Enhancing the A in SAFE for Trachoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

34630 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-04

Study Completion Date

2023-08-05

Brief Summary

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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.

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Detailed Description

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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

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Trachoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Routine Community-wide MDA followed by Two Additional Rounds of Treatment for Children

The 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.

Group Type EXPERIMENTAL

Azithromycin for Routine Community-wide MDA

Intervention Type DRUG

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 Children

Intervention Type DRUG

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).

Routine Community-wide MDA followed by a Second Community-wide MDA

The 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.

Group Type EXPERIMENTAL

Azithromycin for Routine Community-wide MDA

Intervention Type DRUG

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.

Azithromycin for Second Community-wide MDA

Intervention Type DRUG

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.

Standard-of-Care Annual MDA

Programmatic 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.

Group Type ACTIVE_COMPARATOR

Azithromycin for Routine Community-wide MDA

Intervention Type DRUG

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.

Interventions

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Azithromycin for Routine Community-wide MDA

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.

Intervention Type DRUG

Two Additional Rounds of Azithromycin for Children

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).

Intervention Type DRUG

Azithromycin for Second Community-wide MDA

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.

Intervention Type DRUG

Other Intervention Names

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Zithromax Zithromax Zithromax

Eligibility Criteria

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Inclusion Criteria

* 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.