Comparison of Two Different Doses of Azithromycin for Treatment of Yaws

NCT ID: NCT02344628

Last Updated: 2018-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 583 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2016-12-31

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.

Conditions

Yaws

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AZT30

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

Group Type: ACTIVE_COMPARATOR

Azithromycin

Intervention Type: DRUG

Comparison of two different dosing strategies for the treatment of yaws

AZT20

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

Group Type: EXPERIMENTAL

Azithromycin

Intervention Type: DRUG

Comparison of two different dosing strategies for the treatment of yaws

Interventions

Azithromycin

Comparison of two different dosing strategies for the treatment of yaws

Intervention Type: DRUG

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

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

World Health Organization

OTHER

Sponsor Role: collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

Kwame Nkrumah University of Science and Technology

OTHER

Sponsor Role: collaborator

Barcelona Institute for Global Health

OTHER

Sponsor Role: collaborator

Papua New Guinea Institute of Medical Research

OTHER_GOV

Sponsor Role: collaborator

Ghana Health Services

OTHER_GOV

Sponsor Role: collaborator

Noguchi Memorial Institute for Medical Research

OTHER

Sponsor Role: collaborator

Papua New Guinea National Department of Health

UNKNOWN

Sponsor Role: collaborator

University of Health and Allied Sciences

OTHER

Sponsor Role: collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Mabey

Role: PRINCIPAL_INVESTIGATOR

London School of Hygiene and Tropical Medicine

Locations

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

Community Based Recruitment

Karkar District, Madang Province, Papua New Guinea

Community Based Recruitment

Kavieng Subdistrict, New Ireland Province, Papua New Guinea

London School of Hygiene and Tropical Medicine

London, , United Kingdom

Countries

Ghana; Papua New Guinea; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 29456191 (View on PubMed)

Other Identifiers

LSHTM-8832

Identifier Type: -

Identifier Source: org_study_id