitis (rhinopharyngitis gangosa, sabre shins) or gummous nodules.
Known allergy to LZD or AZI antibiotics.
Pregnant or breastfeeding women.
Refusal at ward level or village chief (for village inclusion), or refusal of individual or guardian (for individual inclusion).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Linezolid Oral TabletAlso: Zyvox, ZyvoxidOral tablet of linezolid * 10mg/kg every 8 hours for 10 days for those younger than 12 and * 600 mg every 12 h for 10 days for participants aged ≥12 years	Drug	Linezolid
Azithromycin Oral TabletAlso: ZithromaxOral tablet of azithromycin 30mg/kg maximum 2gr single dose.	Drug	Azithromycin

Primary outcome

Clinical resolution
Time frame: 4 weeks after treatment
Proportion of patients with clinical resolution of yaws lesions (clinical cure). Assessment of clinical resolution defined as the complete healing of lesions at 4 weeks from treatment start.
Serological cure
Time frame: 24 weeks after treatment
Proportion of patients with adequate serological response (serological cure). Assessment of sero-cure is described a negative non-treponemal line result (T2) on the Dual Path Platform (DPP) test at week 24.
Relapse
Time frame: 24 weeks after treatment
Proportion of patients with relapse (recurrent episodes caused by the same strain) (molecular cure). Assessment of recurrence by molecular methods of Treponema pallidum ssp. pertenue (TPE) DNA in ulcer swab to determine relapse or reinfection within 24 weeks from treatment start.

7 secondary outcomes

Lession (ulcer swab) TPE assessment
Time frame: Baseline (before treatment)
Oral (oral swab) TPE assessment
Time frame: Baseline (before treatment)
Plasma TPE assessment
Time frame: Baseline (before treatment)
Allelic variation in recurrent cases
Time frame: Baseline (before treatment)
Identification of antibiotic resistance genotype.
Time frame: 4 weeks after treatment
Identification of other causes of cutaneous ulcer
Time frame: Baseline (before treatment)
Safety of intervention (adverse events)
Time frame: at 4 and up to 24 weeks after treatment.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the article, including the data dictionary, will be available upon reasonable request. The study protocol and statistical analysis plan will also be shared. Requests must include a methodologically sound proposal and will be considered by the study investigators, subject to ethical approval where applicable and execution of a data-sharing agreement.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Camila Beiras study director

Fundació Lluita contra les Infeccions

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Papua New Guinea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical resolution (time frame: 4 weeks after treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05764876.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.