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

This study has been completed.
Sponsor:
Collaborators:
Project ORBIS
Information provided by (Responsible Party):
Sheila K West, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00347776
First received: July 3, 2006
Last updated: April 3, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Trichiasis
Drug: azithromycin
Drug: topical tetracycline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Trial of Antibiotics to Reduce Recurrent Trichiasis (STAR)

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • recurrent trichiasis [ Time Frame: 1, 2, and 3-year follow-up ] [ Designated as safety issue: No ]
    clinical assessment of one or more eyelashes touching globe


Secondary Outcome Measures:
  • surgical failure [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    clinical measure of one or more eyelashes touching globe

  • adverse events [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    any report of hospitalization, death, or clinic visit within four weeks of receiving surgery


Estimated Enrollment: 1450
Study Start Date: August 2001
Study Completion Date: December 2006
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control
topical tetracycline
Drug: topical tetracycline
Active Comparator: Intervention 1
oral azithromycin, single 1g dose to subject
Drug: azithromycin
oral antibiotic
Other Name: Zithromax
Active Comparator: Intervention 2
single oral asithromycin dose to subject and immediate family members
Drug: azithromycin
oral antibiotic
Other Name: Zithromax

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00347776

Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
Project ORBIS
Investigators
Principal Investigator: Sheila K West Johns Hopkins University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sheila K West, Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00347776     History of Changes
Other Study ID Numbers: U01EY013878
Study First Received: July 3, 2006
Last Updated: April 3, 2013
Health Authority: United States: Institutional Review Board
Ethiopia: Ethiopia Science and Technology Commission

Keywords provided by Johns Hopkins University:
trichiasis
azithromycin
trichiasis surgery
topical tetracycline

Additional relevant MeSH terms:
Trichiasis
Eyelid Diseases
Eye Diseases
Tetracycline
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014