YawsPhase 3NCT02344628
Comparison of Two Different Doses of Azithromycin for Treatment of Yaws
A Phase 3 study testing Azithromycin in people with Yaws, run by London School of Hygiene and Tropical Medicine at 7 sites in 3 countries.
Trial summary
The study will be a single blinded, randomized, controlled open label non-inferiority phase III, trial with two parallel groups, conducted in Ghana and Papua New Guinea (PNG). The ultimate goal is to establish if a 20mg/kg dose of azithromycin is as effective as a 30mg/kg dose in the treatment of yaws. Read more about this study
- Who is it for?
- Ages 6 to 16 years, men only
- Conditions the study is for
- Yaws
- What is being tested?
- Azithromycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 583 participants
- Where
- 7 sitesin 3 countries
- Study dates
- Jun 2015to Dec 2016
- Phase
- Phase 3
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 6 to 16 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Aged 6 to 16 years
- Clinical lesion consistent with primary or secondary yaws -Primary ulcer or papilloma
- Dually-Positive Chembio DPP Syphilis Screen \& Confirm
- Informed Consent and Assent (for children 12-16 years)
Who cannot join
- Known allergy to azithromycin or macrolides.
- Treatment with long-acting penicillin or alternative antibiotic with activity against T. pallidum within the last 3 months (ceftriaxone, azithromycin or doxycycline, amoxicillin).
- Patients with current treatment with any drugs likely to interact with the study medication.
- Patients who are unable to take oral medication or having gastrointestinal disease likely to interfere with drug absorption.
- Patients who may not be able to comply with the requirements of the study protocol including follow up visits.
- Patients who are not willing to give informed consent (patient and/or parent/legal representative), or who withdraw consent.
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Ghana4 sites
School Based Recruitment
Ayensuanor District, Eastern Region
School Based Recruitment
Nkwanta North District, Volta Region
School Based Recruitment
Upper West Akyem, Eastern Region
School Based Recruitment
West Akyem District, Eastern Region
Papua New Guinea2 sites
Community Based Recruitment
Karkar District, Madang Province
Community Based Recruitment
Kavieng Subdistrict, New Ireland Province
United Kingdom1 site
London School of Hygiene and Tropical Medicine
London, WC1E 7HT
About this study
Official title: Randomized Controlled Trial Comparing Efficacy of Single Dose Treatment of Yaws With 20mg/kg Versus 30mg/kg of Azithromycin
The study will be a single blinded, randomized, controlled open label non-inferiority phase III, trial with two parallel groups, conducted in Ghana and Papua New Guinea (PNG). The ultimate goal is to establish if a 20mg/kg dose of azithromycin is as effective as a 30mg/kg dose in the treatment of yaws. Approximately 600 clinically and serologically diagnosed yaws patients will be included in the study. Patients will be randomized to receive treatment with the two antibiotic regimens as follow: (i) Regimen I (AZT20): Single oral dose of 20 mg/kg azithromycin (ii) Regimen II (AZT30): Single oral dose of 30 mg/kg azithromycin. The follow-up period of patients will be 6 months. Assessments before, during and after the antibiotic treatment will include full medical history, clinical assessment of the lesion and, laboratory investigations. The primary efficacy parameters are healing of the lesion at 4 weeks and a four-fold decline in RPR titre at 6 months after start of treatment.
- Conditions
- Yaws
- Being tested
- Azithromycin
- Medical subject headings
- Yaws
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
Comparison of two different dosing strategies for the treatment of yaws
| Study group | Role | What they receive |
|---|---|---|
| AZT30 | Active comparator | Single dose of azithromycin at a dose of 30mg/kg - max 2 Grams Receives: Drug: Azithromycin |
| AZT20 | Experimental | Single dose of azithromycin at a dose of 20mg/kg - max 1 Grams Receives: Drug: Azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Clinical and Serological Cure
Clinical resolution of skin lesion at 4 weeks and at least four-fold decline in Rapid Plasma Reagin titre or seroreversion at 6-month (compared to baseline) in T.pallidum subsp. pertenue Polymerase Chain Reaction-confirmed subjects with yaws.
Measured: 6 Months
Secondary outcomes (2)
Number of Participants With Clinical and Serological Cure in Latent Yaws
Clinical resolution of skin lesion at 4 weeks and at least four-fold decline in Rapid Plasma Reagin titre or seroreversion at 6-month (compared to baseline) in T.pallidum subsp. pertenue Polymerase Chain Reaction-negative.
Measured: 6 Months
Number of Participants With Adverse Events
To compare the incidences and relative risk of all Adverse Events (AEs), including treatment-related AEs, Serious Adverse Events (SAEs) and grade 3-4 toxicity in patients treated with AZT20 and AZT30 regimens
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Masking
- None (open label)
- Enrolment
- 583 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization, Centers for Disease Control and Prevention, Kwame Nkrumah University of Science and Technology, Barcelona Institute for Global Health, Papua New Guinea Institute of Medical Research, Ghana Health Services, Noguchi Memorial Institute for Medical Research, Papua New Guinea National Department of Health, University of Health and Allied Sciences
- Responsible party
- Sponsor
- Investigators
- David Mabey, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02344628
- Sponsor's protocol ID
- LSHTM-8832
- Status last verified
- Oct 2016
- First submitted
- 17 Jan 2015
- Last updated
- 31 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Marks M, Mitja O, Bottomley C, Kwakye C, Houinei W, Bauri M, Adwere P, Abdulai AA, Dua F, Boateng L, Wangi J, Ohene SA, Wangnapi R, Simpson SV, Miag H, Addo KK, Basing LA, Danavall D, Chi KH, Pillay A, Ballard R, Solomon AW, Chen CY, Bieb SV, Adu-Sarkodie Y, Mabey DCW, Asiedu K; study team. Comparative efficacy of low-dose versus standard-dose azithromycin for patients with yaws: a randomised non-inferiority trial in Ghana and Papua New Guinea. Lancet Glob Health. 2018 Apr;6(4):e401-e410. doi: 10.1016/S2214-109X(18)30023-8. Epub 2018 Feb 16.
PubMed 29456191