Study of Azithromycin to Prevent Recurrent Trichiasis Following Surgery in Ethiopia (STAR)

June 27, 2017 updated by: Johns Hopkins University

Trial of Antibiotics to Reduce Recurrent Trichiasis (STAR)

Trachoma, an ocular infection caused by C. trachomatis, is the second leading cause of blindness worldwide.Years of repeated infection with C. trachomatis cause the eyelid to scar and contract and ultimately to rotate inward such that eyelashes rub against the eyeball and abrade the cornea (trichiasis). The World Health Organization (WHO) has endorsed a multi-faceted strategy to combat trachoma, which includes surgery to correct trichiasis. Despite this encouraging news, under the best of circumstances the recurrence rate of trichiasis following surgery is disappointingly high. The objective of our project is to conduct a randomized, controlled clinical trial of post-surgical antibiotic treatment, comparing oral azithromycin to topical tetracycline, for trichiasis surgical patients in Ethiopia with the goal of determining the impact of treatment on rates of trichiasis recurrence at one and two years.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A randomized clinical trial of the effectiveness of a single dose of azithromycin compared to 6 weeks of topical tetracycline, and the added benefit of family-based azithromycin treatment, in preventing recurrence of trichiasis following surgery is proposed. This will provide the evidence base to inform and change the global public health policy and the donation program policy, regarding post-surgical treatment for trichiasis patients and possibly their families.

The investigators will determine the impact of three treatment strategies following trichiasis surgery on the rate of trichiasis recurrence in the operated eye at six months and one year. A randomized clinical trial of 1425 trichiasis surgical patients will be conducted in Sodo,Ethiopia. The first group (Control Group) will receive topical tetracycline following surgery; the second group (Intervention Patient Group) will receive oral azithromycin; the third group (Intervention Family Group) will receive oral azithromycin, and all family members resident in the patient's household will also receive oral azithromycin. Data will be collected at baseline (pre-surgery) on ocular status and infection status. Data will be collected at the time of surgery on surgery-related variables and surgical and post-operative complications. Additional data will be collected on any surgical complications and early recurrence at the two-week visit when sutures will be removed. A follow up visit at two months will include data collection on recurrence and presence of ocular infection. Evaluations for trichiasis recurrence will occur again at six months and at one year post-surgery. The latter visit will also include data collection on presence of ocular infection in the surgical case, and ocular infection in household members. Evaluation of the risk of recurrence at six months and one, two, and three years within each group will be completed to determine the benefit of using azithromycin compared to topical tetracycline, and the added benefit of family-based treatment.

Study Type

Interventional

Enrollment (Actual)

1452

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Presence of trichiasis:
  • no previous report of trichiasis surgery in at least one eye with trichiasis:
  • Agreement by at least one other family member accompanying the patient that, if the patient is randomized to the family-treatment arm, s/he also would be willing to receive antibiotic treatment
  • Age 18 or older

Exclusion Criteria:

  • other household members concurrently participating in the trial
  • Self-reported pregnancy
  • Documented allergy to tetracycline
  • Plans to move out of the region within 1 year.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
topical tetracycline
Drug: topical tetracycline
Active Comparator: Intervention 1
oral azithromycin, single 1g dose to subject
Drug: azithromycin
oral antibiotic
Other Names:
  • Zithromax
Active Comparator: Intervention 2
single oral azithromycin dose to subject and immediate family members
Drug: azithromycin
oral antibiotic
Other Names:
  • Zithromax

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrent Trichiasis in Tetracycline and Azithromycin Groups
Time Frame: Primary outcome assessed at 2 weeks,1.5 months, 6 months and 12 months post-surgery
Recurrence of trichiasis : Clinical assessment was done by looking for one or more eye lashes touching globe or evidence of epilation.
Primary outcome assessed at 2 weeks,1.5 months, 6 months and 12 months post-surgery
Recurrent Trichiasis Between Two Azithromycin Arms
Time Frame: Primary outcome assessed at 2 weeks,1.5 months, 6 months and 12 months post-surgery

Recurrence of trichiasis :Clinical assessment for recurrence was done by looking for one or more eye lashes touching globe or evidence of epilation.

If there was evidence of epilation or if one or more eye lashes were touching the globe, it was considered as recurrence of trichiasis.
Primary outcome assessed at 2 weeks,1.5 months, 6 months and 12 months post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical Failure
Time Frame: 6 weeks
The surgery was considered a failure if one or more eye lashes were touching the globe of the eye of the subject.
6 weeks
Adverse Events
Time Frame: 6 weeks
At 6 weeks participants/family members were asked about any hospitalization,death,ocular complaints, gastrointestinal illness or other specific illness or any clinic visit within six weeks of receiving surgery.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Eye Institute (NEI)
Project ORBIS

Investigators

  • Principal Investigator: Sheila K West, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2001

Primary Completion (Actual)

December 1, 2003

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

July 3, 2006

First Submitted That Met QC Criteria

July 3, 2006

First Posted (Estimate)

July 4, 2006

Study Record Updates

Last Update Posted (Actual)

August 7, 2017

Last Update Submitted That Met QC Criteria

June 27, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U01EY013878 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Trichiasis

Clinical Trials on topical tetracycline

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo, DR of

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe