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Trachoma Elimination Follow-up (TEF)

Primary Purpose

Trachoma, Chlamydia

Status
Completed
Phase
Phase 4
Locations
Ethiopia
Study Type
Interventional
Intervention
Mass treatment with oral azithromycin to an entire village
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trachoma focused on measuring Trachoma, Chlamydia, Azithromycin

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 1 to 5 years old in a village in the Gurage zone with endemic trachoma Exclusion Criteria: Refusal of village chief (for village inclusion), or refusal of parent or guardian (for individual inclusion)

Sites / Locations

  • ORBIS-Ethiopia

Outcomes

Primary Outcome Measures

The prevalence of ocular chlamydia infection in a village as determined by PCR

Secondary Outcome Measures

Clinical active trachoma, as determined by the WHO simplified grading system, by village

Full Information

First Posted
September 14, 2005
Last Updated
July 13, 2015
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT00221364
Brief Title
Trachoma Elimination Follow-up
Acronym
TEF
Official Title
Trachoma Elimination With Repeated Mass Azithromycin Treatments
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
April 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The WHO has initiated a program to eliminate blinding trachoma by the year 2020, in large part by mass oral azithromycin distributions. It is not clear how frequently or for how long these treatments are necessary. Here we assess the frequency and duration of treatment.
Detailed Description
40 villages in the Gurage Zone of Ethiopia were randomly assigned to biannual treatment, annual treatment, and a single treatment. Each treatment consisted of a single dose of oral azithromycin to the entire population over the age of 1 year (when the study was started, azithromycin had not yet been approved for ages below 1 year). We assess the prevalence the ocular chlamydia that causes trachoma in the peak prevalence age of 1-5 years at baseline, and 2, 6, 12, 18, and 24 months post treatment. An extension of the study monitors infection at 30 and 36 months post treatment. Untreated villages from the same area are enrolled in a step-wedge design to assess the presence of a secular trend. A random sample of those not within the 1-5 year old age group are examined to assess the prevalence of infection in the entire community.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trachoma, Chlamydia
Keywords
Trachoma, Chlamydia, Azithromycin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
20000 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Mass treatment with oral azithromycin to an entire village
Primary Outcome Measure Information:
Title
The prevalence of ocular chlamydia infection in a village as determined by PCR
Secondary Outcome Measure Information:
Title
Clinical active trachoma, as determined by the WHO simplified grading system, by village

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 1 to 5 years old in a village in the Gurage zone with endemic trachoma Exclusion Criteria: Refusal of village chief (for village inclusion), or refusal of parent or guardian (for individual inclusion)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas M Lietman, MD
Organizational Affiliation
Proctor Foundation, UCSF
Official's Role
Principal Investigator
Facility Information:
Facility Name
ORBIS-Ethiopia
City
Addis Ababa
Country
Ethiopia

12. IPD Sharing Statement

Citations:
PubMed Identifier
15304470
Citation
Melese M, Chidambaram JD, Alemayehu W, Lee DC, Yi EH, Cevallos V, Zhou Z, Donnellan C, Saidel M, Whitcher JP, Gaynor BD, Lietman TM. Feasibility of eliminating ocular Chlamydia trachomatis with repeat mass antibiotic treatments. JAMA. 2004 Aug 11;292(6):721-5. doi: 10.1001/jama.292.6.721.
Results Reference
background
PubMed Identifier
15494901
Citation
Chidambaram JD, Melese M, Alemayehu W, Yi E, Prabriputaloong T, Lee DC, Cevallos V, Zhou Z, Whitcher JP, Gaynor BD, Lietman TM. Mass antibiotic treatment and community protection in trachoma control programs. Clin Infect Dis. 2004 Nov 1;39(9):e95-7. doi: 10.1086/424747. Epub 2004 Oct 6.
Results Reference
background
PubMed Identifier
17683646
Citation
Ray KJ, Porco TC, Hong KC, Lee DC, Alemayehu W, Melese M, Lakew T, Yi E, House J, Chidambaram JD, Whitcher JP, Gaynor BD, Lietman TM. A rationale for continuing mass antibiotic distributions for trachoma. BMC Infect Dis. 2007 Aug 7;7:91. doi: 10.1186/1471-2334-7-91.
Results Reference
background
PubMed Identifier
17255240
Citation
Lee S, Alemayehu W, Melese M, Lakew T, Lee D, Yi E, Cevallos V, Donnellan C, Zhou Z, Chidambaram JD, Gaynor BD, Whitcher JP, Lietman TM. Chlamydia on children and flies after mass antibiotic treatment for trachoma. Am J Trop Med Hyg. 2007 Jan;76(1):129-31.
Results Reference
background
PubMed Identifier
16522834
Citation
Chidambaram JD, Alemayehu W, Melese M, Lakew T, Yi E, House J, Cevallos V, Zhou Z, Maxey K, Lee DC, Shapiro BL, Srinivasan M, Porco T, Whitcher JP, Gaynor BD, Lietman TM. Effect of a single mass antibiotic distribution on the prevalence of infectious trachoma. JAMA. 2006 Mar 8;295(10):1142-6. doi: 10.1001/jama.295.10.1142.
Results Reference
background
PubMed Identifier
20649409
Citation
Haug S, Lakew T, Habtemariam G, Alemayehu W, Cevallos V, Zhou Z, House J, Ray K, Porco T, Rutar T, Keenan J, Lietman TM, Gaynor BD. The decline of pneumococcal resistance after cessation of mass antibiotic distributions for trachoma. Clin Infect Dis. 2010 Sep 1;51(5):571-4. doi: 10.1086/655697.
Results Reference
background
PubMed Identifier
20302432
Citation
Shah NA, House J, Lakew T, Alemayehu W, Halfpenny C, Hong KC, Keenan JD, Porco TC, Whitcher JP, Lietman TM, Gaynor BD. Travel and implications for the elimination of trachoma in ethiopia. Ophthalmic Epidemiol. 2010 Mar;17(2):113-7. doi: 10.3109/09286581003624921.
Results Reference
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PubMed Identifier
20207878
Citation
Keenan JD, Lakew T, Alemayehu W, Melese M, Porco TC, Yi E, House JI, Zhou Z, Ray KJ, Acharya NR, Whitcher JP, Gaynor BD, Lietman TM. Clinical activity and polymerase chain reaction evidence of chlamydial infection after repeated mass antibiotic treatments for trachoma. Am J Trop Med Hyg. 2010 Mar;82(3):482-7. doi: 10.4269/ajtmh.2010.09-0315.
Results Reference
background
PubMed Identifier
19744717
Citation
Biebesheimer JB, House J, Hong KC, Lakew T, Alemayehu W, Zhou Z, Moncada J, Roger A, Keenan J, Gaynor BD, Schachter J, Lietman TM. Complete local elimination of infectious trachoma from severely affected communities after six biannual mass azithromycin distributions. Ophthalmology. 2009 Nov;116(11):2047-50. doi: 10.1016/j.ophtha.2009.04.041. Epub 2009 Sep 10.
Results Reference
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PubMed Identifier
19707573
Citation
Lakew T, Alemayehu W, Melese M, Yi E, House JI, Hong KC, Zhou Z, Ray KJ, Porco TC, Gaynor BD, Lietman TM, Keenan JD. Importance of coverage and endemicity on the return of infectious trachoma after a single mass antibiotic distribution. PLoS Negl Trop Dis. 2009 Aug 25;3(8):e507. doi: 10.1371/journal.pntd.0000507.
Results Reference
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PubMed Identifier
19190781
Citation
Lakew T, House J, Hong KC, Yi E, Alemayehu W, Melese M, Zhou Z, Ray K, Chin S, Romero E, Keenan J, Whitcher JP, Gaynor BD, Lietman TM. Reduction and return of infectious trachoma in severely affected communities in Ethiopia. PLoS Negl Trop Dis. 2009;3(2):e376. doi: 10.1371/journal.pntd.0000376. Epub 2009 Feb 3.
Results Reference
background
PubMed Identifier
19624926
Citation
Hong KC, Schachter J, Moncada J, Zhou Z, House J, Lietman TM. Lack of macrolide resistance in Chlamydia trachomatis after mass azithromycin distributions for trachoma. Emerg Infect Dis. 2009 Jul;15(7):1088-90. doi: 10.3201/eid1507.081563.
Results Reference
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PubMed Identifier
18689701
Citation
Yang JL, Hong KC, Schachter J, Moncada J, Lekew T, House JI, Zhou Z, Neuwelt MD, Rutar T, Halfpenny C, Shah N, Whitcher JP, Lietman TM. Detection of Chlamydia trachomatis ocular infection in trachoma-endemic communities by rRNA amplification. Invest Ophthalmol Vis Sci. 2009 Jan;50(1):90-4. doi: 10.1167/iovs.08-2247. Epub 2008 Aug 8.
Results Reference
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PubMed Identifier
18285589
Citation
Melese M, Alemayehu W, Lakew T, Yi E, House J, Chidambaram JD, Zhou Z, Cevallos V, Ray K, Hong KC, Porco TC, Phan I, Zaidi A, Gaynor BD, Whitcher JP, Lietman TM. Comparison of annual and biannual mass antibiotic administration for elimination of infectious trachoma. JAMA. 2008 Feb 20;299(7):778-84. doi: 10.1001/jama.299.7.778.
Results Reference
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PubMed Identifier
18194094
Citation
Gill DA, Lakew T, Alemayehu W, Melese M, Zhou Z, House JI, Hong KC, Ray KJ, Gandhi N, Whitcher JP, Gaynor BD, Lietman TM. Complete elimination is a difficult goal for trachoma programs in severely affected communities. Clin Infect Dis. 2008 Feb 15;46(4):564-6. doi: 10.1086/526777.
Results Reference
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PubMed Identifier
21482879
Citation
Keenan JD, Lakew T, Alemayehu W, Melese M, House JI, Acharya NR, Porco TC, Gaynor BD, Lietman TM. Slow resolution of clinically active trachoma following successful mass antibiotic treatments. Arch Ophthalmol. 2011 Apr;129(4):512-3. doi: 10.1001/archophthalmol.2011.46. No abstract available.
Results Reference
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PubMed Identifier
22736616
Citation
Cevallos V, Whitcher JP, Melese M, Alemayehu W, Yi E, Chidambaram JD, Lee S, Reddy H, Gaynor BD, Lietman TM, Keenan JD. Association of conjunctival bacterial infection and female sex in cicatricial trachoma. Invest Ophthalmol Vis Sci. 2012 Aug 7;53(9):5208-12. doi: 10.1167/iovs.12-9984.
Results Reference
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PubMed Identifier
21685340
Citation
See CW, Alemayehu W, Melese M, Zhou Z, Porco TC, Shiboski S, Gaynor BD, Eng J, Keenan JD, Lietman TM. How reliable are tests for trachoma?--a latent class approach. Invest Ophthalmol Vis Sci. 2011 Aug 3;52(9):6133-7. doi: 10.1167/iovs.11-7419.
Results Reference
derived

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Trachoma Elimination Follow-up

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