NCT02344628

Brief 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. 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
583

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2015

Geographic Reach
3 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 26, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

October 3, 2018

Completed
Last Updated

October 31, 2018

Status Verified

October 1, 2016

Enrollment Period

1.5 years

First QC Date

January 17, 2015

Results QC Date

January 19, 2018

Last Update Submit

October 2, 2018

Conditions

Yaws

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 Months

Secondary Outcomes (2)

  • Number of Participants With Clinical and Serological Cure in Latent Yaws

    6 Months

  • Number of Participants With Adverse Events

    6 months

Study Arms (2)

AZT30

ACTIVE COMPARATOR

Single dose of azithromycin at a dose of 30mg/kg - max 2 Grams

Drug: Azithromycin

AZT20

EXPERIMENTAL

Single dose of azithromycin at a dose of 20mg/kg - max 1 Grams

Drug: Azithromycin

Interventions

AzithromycinDRUG

Comparison of two different dosing strategies for the treatment of yaws

AZT20AZT30

Eligibility Criteria

Age6 Years - 16 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

School Based Recruitment

Ayensuanor District, Eastern Region, Ghana

Location

School Based Recruitment

Upper West Akyem, Eastern Region, Ghana

Location

School Based Recruitment

West Akyem District, Eastern Region, Ghana

Location

School Based Recruitment

Nkwanta North District, Volta Region, Ghana

Location

Community Based Recruitment

Karkar District, Madang Province, Papua New Guinea

Location

Community Based Recruitment

Kavieng Subdistrict, New Ireland Province, Papua New Guinea

Location

London School of Hygiene and Tropical Medicine

London, WC1E 7HT, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 29456191DERIVED

MeSH Terms

Conditions

Yaws

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Treponemal InfectionsSpirochaetales InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSkin Diseases, BacterialSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Results Point of Contact

Title
Dr Michael Marks
Organization
London School of Hygiene and Tropical Medicine
michael.marks@lshtm.ac.uk
+447984643424

Study Officials

  • David Mabey

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2015

First Posted

January 26, 2015

Study Start

June 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

October 31, 2018

Results First Posted

October 3, 2018

Record last verified: 2016-10

Locations

GB(1)GH(4)PA(2)