Comparison of Two Different Doses of Azithromycin for Treatment of Yaws

Yaws Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02344628
• Other study ID #: LSHTM-8832
• Status: Completed
• Phase: Phase 3
• Start date: June 2015
• Est. completion date: December 2016

Study information

• Verified date: October 2016
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 583
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 6 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Yaws

Intervention

Drug:
• Azithromycin
Comparison of two different dosing strategies for the treatment of yaws

Locations

Country	Name	City	State
Ghana	School Based Recruitment	Ayensuanor District	Eastern Region
Ghana	School Based Recruitment	Nkwanta North District	Volta Region
Ghana	School Based Recruitment	Upper West Akyem	Eastern Region
Ghana	School Based Recruitment	West Akyem District	Eastern Region
Papua New Guinea	Community Based Recruitment	Karkar District	Madang Province
Papua New Guinea	Community Based Recruitment	Kavieng Subdistrict	New Ireland Province
United Kingdom	London School of Hygiene and Tropical Medicine	London

Sponsors (10)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	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, Ho, Volta Region, Ghana, World Health Organization

Countries where clinical trial is conducted

Ghana,  Papua New Guinea,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	6 Months
Secondary	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	6 months