Trial record 9 of 21 for:    "Trachoma"

Azithromycin in Control of Trachoma II

This study has been withdrawn prior to enrollment.
(Prevalence of infection for screened population too low (<7%) to enroll anyone.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Julius Schachter, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00286026
First received: January 31, 2006
Last updated: April 12, 2012
Last verified: April 2012
  Purpose

Trachoma is the world's leading cause of preventable blindness. This disease, caused by Chlamydia trachomatis, is endemic in many parts of the developing world. In 1990s we evaluated the use of community-wide treatment with oral azithromycin in a project called Azithromycin in Control of Trachoma (ACT). This approach resulted in clinical improvement and dramatic reduction in prevalence of chlamydial infection through a 1-year follow-up. We enrolled the ACT villages, as well as an additional village that had not had any prior treatments, in our ACT II (2005) study and performed clinical surveys to assess trachoma activity testing conjunctival swabs for the presence of C. trachomatis by nucleic acid amplification tests (NAATs). Thus, we hoped to determine the long-term (10 year) effects of azithromycin treatment.

We have completed the census and clinical survey of the initial three villages. Mass treatment with azithromycin would not be justified with such low rates (1.8 - 4%) of ocular chlamydial infection. We have treated only those living in households with one or more cases of chlamydial infection and we will not follow up on these individually treated families.

In order to achieve the goals of our study, we now propose to identify other more remote villages with trachoma infection rates of 20% or more to evaluate the effect of community-wide treatment with single dose of oral azithromycin. If one or more of these villages (dependent upon population) has trachoma rates of 20% or more they will be invited to participate in the azithromycin treatment. In one set of subjects (1 or 2 villages, dependent upon population and infection rate) we will perform treatment, and follow them up at 2-, 12-, and 24-months post-treatment to ascertain infection rates. In a second set of subjects (1 or 2 villages, dependent upon population and infection rate) we will perform treatment, then perform re-treatment at 30-days post initial treatment, and follow them up at 2-, 12-, and 24-months post-treatment to ascertain infection rates. This should help us determine the need for/and the best time for re-treatment to eliminate blinding trachoma, as some recent studies suggest there is a 2-4% failure rate in the initial treatment. In sum, this study should provide a rational approach to use of community-wide azithromycin treatment to eliminate blinding trachoma as a public health problem


Condition Intervention Phase
Trachoma
Drug: Azithromycin
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Azithromycin in Control of Trachoma II

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Infection with Chlamydia trachomatis diagnosed by use of NAAT [ Time Frame: One-year ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: June 2005
Study Completion Date: August 2009
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Subjects residing in villages assigned to treatment arm 1 will receive a clinical evaluation for trachoma and provide a swab specimen of conjunctivae of the R eye at enrollment (Day 0); will be treated with Azithromycin at Day 30; will be re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
Drug: Azithromycin
1 gm Azithromycin orally, provided as four 250 mg tablets for adults; pediatric suspension will be provided to children > 1 year old (20 mg/kg body weight) to a maximal dose of 500 mg. One dose vs 2 doses given 30 days apart.
Other Names:
  • Zithromax
  • Zmax
Experimental: Arm 2
Subjects residing in villages assigned to treatment arm 2 will receive a clinical evaluation for trachoma and provide a swab specimen of conjunctivae of the R eye at enrollment (Day 0), as well as receive an initial treatment with Azithromycin; will receive a second dose of Azithromycin at Day 30; will be re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
Drug: Azithromycin
1 gm Azithromycin orally, provided as four 250 mg tablets for adults; pediatric suspension will be provided to children > 1 year old (20 mg/kg body weight) to a maximal dose of 500 mg. One dose vs 2 doses given 30 days apart.
Other Names:
  • Zithromax
  • Zmax

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Person resides within a selected rural village in a trachoma-endemic area of Egypt.

Exclusion Criteria:

  • Person does not reside in one of the three rural villages being studied.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00286026

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Julius Schachter, PhD University of California, San Francisco
Principal Investigator: Chandler R Dawson, MD University of California, San Francisco
  More Information

Publications:

Responsible Party: Julius Schachter, Professor of Laboratory Medicine, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00286026     History of Changes
Other Study ID Numbers: H1079-17254, 5R01AI048789
Study First Received: January 31, 2006
Last Updated: April 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Chlamydia trachomatis

Additional relevant MeSH terms:
Trachoma
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
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014