NCT00347607

Brief Summary

After single, yearly, mass treatment of communities with azithromycin for active trachoma, what is the added effectiveness for reduction of trachoma and ocular C. trachomatis infection at one, two, and three years, relative to the added costs, of community-based surveillance and treatment of cases of severe trachoma (TI) semi-annually or every 4 months?

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,700

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2002

Longer than P75 for phase_4

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
Last Updated

October 28, 2011

Status Verified

March 1, 2002

First QC Date

July 3, 2006

Last Update Submit

October 27, 2011

Conditions

Trachoma

Keywords

trachomachlamydia trachomatissurveillanceazithromycin

Outcome Measures

Primary Outcomes (2)

  • trachoma

  • ocular C. trachomatis

Interventions

community surveillance and re-treatmentBEHAVIORAL

Eligibility Criteria

Age12 Months - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • villages not in the Tanzania National Trachoma control Program in Kongwa, Tanzania
  • villages with population size less than 5,000
  • sentinel children: ages 1 year to 7 years

You may not qualify if:

  • Village leadership refuses to allow village participation
  • sentinel children: previous history of treatment with azithromycin
  • sentinel children: another family member (child)already enrolled in study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Johns Hopkins university

Baltimore, Maryland, 21205, United States

Location

Kongwa Trachoma Project

Kongwa, Dodoma, Tanzania

Location

MeSH Terms

Conditions

Trachoma

Condition Hierarchy (Ancestors)

Conjunctivitis, BacterialEye Infections, BacterialBacterial InfectionsBacterial Infections and MycosesInfectionsChlamydia InfectionsChlamydiaceae InfectionsGram-Negative Bacterial InfectionsEye InfectionsConjunctivitisConjunctival DiseasesEye DiseasesCorneal Diseases

Study Officials

  • Sheila K West

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 3, 2006

First Posted

July 4, 2006

Study Start

April 1, 2002

Study Completion

November 1, 2005

Last Updated

October 28, 2011

Record last verified: 2002-03

Locations

US(1)TA(1)