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TrachomaPhase 4NCT05634759

Enhancing the A in SAFE for Trachoma

A Phase 4 study testing Azithromycin for Routine Community-wide MDA, Two Additional Rounds of Azithromycin for Children and Azithromycin for Second Community-wide MDA in people with Trachoma, run by Emory University at 1 site in South Sudan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will assess the cost and feasibility of two strategies of enhanced Mass Drug Administration (MDA) of Zithromax to treat trachoma in the Republic of South Sudan. The secondary objectives of this study are to measure trachoma infection outcomes during the 12-month follow-up period among children up to 9 years… Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Trachoma
What is being tested?
Azithromycin for Routine Community-wide MDA, Two Additional Rounds of Azithromycin for Children and Azithromycin for Second Community-wide MDA
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34,630 participants
Where
1 siteSouth Sudan
Study dates
4 May 2022to 5 Aug 2023
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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • The village must be located in a district eligible for annual MDA with azithromycin under WHO treatment guidelines.
  • The village representatives' consent to participation in the study. Individual consent will also be obtained for each individual within the study.
  • Children aged 6 months to 9 years of age
  • Consent for child inclusion is obtained by the parent/guardian and adequate provisions are made to solicit assent from the child.

Who cannot join

  • none

Trial locations and contacts

1 site in 1 country.

South Sudan1 site
  • Ministry of Health Republic of South Sudan

    Juba

About this study

Official title: Enhancing the A in SAFE: Accelerating Trachoma Elimination in the Republic of South Sudan

This study will assess the cost and feasibility of two strategies of enhanced Mass Drug Administration (MDA) of Zithromax to treat trachoma in the Republic of South Sudan. The secondary objectives of this study are to measure trachoma infection outcomes during the 12-month follow-up period among children up to 9 years of age.

Read the detailed description

Trachoma is an ocular disease caused by the bacterium Chlamydia trachomatis. The World Health Organization (WHO) has recently targeted trachoma for global elimination as a public health problem by 2030. Though progress has been made in reducing the burden of trachoma in many endemic countries, those affected by conflict and humanitarian emergencies have been left behind and will likely take decades to reach trachoma elimination targets. To "catch-up", these countries must consider enhancements to the surgery, antibiotic, facial cleanliness, and environmental improvement (SAFE) strategy.

Evidence for the importance of enhanced mass drug administration (MDA) strategies is growing, particularly with the help of modeling studies. Recent work by the neglected tropical disease (NTD) modeling consortium has recently demonstrated that in some hyperendemic districts, annual MDA will not result in a district reaching the elimination as a public health problem threshold within 10 years. Delays in implementation whether due to insecurity or to coronavirus disease 2019 (COVID-19) would likely lead to higher prevalence trachoma prevalence in these districts for years to come. However, when testing alternative MDA strategies, modelers found that the annual trajectory of trachoma prevalence could be changed. One MDA alternative characterized by a community-wide MDA followed by two extra rounds of treatment to children aged 2 to 9 years 1 week and again 3 weeks after the normal community wide MDA, demonstrated a considerable faster time to elimination compared to standard of care. Empirical data from the field under different alternative MDA strategies are needed to verify these modeling results.

The Republic of South Sudan has historically had one of the highest burdens of trachoma in the world. Currently the county has many districts considered highly endemic, and therefore reaching the elimination of trachoma as a public health problem by the year 2030 will likely be a large challenge. Based on 2015 trachoma prevalence data, trachomatous inflammation-follicular among children ages 1 to 9 years ranged from 30% to 48% across three Kapoeta counties in Eastern Equatoria state, Republic of South Sudan and trachomatous trichiasis ranged from 2.6% to 3.7% in those ages 15 years and above, both indicators above WHO elimination thresholds. The Republic of South Sudan Ministry of Health, with support from The Carter Center, has been implementing the SAFE strategy in these three counties (Kapoeta North, Kapoeta South, and Kapoeta East) for over 10 years. Interventions have included the provision of surgery, conducting MDA, and providing health education. All three counties conducted their fifth consecutive annual round of MDA between October 2020 to December 2020 and will therefore be scheduled to conduct an impact survey in 2021.

Thirty villages in the Republic of South Sudan will be randomized to participate in one of two enhanced MDA strategies. Enhanced MDA strategy 1 consists of a routine community-wide MDA followed by two additional rounds targeted to children age 6 months to 9 years. The additional rounds of treatment will occur 2 weeks apart and will begin 1 week after the community-wide MDA. Enhanced MDA Strategy 2 consist of a routine community-wide MDA followed by a second community-wide MDA approximately 6-8 months later. Participants will be followed for 12 months.

Conditions
Trachoma
Being tested
Azithromycin for Routine Community-wide MDA, Two Additional Rounds of Azithromycin for Children, Azithromycin for Second Community-wide MDA
Keywords
Mass drug administration, South Sudan, Trachoma
Medical subject headings
Trachoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Azithromycin for Routine Community-wide MDADrug

    Also called Zithromax

    Oral azithromycin, also known as the brand name Zithromax®, is a macrolide antibiotic and is used in the treatment of active trachoma. The recommended dosage for the treatment of trachoma is a single dose of 20mg/kg of body weight and is implemented by a "Age-height" based dosing strategy for the trachoma MDA campaigns. Oral azithromycin can be administrated in either tablet form or powder for oral suspension (POS). Zithromax® is donated by Pfizer Inc through the International Trachoma Initiative (ITI) to the South Sudan Federal Ministry of Health to use in community-wide MDA throughout South Sudan.

  • Two Additional Rounds of Azithromycin for ChildrenDrug

    Also called Zithromax

    An additional round of treatment will be given one week after the routine community-wide MDA, and a second additional round will be given two weeks later (3 weeks after the routine community-wide MDA).

  • Azithromycin for Second Community-wide MDADrug

    Also called Zithromax

    A second community-wide MDA will be given 6 to 8 months after the routine community-wide MDA. The timing of the second MDA will depend on local conditions and logistical concerns.

Study groups in NCT05634759
Study groupRoleWhat they receive
Routine Community-wide MDA followed by Two Additional Rounds of Treatment for ChildrenExperimentalThe enhanced MDA Strategy 1 consists of a routine community-wide MDA followed by two additional rounds targeted to children age 6 months to 9 years. The additional rounds of treatment will occur 2 weeks apart and will begin 1 week after the community-wide MDA.
Receives: Drug: Azithromycin for Routine Community-wide MDA; Drug: Two Additional Rounds of Azithromycin for Children
Routine Community-wide MDA followed by a Second Community-wide MDAExperimentalThe enhanced MDA Strategy 2 consist of a routine community-wide MDA followed by a second community-wide MDA approximately 6-8 months later. The timing of the second MDA will depend on local conditions and logistical concerns.
Receives: Drug: Azithromycin for Routine Community-wide MDA; Drug: Azithromycin for Second Community-wide MDA
Standard-of-Care Annual MDAActive comparatorProgrammatic Control Comparator data for the standard-of-care annual MDA will come from the MDA conducted in 2022 in a random selection of 15 non-study villages.
Receives: Drug: Azithromycin for Routine Community-wide MDA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Coverage Among Young Children

    Feasibility of enhanced antibiotic regimens will be assessed as antibiotic coverage during each of the subsequent treatment rounds, allowing for the calculation of the number of doses each participant received. The definition of coverage for this study is the number of individuals ages 6 months to 9 years who received the drug in study villages in each treatment round divided by number of children ages 6 months to 9 years enumerated in the baseline census. MDA coverage will be further validated through use of the WHO's Supervision Coverage Tool.

    Measured: Up to 12 months

  2. Number of Participants Missing Antibiotic Treatment Round

    Compliance with the enhanced antibiotic regimens will be assessed as the extent of missed rounds of antibiotic treatment.

    Measured: Up to 12 months

  3. Acceptability

    The acceptability of enhanced antibiotic regimens will be assessed through focus group discussions which are led by a trained qualitative researcher using a guided discussion tool. Discussion topics include perceptions of trachoma disease and treatment, perception of the MDA campaigns, and community mobilization. This qualitative assessment will not generate a summary score.

    Measured: Up to 12 months

  4. Cost

    The cost of enhanced antibiotic regimens will be compared to each other and compared to the standard-of-care, annual MDA. The researchers will examine both financial costs (expenditures from the implementation of the intervention), and economic costs (full value of the resources used to implement the intervention). Cost data will be categorized under the following categories: capital costs, medical personnel costs, non-medical personnel costs, commodities, field consumable costs, and lab costs as informed by previous studies.

    Measured: Up to 12 months

Secondary outcomes (4)
  1. Prevalence of C. trachomatis Infection

    Children age 6 months to 9 years selected for the study will receive ocular swabbing for C. trachomatis infection. The conjunctival epithelial specimen will be used for polymerase chain reaction (PCR) analysis in the lab.

    Measured: Up to 12 months

  2. Prevalence of Clinical Trachoma by Field Grader

    A field grader will assess both eyes of each child age 6 months to 9 years selected for the study. The grader will note their assessment of trachoma grade prior the ocular swab being obtained.

    Measured: Up to 12 months

  3. Prevalence of Clinical Trachoma by Photograph

    Tarsal conjunctivae photographs will be taken of both eyes of each child age 6 months to 9 years selected to provide an ocular swab for the study. Images will be sent to a grading center located off-site to be graded by a designated standard grader.

    Measured: Up to 12 months

  4. Coverage Among Older Children and Adults

    Feasibility of enhanced antibiotic regimens will be assessed as antibiotic coverage during each of the subsequent treatment rounds, allowing for the calculation of the number of doses each participant received. The definition of coverage for this secondary analysis is the number of individuals aged 10 to 15 years, and the number of persons greater than 15 years old who received the drug in study villages in each treatment round divided by number of individuals in each age group enumerated in the baseline census.

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2022
  2. Study start4 May 2022
  3. Primary completion5 Aug 2023
  4. Study completion5 Aug 2023

Resources

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
Thirty villages will be randomized to one of two intervention arms (15 villages per study arm). To conduct the cost comparison, comparator data for the standard-of-care annual MDA will be obtained from the MDA conducted in 2022 in a random selection of 15 non-study villages.
Masking
None (open label)
Enrolment
34,630 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05634759
Sponsor's protocol ID
STUDY00002467
Status last verified
Feb 2024
First submitted
22 Nov 2022
Last updated
29 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sanders AM, Makoy S, Deathe AR, Ohidor S, Jesudason TC, Nute AW, Odongi P, Boniface L, Abuba S, Delahaut AS, Sebit W, Niquette J, Callahan EK, Walker DG, Nash SD. Cost and community acceptability of enhanced antibiotic distribution approaches for trachoma in the Republic of South Sudan: enhancing the A in SAFE (ETAS) study protocol. BMC Ophthalmol. 2023 Feb 6;23(1):51. doi: 10.1186/s12886-023-02783-x.

    PubMed 36747194

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Azithromycin for Routine Community-wide MDA, Two Additional Rounds of Azithromycin for Children and Azithromycin for Second Community-wide MDA in people with Trachoma, run by Emory University at 1 site in South Sudan.

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 4 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: finished, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Sudan. Whether a site is taking part right now should be confirmed with that site. See every site.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Coverage Among Young Children (time frame: Up to 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05634759, which also lists 1 linked publication.

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 29 Feb 2024.

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