Safety Study of Combined Azithromycin, Ivermectin and Albendazole for Trachoma and Lymphatic Filariasis (AZIVAL2)

May 21, 2014 updated by: Huub Gelderblom MD, PhD, MPH, Emory University

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

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 infection that can lead to painful scarring of the eyelids and blindness later in life. LF can lead to swelling of usually the limbs (elephantiasis).

Trachoma and LF are preventable and treatable diseases. One important treatment strategy is annual Mass Drug Administration (MDA): Communities receive drug treatment once a year. Azithromycin is given for trachoma. Ivermectin and albendazole are given for LF.

Trachoma MDA and LF MDA are currently separated campaigns. Combined MDA campaigns for trachoma and LF, where three drugs would be given at one time, would reduce costs and decrease the burden on the health system.

Before combined MDA with three drugs (azithromycin, ivermectin and albendazole) could be recommended, we would have to demonstrate that the safety profile of this treatment with three drugs is acceptable. An earlier study in Mali in 2010 (AZIVAL) comparing standard MDA (one week space between the two MDA campaigns) with combined MDA (trachoma and LF MDA on the same day) showed that the safety profiles were comparable; but the results of the study were not statistically significant and we could not use them to make an official recommendation.

The AZIVAL 2 study has been designed to answer the questions that remain after the AZIVAL study performed in Mali in 2010. If the safety results of the AZIVAL 2 study are acceptable, an official recommendation for combined MDA with azithromycin, ivermectin and albendazole can be drafted.

We will conduct the AZIVAL 2 study in Mozambique. The target population (inclusion and exclusion criteria) is the same as in the AZIVAL study in Mali. Main criteria are: Age ≥ 5 years and ≤ 65 years, height ≥ 90 cm, if female, not pregnant or breast-feeding.

Important differences between the AZIVAL study and the AZIVAL 2 study are a) smaller clusters for sufficient power (average household size is 5 people), b) placebo to double-blind participants and study staff for azithromycin, c) the study area will have undergone fewer previous rounds of MDA for LF and none for trachoma, and d) smartphones for data entry.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mozambique
      • Maputo, Mozambique
        • National Institute of Health, Ministry of Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 65 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Combination treatment

Combination treatment with azithromycin, ivermectin and albendazole on day 1, followed by placebo on day 8

Placebo has same appearance and dosing as azithromycin.
Drug: placebo
Drug: azithromycin
Drug: ivermectin
Drug: albendazole
PLACEBO_COMPARATOR: Control (Standard of Care)

Standard treatment with placebo, ivermectin and albendazole on day 1, followed by azithromycin on day 8

Placebo has same appearance and dosing as azithromycin.
Drug: placebo
Drug: azithromycin
Drug: ivermectin
Drug: albendazole

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
15 days
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
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
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Investigators

  • Principal Investigator: Huub C Gelderblom, MD, PhD, MPH, Emory University
  • Principal Investigator: Ricardo Thompson, PhD, Instituto Nacional de Saude, Ministry of Health of Mozambique

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (ANTICIPATED)

March 1, 2014

Study Completion (ANTICIPATED)

July 1, 2014

Study Registration Dates

First Submitted

July 15, 2013

First Submitted That Met QC Criteria

July 18, 2013

First Posted (ESTIMATE)

July 19, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

May 22, 2014

Last Update Submitted That Met QC Criteria

May 21, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00065751
  • ITI2012-001 (OTHER: Other)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lymphatic Filariasis

Clinical Trials on placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Luxembourg

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe