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Completed

NCT Number: NCT02344628

Comparison of Two Different Doses of Azithromycin for Treatment of Yaws

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.

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Key information

Conditions

Yaws Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Spirochaetales Infections Treponemal Infections

Age range

6 year–16 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

School Based Recruitment, Ayensuanor District, Eastern Region, Ghana

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Azithromycin

Drug

Comparison of two different dosing strategies for the treatment of yaws

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

London School of Hygiene and Tropical Medicine

Other

Collaborators

  • Barcelona Institute for Global Health
  • Centers for Disease Control and Prevention
  • Ghana Health Services
  • Kwame Nkrumah University of Science and Technology
  • Noguchi Memorial Institute for Medical Research
  • Papua New Guinea Institute of Medical Research
  • Papua New Guinea National Department of Health
  • University of Health and Allied Sciences
  • World Health Organization

Registry information

Official study title

Randomized Controlled Trial Comparing Efficacy of Single Dose Treatment of Yaws With 20mg/kg Versus 30mg/kg of Azithromycin

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 26, 2015
Registry last updated
Oct 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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