NCT00347776

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,452

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2001

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed
2.6 years 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
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
10.7 years until next milestone

Results Posted

Study results publicly available

August 7, 2017

Completed
Last Updated

August 7, 2017

Status Verified

June 1, 2017

Enrollment Period

2.3 years

First QC Date

July 3, 2006

Results QC Date

April 13, 2017

Last Update Submit

June 27, 2017

Conditions

Trichiasis

Keywords

trichiasisazithromycintrichiasis surgerytopical tetracycline

Outcome Measures

Primary Outcomes (2)

  • Recurrent Trichiasis in Tetracycline and Azithromycin Groups

    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

    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 Outcomes (2)

  • Surgical Failure

    6 weeks

  • Adverse Events

    6 weeks

Study Arms (3)

Control

ACTIVE COMPARATOR

topical tetracycline

Drug: topical tetracycline

Intervention 1

ACTIVE COMPARATOR

oral azithromycin, single 1g dose to subject

Drug: azithromycin

Intervention 2

ACTIVE COMPARATOR

single oral azithromycin dose to subject and immediate family members

Drug: azithromycin

Interventions

azithromycinDRUG

oral antibiotic

Also known as: Zithromax
Intervention 1Intervention 2
topical tetracyclineDRUG
Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Related Publications (7)

  • 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. doi: 10.1136/bjo.2005.066076.

    PMID: 16113353BACKGROUND

  • 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. doi: 10.1136/bjo.2005.075390.

    PMID: 16424528BACKGROUND

  • 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. doi: 10.1080/09286580591005769.

    PMID: 16033749BACKGROUND

  • 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. doi: 10.1001/archopht.124.3.309.

    PMID: 16534049RESULT

  • Woreta F, Munoz B, Gower E, Alemayehu W, West SK. Three-year outcomes of the surgery for trichiasis, antibiotics to prevent recurrence trial. Arch Ophthalmol. 2012 Apr;130(4):427-31. doi: 10.1001/archophthalmol.2011.374. Epub 2011 Dec 12.

    PMID: 22159169DERIVED

  • 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. doi: 10.1167/iovs.10-5161. Print 2011 Apr.

    PMID: 21051704DERIVED

  • 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. doi: 10.1001/archophthalmol.2009.278.

    PMID: 19901217DERIVED

MeSH Terms

Conditions

Trichiasis

Interventions

AzithromycinTetracycline

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic ChemicalsTetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Limitations and Caveats

1.Azithromycin administered was observed.Compliance was 100%.In tetracycline group,only 1st application of ointment was observed.Data on compliance for next 6 weeks were not collected.

Results Point of Contact

Title
Sheila K West
Organization
Johns Hopkins University
shwest@jhmi.edu
410 955 2606

Study Officials

  • Sheila K West

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2006

First Posted

July 4, 2006

Study Start

August 1, 2001

Primary Completion

December 1, 2003

Study Completion

December 1, 2006

Last Updated

August 7, 2017

Results First Posted

August 7, 2017

Record last verified: 2017-06

Locations

US(1)