Study of Azithromycin to Prevent Recurrent Trichiasis Following Surgery in Ethiopia - Full Text View

Sponsor:	Johns Hopkins University
Collaborators:	National Eye Institute (NEI) Project ORBIS
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00347776

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	Phase IV

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

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics

Drug Information available for: Azithromycin

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

recurrent trichiasis

Secondary Outcome Measures:

surgical failure
adverse events

Estimated Enrollment:	1450
Study Start Date:	August 2001
Estimated Study Completion Date:	December 2006

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.

We 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. To achieve our objectives, 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 year 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

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

National Eye Institute (NEI)

Project ORBIS

Investigators

Principal Investigator:

Sheila K West

Johns Hopkins University

More Information

Publications:

West SK, West ES, Alemayehu W, Melese M, Munoz B, Imeru A, Worku A, Gaydos C, Meinert CL, Quinn T. Single-dose azithromycin prevents trichiasis recurrence following surgery: randomized trial in Ethiopia. Arch Ophthalmol. 2006 Mar;124(3):309-14.

Melese M, West ES, Alemayehu W, Munoz B, Worku A, Gaydos CA, West SK. Characteristics of trichiasis patients presenting for surgery in rural Ethiopia. Br J Ophthalmol. 2005 Sep;89(9):1084-8.

West ES, Munoz B, Imeru A, Alemayehu W, Melese M, West SK. The association between epilation and corneal opacity among eyes with trachomatous trichiasis. Br J Ophthalmol. 2006 Feb;90(2):171-4.

West ES, Alemayehu W, Munoz B, Melese M, Imeru A, West SK. Surgery for Trichiasis, Antibiotics to prevent Recurrence (STAR) Clinical Trial methodology. Ophthalmic Epidemiol. 2005 Aug;12(4):279-86.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gower EW, Merbs SL, Munoz BE, Kello AB, Alemayehu W, Imeru A, West SK. Rates and risk factors for unfavorable outcomes 6 weeks after trichiasis surgery. Invest Ophthalmol Vis Sci. 2011 Apr 25;52(5):2704-11. Print 2011 Apr.

Woreta TA, Munoz BE, Gower EW, Alemayehu W, West SK. Effect of trichiasis surgery on visual acuity outcomes in Ethiopia. Arch Ophthalmol. 2009 Nov;127(11):1505-10.

ClinicalTrials.gov Identifier:	NCT00347776 History of Changes
Other Study ID Numbers:	U01EY013878
Study First Received:	July 3, 2006
Last Updated:	July 3, 2006
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
Azithromycin

Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 07, 2012