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Comparison of Two Different Doses of Azithromycin for Treatment of Yaws

Primary Purpose

Yaws

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Azithromycin
Sponsored by
London School of Hygiene and Tropical Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Yaws

Eligibility Criteria

6 Years - 16 Years (Child)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  1. Known allergy to azithromycin or macrolides.
  2. Treatment with long-acting penicillin or alternative antibiotic with activity against T. pallidum within the last 3 months (ceftriaxone, azithromycin or doxycycline, amoxicillin).
  3. Patients with current treatment with any drugs likely to interact with the study medication.
  4. Patients who are unable to take oral medication or having gastrointestinal disease likely to interfere with drug absorption.
  5. Patients who may not be able to comply with the requirements of the study protocol including follow up visits.
  6. Patients who are not willing to give informed consent (patient and/or parent/legal representative), or who withdraw consent.

Sites / Locations

  • School Based Recruitment
  • School Based Recruitment
  • School Based Recruitment
  • School Based Recruitment
  • Community Based Recruitment
  • Community Based Recruitment
  • London School of Hygiene and Tropical Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

AZT30

AZT20

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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

Full Information

First Posted
January 17, 2015
Last Updated
October 2, 2018
Sponsor
London School of Hygiene and Tropical Medicine
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, Ho, Volta Region, Ghana
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1. Study Identification

Unique Protocol Identification Number
NCT02344628
Brief Title
Comparison of Two Different Doses of Azithromycin for Treatment of Yaws
Official Title
Randomized Controlled Trial Comparing Efficacy of Single Dose Treatment of Yaws With 20mg/kg Versus 30mg/kg of Azithromycin
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
London School of Hygiene and Tropical Medicine
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, Ho, Volta Region, Ghana

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Yaws

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
583 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AZT30
Arm Type
Active Comparator
Arm Description
Single dose of azithromycin at a dose of 30mg/kg - max 2 Grams
Arm Title
AZT20
Arm Type
Experimental
Arm Description
Single dose of azithromycin at a dose of 20mg/kg - max 1 Grams
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Intervention Description
Comparison of two different dosing strategies for the treatment of yaws
Primary Outcome Measure Information:
Title
Number of Participants With Clinical and Serological Cure
Description
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.
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Number of Participants With Clinical and Serological Cure in Latent Yaws
Description
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.
Time Frame
6 Months
Title
Number of Participants With Adverse Events
Description
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
Time Frame
6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Mabey
Organizational Affiliation
London School of Hygiene and Tropical Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
School Based Recruitment
City
Ayensuanor District
State/Province
Eastern Region
Country
Ghana
Facility Name
School Based Recruitment
City
Upper West Akyem
State/Province
Eastern Region
Country
Ghana
Facility Name
School Based Recruitment
City
West Akyem District
State/Province
Eastern Region
Country
Ghana
Facility Name
School Based Recruitment
City
Nkwanta North District
State/Province
Volta Region
Country
Ghana
Facility Name
Community Based Recruitment
City
Karkar District
State/Province
Madang Province
Country
Papua New Guinea
Facility Name
Community Based Recruitment
City
Kavieng Subdistrict
State/Province
New Ireland Province
Country
Papua New Guinea
Facility Name
London School of Hygiene and Tropical Medicine
City
London
ZIP/Postal Code
WC1E 7HT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
29456191
Citation
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.
Results Reference
derived

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Comparison of Two Different Doses of Azithromycin for Treatment of Yaws

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