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

Brief Title

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

Official 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

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 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 Phase

Phase 4

Study Type

Interventional

Primary Outcome

The overall rate of adverse events and serious adverse events in each group

Secondary Outcome

 The types of adverse events and serious adverse events of triple combination therapy with azithromycin, ivermectin and albendazole, to standard sequential therapy.

Condition

Trachoma

Intervention

azithromycin

Study Arms / Comparison Groups

 Combination treatment

Description:  Combination treatment with azithromycin, ivermectin and albendazole on day 1, followed by placebo on day 8
Placebo has same appearance and dosing as azithromycin.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

0

Start Date

February 2014

Completion Date

July 2014

Primary Completion Date

March 2014

Eligibility 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.
      

Gender

All

Ages

5 Years - 65 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Huub C Gelderblom, MD, PhD, MPH, , 

Location Countries

Mozambique

Location Countries

Mozambique

NCT ID

NCT01903057

Organization ID

IRB00065751

Secondary IDs

ITI2012-001

Responsible Party

Principal Investigator

Study Sponsor

Emory University

Study Sponsor

Huub C Gelderblom, MD, PhD, MPH, Principal Investigator, Emory University

Verification Date

May 2014