Trachoma
Conditions
Brief summary
The investigators propose a randomized controlled trial of discontinuation versus continuation of annual mass azithromycin distribution in hypoendemic communities of Maniema, DRC. The investigators will randomize communities with up to 20% Trachomatous Inflammation - Follicular (TF) prevalence following at least 5 years of mass azithromycin distribution to discontinuation or continuation of 3 additional years of annual mass azithromycin distribution.
Interventions
DRUGAzithromycin
In study communities randomized to the Azithromycin Continuation arm, all individuals aged 1 month and older will receive a single mass distribution of azithromycin several weeks after the baseline and 36-month monitoring visits. In study communities randomized to Azithromycin Discontinuation, participants will receive no treatment.
Sponsors
University of California, San Francisco
Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
National Eye Institute (NEI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Double (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Months to 9 Years
Healthy volunteers
Yes
Inclusion criteria
* Provision of appropriate informed consent * Stated willingness to comply with all study procedures * Live in one of the 80 communities with up to 20% prevalence of TF selected for the trial
Exclusion criteria
* Does not consent to participation * Unwilling to comply with all study procedures * Does not live in one of the 80 communities with up to 20% prevalence of TF selected for the trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular chlamydia measured in a population-based sample of 0-9 year-old children | 36 months | Assessed by PCR. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infectious load of chlamydia among 0-9-year-old children infected with ocular chlamydia | 36 months | Assessed by PCR. |
| Conjunctival inflammation | 36 months | Assessed from conjunctival photography. Clinical photographs of the conjunctiva will be assessed by masked graders according to the grading scale described by the WHO Simplified Grading System. The system includes five signs, each of which can be present or absent: Trachomatous inflammation - follicular Trachomatous inflammation-intense Trachomatous scarring Trachomatous trichiasis Corneal opacity |
Countries
Democratic Republic of the Congo
Contacts
PRINCIPAL_INVESTIGATORCatherine Oldenburg, ScD, MPH
University of California, San Francisco
PRINCIPAL_INVESTIGATORThomas Lietman, MD
University of California, San Francisco
STUDY_DIRECTORElodie Lebas, RN
University of California, San Francisco
Outcome results
None listed