Trachoma
Conditions
Brief summary
The investigators propose a randomized controlled trial of discontinuation versus continuation of annual mass azithromycin distribution in hypoendemic communities of Maradi, Niger. 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
Programme National de Santé Oculaire (PNSO)
National Eye Institute (NEI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Months to No maximum
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. |
Countries
Niger
Contacts
PRINCIPAL_INVESTIGATORCatherine Oldenburg, ScD, MPH
University of California, San Francisco
PRINCIPAL_INVESTIGATORTom Lietman, MD
University of California, San Francisco
STUDY_DIRECTORElodie Lebas, RN
University of California, San Francisco
Participant flow
Pre-assignment details
Communities (grappes) were randomized as the unit of allocation. Monitoring surveys for outcome assessment enrolled children residing in study communities; adults were not enrolled as study participants for outcome assessment.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 1950 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 4.0 year STANDARD_DEVIATION 2.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1950 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Niger | 1981 participants |
| Sex: Female, Male Female | 958 Participants |
| Sex: Female, Male Male | 1015 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1,999 | 0 / 1,981 |
| other Total, other adverse events | 0 / 1,999 | 0 / 1,981 |
| serious Total, serious adverse events | 0 / 1,999 | 0 / 1,981 |
Outcome results
None listed