Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Trachoma Elimination Study by Focused Antibiotic (TESFA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03523156
Recruitment Status : Not yet recruiting
First Posted : May 14, 2018
Last Update Posted : January 25, 2019
Sponsor:
Collaborator:
The Carter Center
Information provided by (Responsible Party):
Kelly Callahan, Emory University

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.


Condition or disease Intervention/treatment Phase
Trachoma Drug: Azithromycin mass treatment Drug: Azithromycin targeted treatment Phase 4

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 SAFE (Surgery, Antibiotic treatment, promotion of Facial cleanliness and hygiene, and Environmental improvement) 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 6 months 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 19200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Trachoma Elimination Study by Focused Antibiotic (TESFA): The Impact of an Enhanced Antibiotic Treatment Regimen on Trachoma in Amhara, Ethiopia
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Active Comparator: Azithromycin mass treatment
Persons living in regions randomized to this arm will receive mass drug administration (MDA) of azithromycin per the current annual MDA schedule.
Drug: Azithromycin mass treatment
Standard of care annual community-wide mass drug administration (MDA) will be provided at the normally scheduled time.
Other Name: Zithromax

Experimental: Azithromycin mass treatment plus targeted treatment
In addition to azithromycin administration per the current annual MDA schedule, children in regions randomized to this arm will receive azithromycin targeted treatment.
Drug: Azithromycin mass treatment
Standard of care annual community-wide mass drug administration (MDA) will be provided at the normally scheduled time.
Other Name: Zithromax

Drug: Azithromycin targeted treatment
Two rounds of treatment targeted to all children aged 6 months 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.
Other Name: Zithromax




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in prevalence of trachomatous inflammation-follicular (TF) [ Time Frame: Baseline, Week 4, Month 12, Month 24 ]
    The prevalence of trachomatous inflammation-follicular (TF) among all household members will be noted at each visit and compared between study arms.

  2. Change in prevalence of trachomatous inflammation-intense (TI) [ Time Frame: Baseline, Week 4, Month 12, Month 24 ]
    The prevalence of trachomatous inflammation-intense (TI) among all household members will be noted at each visit and compared between study arms.

  3. Change in Chlamydia trachomatis (CT) infection in children [ Time Frame: Baseline, Month 12, Month 24 ]
    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

  4. Prevalence of Chlamydia trachomatis (CT) infection among adults [ Time Frame: Month 12 ]
    The prevalence of Chlamydia trachomatis (CT) infection among adults will be compared between study arms.

  5. Cost [ Time Frame: Month 24 ]
    The cost of the enhanced intervention will be compared to the cost of the standard-of-care intervention.

  6. Cost-effectiveness [ Time Frame: Month 24 ]
    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.

  7. Correlation between Chlamydial Infection and trachomatous inflammation-follicular (TF) and trachomatous inflammation-intense (TI) [ Time Frame: Baseline, Week 4, Month 12, Month 24 ]
    We will conduct cluster level analysis using cluster level Ct and clinical data including TF and TI.

  8. Cluster-level Chlamydial load [ Time Frame: Baseline, Week 4, Month 12, Month 24 ]
    Infectious load for all individual specimens from 6 months to 9 year-old children who test positive for CT will be measured for chlamydia load. Chlamydial load will be noted at each visit and compared between study arms.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Months to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Cluster (kebele) Inclusion Criteria:

  • The kebele must be located in Amhara and eligible for annual MDA with azithromycin under WHO treatment guidelines.
  • Located within targeted districts where the prevalence of TF is high (at least 30%) and the prevalence of CT infection is suspected to be high (10% if possible) measured from the most recent trachoma impact assessment.
  • The kebele representatives consent to participation in the trial.

Gott (village) Inclusion Criteria:

  • At least 50 children residing in the gott.

Child Inclusion Criteria:

  • Must reside in a cluster selected for this study.
  • Must have a head of household or designated "adult-in-charge" who can provide consent for that child to be included in the study sample and to consent to allowing study staff to collect an occular swab from the conjunctival epithelium.
  • Child must assent to having a swab taken.
  • Child must not have an ocular condition which would preclude grading trachoma or taking an ocular specimen.

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03523156


Contacts
Layout table for location contacts
Contact: Kelly Callahan, MPH 404-420-3833 ecallah@emory.edu

Locations
Layout table for location information
Ethiopia
Not yet recruiting
Amhara, Ethiopia
Contact: Demelash Gessesse    251 920 258 272      
Contact: Zerihun Tadesse    251-91-140-1498    Zerihun.Tadesse@cartercenter.org   
Sponsors and Collaborators
Emory University
The Carter Center
Investigators
Layout table for investigator information
Principal Investigator: Kelly Callahan, MPH The Carter Center

Layout table for additonal information
Responsible Party: Kelly Callahan, Program Director, Emory University
ClinicalTrials.gov Identifier: NCT03523156     History of Changes
Other Study ID Numbers: IRB00085779
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Kelly Callahan, Emory University:
Antibiotics
Infectious diseases
Tropical medicine
Public health
Additional relevant MeSH terms:
Layout table for MeSH terms
Trachoma
Conjunctivitis, Bacterial
Eye Infections, Bacterial
Bacterial Infections
Chlamydia Infections
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Eye Infections
Infection
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Anti-Bacterial Agents
Azithromycin
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents