Safety Study of Combined Azithromycin, Ivermectin and Albendazole for Trachoma and Lymphatic Filariasis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01903057
• Date of registration: 15/07/2013
• Prospective Registration: Yes
• Primary sponsor: Emory University
• Public title: Safety Study of Combined Azithromycin, Ivermectin and Albendazole for Trachoma and Lymphatic Filariasis AZIVAL2
• Scientific title: AZIVAL 2: A Double-blind Cluster-randomized Placebo-controlled Study on the Safety of Integrated Treatment of Trachoma and Lymphatic Filariasis in Children and Adults With Azithromycin, Ivermectin and Albendazole
• Date of first enrolment: February 2014
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: http://clinicaltrials.gov/show/NCT01903057
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
• Phase: Phase 4

Countries of recruitment

Mozambique

Contacts

• Name: Huub C Gelderblom, MD, PhD, MPH
• Affiliation: Emory University

• Name: Ricardo Thompson, PhD
• Affiliation: Instituto Nacional de Saude, Ministry of Health of Mozambique

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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.



Age minimum: 5 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Trachoma

Lymphatic Filariasis

Intervention(s)

Drug: albendazole

Drug: azithromycin

Drug: ivermectin

Drug: placebo

Primary Outcome(s)

The overall rate of adverse events and serious adverse events in each group [Time Frame: 15 days]

Secondary Outcome(s)

The duration of adverse events and serious adverse events of triple combination therapy with azithromycin, ivermectin and albendazole, to standard sequential therapy. [Time Frame: 15 days]

The incidences of adverse events and serious adverse events of triple combination therapy with azithromycin, ivermectin and albendazole, to standard sequential therapy. [Time Frame: 15 days]

The intensities of adverse events and serious adverse events of triple combination therapy with azithromycin, ivermectin and albendazole, to standard sequential therapy. [Time Frame: 15 days]

The timing of adverse events and serious adverse events of triple combination therapy with azithromycin, ivermectin and albendazole, to standard sequential therapy. [Time Frame: 15 days]

The types of adverse events and serious adverse events of triple combination therapy with azithromycin, ivermectin and albendazole, to standard sequential therapy. [Time Frame: 15 days]

Secondary ID(s)

IRB00065751

ITI2012-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors