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

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ClinicalTrials.gov Identifier: NCT01903057
Recruitment Status : Withdrawn (As of November 2013, the security situation in rural Northern Mozambique is no longer suitable for this clinical trial.)
First Posted : July 19, 2013
Last Update Posted : May 22, 2014
Sponsor:
Information provided by (Responsible Party):
Huub Gelderblom MD, PhD, MPH, Emory University

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.


Condition or disease Intervention/treatment Phase
Trachoma Lymphatic Filariasis Drug: azithromycin Drug: ivermectin Drug: albendazole Drug: placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : February 2014
Estimated Primary Completion Date : March 2014
Estimated Study Completion Date : July 2014


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: 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



Primary Outcome Measures :
  1. The overall rate of adverse events and serious adverse events in each group [ Time Frame: 15 days ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]


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Ages Eligible for Study:   5 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01903057


Locations
Mozambique
National Institute of Health, Ministry of Health
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

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 ( Other Identifier: Other )
First Posted: July 19, 2013    Key Record Dates
Last Update Posted: May 22, 2014
Last Verified: May 2014

Keywords provided by Huub Gelderblom MD, PhD, MPH, Emory University:
Mass Drug Administration
Neglected Tropical Diseases
Preventive Chemotherapy and Transmission Control
Preventive Chemotherapy

Additional relevant MeSH terms:
Filariasis
Elephantiasis
Trachoma
Elephantiasis, Filarial
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
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Anticestodal Agents
Antiplatyhelmintic Agents