TrachomaPhase 4NCT03523156
Trachoma Elimination Study by Focused Antibiotic (TESFA)
A Phase 4 study testing Azithromycin mass treatment and Azithromycin targeted treatment in people with Trachoma, run by Emory University.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Trachoma
- What is being tested?
- Azithromycin mass treatment and Azithromycin targeted treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2025to Apr 2027
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
None listed.
Who cannot join
- none
About this study
Official title: Trachoma Elimination Study by Focused Antibiotic (TESFA): The Impact of an Enhanced Antibiotic Treatment Regimen on Trachoma in Amhara, Ethiopia
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.
Read the 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:
- 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.
- To determine the added cost and cost-effectiveness of an enhanced antibiotic treatment regimen compared to annual standard-of-care MDA.
- Conditions
- Trachoma
- Being tested
- Azithromycin mass treatment, Azithromycin targeted treatment
- Keywords
- Antibiotics, Infectious diseases, Tropical medicine, Public health
- Medical subject headings
- Trachoma, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azithromycin mass treatmentDrug
Also called Zithromax
Standard of care annual community-wide mass drug administration (MDA) will be provided at the normally scheduled time.
Azithromycin targeted treatmentDrug
Also called Zithromax
Two rounds of treatment targeted to all children aged 2 to 9 years old. The first targeted round will be 1-2 weeks after the community-wide MDA and the second round will occur another 1-2 weeks later.
| Study group | Role | What they receive |
|---|---|---|
| Azithromycin mass treatment | Active comparator | Persons living in regions randomized to this arm will receive mass drug administration (MDA) of azithromycin per the current annual MDA schedule. Receives: Drug: Azithromycin mass treatment |
| Azithromycin mass treatment plus targeted treatment | Experimental | In addition to azithromycin administration per the current annual MDA schedule, children in regions randomized to this arm will receive azithromycin targeted treatment. Receives: Drug: Azithromycin mass treatment; Drug: Azithromycin targeted treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Chlamydia trachomatis (CT) infection
The community-level prevalence of CT infection in children aged 6 months to 9 years will be compared between study arms.
Measured: Month 12
Secondary outcomes (8)
Change in prevalence of trachomatous inflammation-follicular (TF)
The prevalence of trachomatous inflammation-follicular (TF) among all household members will be noted at each visit and compared between study arms.
Measured: Baseline, Week 4, Month 12, Month 24
Change in prevalence of trachomatous inflammation-intense (TI)
The prevalence of trachomatous inflammation-intense (TI) among all household members will be noted at each visit and compared between study arms.
Measured: Baseline, Week 4, Month 12, Month 24
Change in Chlamydia trachomatis (CT) infection in children
The change in prevalence of Chlamydia trachomatis (CT) infections in children ages 6 months to 9 years will be compared between study arms. Analysis will be conducted which will include all three of these time-points to compare infection prevalence between the comparison arms
Measured: Baseline, Month 12, Month 24
Prevalence of Chlamydia trachomatis (CT) infection among adults
The prevalence of Chlamydia trachomatis (CT) infection among adults will be compared between study arms.
Measured: Month 12
Cost
The cost of the enhanced intervention will be compared to the cost of the standard-of-care intervention.
Measured: Month 24
Cost-effectiveness
The cost-effectiveness of the enhanced intervention will be compared to the cost of the standard-of-care intervention. The incremental cost effectiveness analysis ratio approach will be used. Effectiveness is defined as the percent CT reduction from baseline to 24 months and the outcome of this analysis will be the cost per percent of CT infection reduction.
Measured: Month 24
Correlation between Chlamydial Infection and trachomatous inflammation-follicular (TF) and trachomatous inflammation-intense (TI)
We will conduct cluster level analysis using cluster level Ct and clinical data including TF and TI.
Measured: Baseline, Week 4, Month 12, Month 24
Cluster-level Chlamydial load
Infectious load for all individual specimens from children aged 6 months to 9 years who test positive for CT will be measured for chlamydia load. Chlamydial load will be noted at each visit and compared between study arms.
Measured: Baseline, Week 4, Month 12, Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study startJun 2025 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionApr 2027 (estimated)
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TrachomaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Sixty-four kebeles (sub-districts) of Amhara will be randomized to receive annual mass treatment or annual mass treatment plus targeted treatment. One gott (village) per kebele will be selected and 50 children from each gott will be randomly selected.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- The Carter Center
- Responsible party
- Principal investigator, Kelly Callahan, Emory University
- Investigators
- Kelly Callahan, MPH, Principal investigator, The Carter Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03523156
- Sponsor's protocol ID
- IRB00085779
- Status last verified
- Jul 2025
- First submitted
- 1 May 2018
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trachoma Elimination Study by Focused Antibiotic (TESFA): The Impact of an Enhanced Antibiotic Treatment Regimen on Trachoma in Amhara, Ethiopia
- ClinicalTrials.gov ID
- NCT03523156
- Acronym / sponsor ID
- IRB00085779
- Conditions
- Trachoma
- Keywords
- Antibiotics, Infectious diseases, Tropical medicine, Public health
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: 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.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- The Carter Center
- Study start
- Jun 2025 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 14 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- To determine the added cost and cost-effectiveness of an enhanced antibiotic treatment regimen compared to annual standard-of-care MDA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Sixty-four kebeles (sub-districts) of Amhara will be randomized to receive annual mass treatment or annual mass treatment plus targeted treatment. One gott (village) per kebele will be selected and 50 children from each gott will be randomly selected.
| Arm | Type | Receives |
|---|---|---|
| Azithromycin mass treatment | Active comparator | Drug: Azithromycin mass treatmentPersons living in regions randomized to this arm will receive mass drug administration (MDA) of azithromycin per the current annual MDA schedule. |
| Azithromycin mass treatment plus targeted treatment | Experimental | Drug: Azithromycin mass treatment, Drug: Azithromycin targeted treatmentIn addition to azithromycin administration per the current annual MDA schedule, children in regions randomized to this arm will receive azithromycin targeted treatment. |
Who may qualify
- Ages
- 2 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azithromycin mass treatmentAlso: ZithromaxStandard of care annual community-wide mass drug administration (MDA) will be provided at the normally scheduled time. | Drug | Azithromycin mass treatment, Azithromycin mass treatment plus targeted treatment |
| Azithromycin targeted treatmentAlso: ZithromaxTwo rounds of treatment targeted to all children aged 2 to 9 years old. The first targeted round will be 1-2 weeks after the community-wide MDA and the second round will occur another 1-2 weeks later. | Drug | Azithromycin mass treatment plus targeted treatment |
Primary outcome
Prevalence of Chlamydia trachomatis (CT) infection
Time frame: Month 12
The community-level prevalence of CT infection in children aged 6 months to 9 years will be compared between study arms.
8 secondary outcomes
Change in prevalence of trachomatous inflammation-follicular (TF)
Time frame: Baseline, Week 4, Month 12, Month 24
Change in prevalence of trachomatous inflammation-intense (TI)
Time frame: Baseline, Week 4, Month 12, Month 24
Change in Chlamydia trachomatis (CT) infection in children
Time frame: Baseline, Month 12, Month 24
Prevalence of Chlamydia trachomatis (CT) infection among adults
Time frame: Month 12
Cost
Time frame: Month 24
Cost-effectiveness
Time frame: Month 24
Correlation between Chlamydial Infection and trachomatous inflammation-follicular (TF) and trachomatous inflammation-intense (TI)
Time frame: Baseline, Week 4, Month 12, Month 24
Cluster-level Chlamydial load
Time frame: Baseline, Week 4, Month 12, Month 24
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
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RESTORE: Comparing Two Approaches to Repeat TT Surgery Performed by Integrated Eye Care Workers (IECWs)
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Trachoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelly Callahan, MPH principal investigator
The Carter Center
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Azithromycin mass treatment and Azithromycin targeted treatment in people with Trachoma, run by Emory University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Chlamydia trachomatis (CT) infection (time frame: Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.