Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00221364
Status:
COMPLETED
Last Update Posted:
2015-07-15
First Post:
2005-09-14
Brief Title:
Trachoma Elimination Follow-up
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Trachoma Elimination With Repeated Mass Azithromycin Treatments
Status:
COMPLETED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TEF
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None