Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00347776
Status:
COMPLETED
Last Update Posted:
2017-08-07
First Post:
2006-07-03
Brief Title:
Study of Azithromycin to Prevent Recurrent Trichiasis Following Surgery in Ethiopia
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Trial of Antibiotics to Reduce Recurrent Trichiasis STAR
Status:
COMPLETED
Status Verified Date:
2017-06
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:
STAR
Brief Summary:
Trachoma an ocular infection caused by C trachomatis is the second leading cause of blindness worldwideYears 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
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
The investigators 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 A randomized clinical trial of 1425 trichiasis surgical patients will be conducted in SodoEthiopia 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 patients 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 two and three years 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
The investigators 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 A randomized clinical trial of 1425 trichiasis surgical patients will be conducted in SodoEthiopia 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 patients 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 two and three years 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
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