Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-25 @ 9:15 PM
Study NCT ID:
NCT03523156
Status:
WITHDRAWN
Last Update Posted:
2025-07-16
First Post:
2018-05-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trachoma Elimination Study by Focused Antibiotic (TESFA)
Sponsor:
Emory University
Organization:
Study Overview
Official Title:
Trachoma Elimination Study by Focused Antibiotic (TESFA): The Impact of an Enhanced Antibiotic Treatment Regimen on Trachoma in Amhara, Ethiopia
Status:
WITHDRAWN
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The Trachoma Elimination Study by Focused Antibiotic (TESFA): The Impact of an Enhanced Antibiotic Treatment Regimen on Trachoma in Amhara, Ethiopia is withdrawn due to severe delays and continued insecurity in the Amhara region of Ethiopia.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study population consists of all households residing in eligible kebeles (sub-districts) within districts in Amhara National Regional State which are identified as having a high prevalence of trachoma and infection measured from recent trachoma impact assessments. Within each study kebele, one village will be randomly selected to serve as the sentinel study site for that kebele. Once these villages are chosen, the study team will use government-provided census records, or perform a census in each village, and will randomly choose 50 children to serve as the sentinel children for the study. After the baseline visit, all kebeles will be randomized into one of the two treatment arms to either receive standard-or-care treatment, which is an annual community-wide mass drug administration (MDA), or the enhanced antibiotic treatment. Recruitment will take place at the selected children's household. Oral informed consent will be sought from village leader/chairmen before surveys are conducted in a village. Oral informed consent will then be obtained from household heads of those houses included in the study; and then from each participating individual. Oral consents will be obtained given the low literacy rates in rural Amhara.
Data collection will occur at baseline, week 4, month 12, and month 24 in both arms of the study. A head of household will be asked a series of household level questions, which will be followed by a household-level census, where all consenting participants residing in the selected households will have their eyes examined for trachoma signs. This is a non-invasive procedure whereby a trained trachoma grader flips each eyelid and examines for trachoma signs. Lastly, the selected child and one randomly selected adult will have their right eye lid swabbed for evidence of trachoma infection. The total estimated respondent burden is 30 to 45 minutes.
Data collection will occur at baseline, week 4, month 12, and month 24 in both arms of the study. A head of household will be asked a series of household level questions, which will be followed by a household-level census, where all consenting participants residing in the selected households will have their eyes examined for trachoma signs. This is a non-invasive procedure whereby a trained trachoma grader flips each eyelid and examines for trachoma signs. Lastly, the selected child and one randomly selected adult will have their right eye lid swabbed for evidence of trachoma infection. The total estimated respondent burden is 30 to 45 minutes.
Detailed Description:
Trachoma, caused by ocular infection with Chlamydia trachomatis, is one of the leading causes of preventable blindness worldwide with 51 countries known or suspected to be endemic for blinding trachoma. The World Health Organization (WHO) has recommended the Surgery, Antibiotic treatment, promotion of Facial cleanliness and hygiene, and Environmental improvement (SAFE) strategy for trachoma control. Annual mass drug administration (MDA) with the antibiotic azithromycin to treat trachoma is effective, at least in areas with moderate to low levels or trachoma. This has not been the experience in regions with high levels of trachoma including Amhara, Ethiopia. After 8 rounds of annual MDA, trachoma remains stubbornly high throughout the region. Given this experience from the Amhara region of Ethiopia, The Carter Center will work with local government partners at the regional, zonal, district, and sub-district levels to assess the effectiveness of a targeted antibiotic treatment regimen on trachoma prevalence by using a cluster randomized, controlled trial design with the understanding that increasing the need for drug in the short-term to intensify impact, may result in reduced need for drug in the long-term. The effectiveness of this alternative treatment regimen will be assessed over a period of 2 years by periodically evaluating trachoma outcomes throughout study communities.
The key objectives of this study are to:
1. To determine the effectiveness of an enhanced antibiotic treatment regimen characterized by a community-wide MDA followed by two rounds of targeted (to children age 2 to 9 years) treatment in quick succession (1-2 weeks apart) compared to annual standard-of-care MDA.
2. To determine the added cost and cost-effectiveness of an enhanced antibiotic treatment regimen compared to annual standard-of-care MDA.
The key objectives of this study are to:
1. To determine the effectiveness of an enhanced antibiotic treatment regimen characterized by a community-wide MDA followed by two rounds of targeted (to children age 2 to 9 years) treatment in quick succession (1-2 weeks apart) compared to annual standard-of-care MDA.
2. To determine the added cost and cost-effectiveness of an enhanced antibiotic treatment regimen compared to annual standard-of-care MDA.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: