Trial record 11 of 21 for:    "Trachoma"

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

This study is not yet open for participant recruitment.
Verified November 2013 by Emory University
Sponsor:
Information provided by (Responsible Party):
Huub Gelderblom MD, PhD, MPH, Emory University
ClinicalTrials.gov Identifier:
NCT01903057
First received: July 15, 2013
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Trachoma
Lymphatic Filariasis
Drug: azithromycin
Drug: ivermectin
Drug: albendazole
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • The overall rate of adverse events and serious adverse events in each group [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 3680
Study Start Date: February 2014
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: azithromycin Drug: ivermectin Drug: albendazole Drug: placebo
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: azithromycin Drug: ivermectin Drug: albendazole Drug: placebo

  Eligibility

Ages Eligible for Study:   5 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01903057

Contacts
Contact: Huub C Gelderblom, MD, PhD, MPH +19144143112 hgelderblom@taskforce.org, huubcgelderblom@gmail.com

Locations
Mozambique
National Institute of Health, Ministry of Health Not yet recruiting
Maputo, Mozambique
Sponsors and Collaborators
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
  More Information

Publications:
Responsible Party: Huub Gelderblom MD, PhD, MPH, Associate Director, Emory University
ClinicalTrials.gov Identifier: NCT01903057     History of Changes
Other Study ID Numbers: IRB00065751, ITI2012-001
Study First Received: July 15, 2013
Last Updated: November 19, 2013
Health Authority: Mozambique: Ministry of Health (MISAU)
United States: Institutional Review Board
United States: Data and Safety Monitoring Board

Keywords provided by Emory University:
Mass Drug Administration
Neglected Tropical Diseases
Preventive Chemotherapy and Transmission Control
Preventive Chemotherapy

Additional relevant MeSH terms:
Trachoma
Elephantiasis, Filarial
Elephantiasis
Filariasis
Spirurida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Lymphedema
Lymphatic Diseases
Conjunctivitis, Bacterial
Eye Infections, Bacterial
Bacterial Infections
Chlamydia Infections
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Eye Infections
Infection
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Albendazole
Ivermectin
Azithromycin
Anticestodal Agents
Antiplatyhelmintic Agents
Anthelmintics
Antiparasitic Agents

ClinicalTrials.gov processed this record on April 17, 2014