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Enhancing the A in SAFE for Trachoma

NCT05634759 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 34630

Last updated 2024-02-29

No results posted yet for this study

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 of age.

Conditions

  • Trachoma

Interventions

DRUG

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.

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).

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.

Sponsors & Collaborators

  • Emory University

    lead OTHER

Principal Investigators

  • Scott Nash, PhD · The Carter Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-04
Primary Completion
2023-08-05
Completion
2023-08-05

Countries

  • South Sudan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05634759 on ClinicalTrials.gov