Status:
WITHDRAWN
Safety Study of Combined Azithromycin, Ivermectin and Albendazole for Trachoma and Lymphatic Filariasis
Lead Sponsor:
Emory University
Conditions:
Trachoma
Lymphatic Filariasis
Eligibility:
All Genders
5-65 years
Phase:
PHASE4
Brief Summary
Trachoma and lymphatic filariasis (LF) are two 'Neglected Tropical Diseases' (NTDs), infectious diseases that affect millions of poor people in countries in the developing world. Trachoma is an eye in...
Eligibility Criteria
Inclusion
- Age ≥ 5 years and ≤ 65 years.
- Height ≥ 90 cm
- Able to understand the information and consent and assent forms, willing to give consent and assent, and abide by the study restrictions (parent or guardian consent if study participant age is \< 18 years, participant to assent form if age \< 18 years and ≥ 7 years)
- Residence in the study site for at least three months prior to enrolment
- Willing to remain in the study site for the duration of the study
- Willing and able to provide necessary samples to permit evaluation.
Exclusion
- Unable to swallow tablets
- History of hypersensitivity/allergy to azithromycin, ivermectin, and/or albendazole
- Treatment with another investigational agent/intervention within 4 weeks prior to study entry
- Pregnancy (demonstrated by positive urine pregnancy test, performed by study staff, or evidently pregnant). All women of child bearing age (≥ 12 years and ≤ 49 years in Nampula province, personal communication, Arlinda Martins) will undergo a urine pregnancy test (unless they are evidently pregnant) to exclude pregnancy.
- Breast-feeding mother.
- Any condition that, in the opinion of the investigator, might interfere with the outcome of the study and/or adherence to the follow up schedule, such as clinically significant illness.
Key Trial Info
Start Date :
February 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01903057
Start Date
February 1 2014
End Date
July 1 2014
Last Update
May 22 2014
Active Locations (1)
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1
National Institute of Health, Ministry of Health
Maputo, Cidade de Maputo, Mozambique