Clinical trial NCT02344628: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Yaws
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: World Health Organization
name: Centers for Disease Control and Prevention
name: Kwame Nkrumah University of Science and Technology
name: Barcelona Institute for Global Health
name: Papua New Guinea Institute of Medical Research
name: Ghana Health Services
name: Noguchi Memorial Institute for Medical Research
name: Papua New Guinea National Department of Health
name: University of Health and Allied Sciences
First posted: 2015-01-26
Enrollment: 583
Sex: MALE
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Participants With Clinical and Serological Cure
timeFrame: 6 Months
Secondary outcomes:
measure: Number of Participants With Clinical and Serological Cure in Latent Yaws
timeFrame: 6 Months
measure: Number of Participants With Adverse Events
timeFrame: 6 months
Other outcomes:
Locations:
city: Ayensuanor District
country: Ghana
facility: School Based Recruitment
state: Eastern Region
city: Upper West Akyem
country: Ghana
facility: School Based Recruitment
state: Eastern Region
city: West Akyem District
country: Ghana
facility: School Based Recruitment
state: Eastern Region
city: Nkwanta North District
country: Ghana
facility: School Based Recruitment
state: Volta Region
city: Karkar District
country: Papua New Guinea
facility: Community Based Recruitment
state: Madang Province
city: Kavieng Subdistrict
country: Papua New Guinea
facility: Community Based Recruitment
state: New Ireland Province
city: London
country: United Kingdom
facility: London School of Hygiene and Tropical Medicine
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: David Mabey
role: PRINCIPAL_INVESTIGATOR
References:
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.