Clinical trial NCT00221364: Trachoma Elimination Follow-up
Official title: Trachoma Elimination With Repeated Mass Azithromycin Treatments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Trachoma
Chlamydia
Keywords: Trachoma
Chlamydia
Azithromycin
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 20000
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: The prevalence of ocular chlamydia infection in a village as determined by PCR
Secondary outcomes:
measure: Clinical active trachoma, as determined by the WHO simplified grading system, by village
Other outcomes:
Locations:
city: Addis Ababa
country: Ethiopia
facility: ORBIS-Ethiopia
Study officials:
affiliation: Proctor Foundation, UCSF
name: Thomas M Lietman, MD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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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.
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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.
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