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Comparison of Two Different Doses of Azithromycin for Treatment of Yaws

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ClinicalTrials.gov Identifier: NCT02344628
Recruitment Status : Completed
First Posted : January 26, 2015
Results First Posted : October 3, 2018
Last Update Posted : October 31, 2018
Sponsor:
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
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

Study Description
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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.

Condition or disease Intervention/treatment Phase
Yaws Drug: Azithromycin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 583 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Comparing Efficacy of Single Dose Treatment of Yaws With 20mg/kg Versus 30mg/kg of Azithromycin
Study Start Date : June 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: AZT30
Single dose of azithromycin at a dose of 30mg/kg - max 2 Grams
 Drug: Azithromycin
Comparison of two different dosing strategies for the treatment of yaws
Experimental: AZT20
Single dose of azithromycin at a dose of 20mg/kg - max 1 Grams
 Drug: Azithromycin
Comparison of two different dosing strategies for the treatment of yaws


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Clinical and Serological Cure [ Time Frame: 6 Months ]
    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 :
  1. Number of Participants With Clinical and Serological Cure in Latent Yaws [ Time Frame: 6 Months ]
    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.

  2. Number of Participants With Adverse Events [ Time Frame: 6 months ]
    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


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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:

  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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02344628


Locations
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Ghana
School Based Recruitment
Ayensuanor District, Eastern Region, Ghana
School Based Recruitment
Upper West Akyem, Eastern Region, Ghana
School Based Recruitment
West Akyem District, Eastern Region, Ghana
School Based Recruitment
Nkwanta North District, Volta Region, Ghana
Papua New Guinea
Community Based Recruitment
Karkar District, Madang Province, Papua New Guinea
Community Based Recruitment
Kavieng Subdistrict, New Ireland Province, Papua New Guinea
United Kingdom
London School of Hygiene and Tropical Medicine
London, United Kingdom, WC1E 7HT
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
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
Investigators
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Principal Investigator: David Mabey London School of Hygiene and Tropical Medicine
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT02344628    
Other Study ID Numbers: LSHTM-8832
First Posted: January 26, 2015    Key Record Dates
Results First Posted: October 3, 2018
Last Update Posted: October 31, 2018
Last Verified: October 2016
Additional relevant MeSH terms:
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Yaws
Treponemal Infections
Spirochaetales Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections
 Skin Diseases, Bacterial
Skin Diseases, Infectious
Skin Diseases
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents