Chlamydia, Trachoma
Conditions
Keywords
Bacterial Infections, Chlamydia Infections, Eye Diseases
Brief summary
The WHO has initiated a program to eliminate trachoma, blinding eye infection caused by Chlamydia trachomatis, in large part by mass distributions of oral azithromycin. The proposed study will determine the frequency and treatment target of community-wide mass antibiotic treatment. We will also study the impact of mass antibiotic distribution on antibiotic-resistance in pneumococcus.
Detailed description
The proposed study is a group-randomized trial to determine the frequency and treatment target of community-wide mass antibiotic treatment to eliminate trachoma. We will also study the impact of community-wide antibiotic distribution on antibiotic-resistance in pneumococcus. Communities in Goncha Siso Enese district of East Gojam Zone, Ethiopia will be randomly assigned to different treatment schemes and monitored to study the following research questions: Specific Aim 1. To determine whether biannual mass treatments is more likely to eliminate ocular chlamydia from hyper-endemic communities than annual mass treatments. Specific Aim 2. To determine whether children form a core group for the transmission of trachoma. Specific Aim 3. To determine whether latrine construction prevents the return of infection into a community after mass treatment. Specific Aim 4. To determine the effect of mass azithromycin treatments on antibiotic resistance in pneumococcus and the reduction in mortality. Specific Aim 5. To determine whether annual mass treatments are more likely to eliminate ocular chlamydia from hyper-endemic communities than biennial mass treatments.
Interventions
DRUGMass treatment with oral azithromycin to an entire community
For baseline and follow-up surveys prior to azithromycin distribution, a stratified random sample from two age groups will be chosen: 1) 60 study participants younger than 10 years old and 2) 60 study participants aged 10 years and above. Clinical examination will be performed and conjunctival swabs will be taken from all the study participants. For study arm C and D, nasopharyngeal swabs will be collected from 10 randomly selected children among the 60 participants under 10 who were recruited for conjunctival swabbing. Then a single dose of azithromycin will be distributed according to study design: in tablet form for adults; a weight-adjusted tablet dose for children ages 8-10; and pediatric suspension for children ages 1 - 7.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
• All residents residing in the state-teams which are randomly selected for this study.
Exclusion criteria
* Pregnant women * Children under 6 months of age * All those who are allergic to macrolides or azalides * Refusal of village chief (for village inclusion), or refusal of parent or guardian (for individual inclusion) Individuals in these three
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The average prevalence of ocular chlamydia infection in communities in an arm as determined by pooled NAAT (Nucleic Acid Amplification Test)(at 42 months for Aim 1, at 12 months for Aim 2, post-treatment relative to pre-treatment for Aim 3) | 42 months |
Secondary
| Measure | Time frame |
|---|---|
| Clinical active trachoma in community, as determined by the WHO simplified grading system | 42 months |
| Childhood (>= 1 year of age) mortality, analyzed as 1-5, 6-10 years of age, and total | 42 months |
| Macrolide resistance in pneumococcus (% resistance over time, clustered by randomization unit) | 42 months |
| Average prevalence of ocular chlamydia infection in annually and biennially treated communities as determined by pooled NAAT (Nucleic Acid Amplification Test) | 48 months |
| Diversity measure in the conjunctival and nasopharyngeal microbiomes of children (age 0-9) | 0, 6, 12, 18, 24, 30, 36, 42, and 48 months |
Countries
Ethiopia
Outcome results
None listed