Chlamydia Clinical Trial
Official title:
Tripartite International Research for the Elimination of Trachoma
Mass antimicrobial administrations have been remarkably successful in reducing the prevalence
of the ocular strains of Chlamydia that cause trachoma. Repeated distributions progressively
lower the prevalence of infection, and in some cases may even result in local elimination.
Mass treatments cannot be continued forever, due to concerns about cost and antibiotic
resistance. The hope has been that other measures such as latrine construction and hygiene
programs would prevent infection from returning. Unfortunately, no non-antibiotic measure has
yet demonstrated an effect on infection.
1. We hypothesize that Chlamydial infection will return to communities when treatment ends.
2. We hypothesize that infection will be completely eliminated in all communities treated
for seven years.
3. We hypothesize that identifying and treating clinically active cases among preschool
aged children will delay or even prevent reemergence at a far lower cost than mass
treatment of all individuals.
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 continue to
monitor a sub-set of communities from our TANA study, in Goncha Siso Enese district of East
Gojam Zone, Ethiopia. Here we evaluate how infection returns when antibiotics are
discontinued, whether infection can be predictably eliminated, and whether infection can be
prevented from returning with targeted treatment strategies:
Specific Aim 1. To determine whether antibiotics can be stopped after 4 years.
Specific Aim 2. To determine whether infection can be completely eliminated if mass
treatments continue for seven years.
Specific Aim 3. To determine whether treatment targeted to pre-school aged children, or to
households in which a pre-school aged child has clinically active trachoma, will prevent
infection from returning into the community.
Specific Aim 4: To determine whether mass azithromycin distributions reduce visits to local
health clinics due to all causes and infectious causes.
Specific Aim 5: To determine whether mass azithromycin distributions result in better growth
metrics (weight-for-height, height-for age, weight-for-age, middle upper arm circumference)
compared to no treatment.
Specific Aim 6: To determine whether under-5 mortality is lower in communities treated with
mass azithromycin compared to no treatment
Specific Aim 7: To determine whether macrolide resistance in Streptococcus pneumoniae,
Hameophilus influenzae, and Staphylococcus aureus is more prevalent in communities treated
with biannual mass azithromycin compared to communities treated with annual mass
azithromycin, and to determine whether targeted azithromycin treatments result in less
macrolide resistance compared to mass azithromycin distributions.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02493647 -
Love, Sex & Choices: A Web Series on Mobile Devices to Reduce Black Women's HIV Risk
|
N/A | |
Completed |
NCT01439503 -
Safer Sex Program for Young African-American Men
|
Phase 2 | |
Completed |
NCT01140022 -
Leveraging Technology as a Clinician Extender to Screen Culturally Diverse Young Women for Chlamydia
|
N/A | |
Not yet recruiting |
NCT06428643 -
A Seek, Test, and Treat Intervention to Reduce Chlamydia Trachomatis Disparities
|
N/A | |
Completed |
NCT03896776 -
A Pragmatic Trial of Two Strategies for Implementing an Effective eHealth HIV Prevention Program (Keep It Up! 3.0)
|
N/A | |
Completed |
NCT00187902 -
Evaluation of NAATs for Detection of C. Trachomatis and N. Gonorrhoeae From Pharynx, Rectum, Glans & Urethra of MSM
|
N/A | |
Completed |
NCT04553068 -
Evaluation of EVO100 for Prevention of Urogenital Chlamydia Trachomatis and Neisseria Gonorrhoeae Infection
|
Phase 3 | |
Active, not recruiting |
NCT03980223 -
Evaluation of Doxycycline Post-exposure Prophylaxis to Reduce Sexually Transmitted Infections in PrEP Users and HIV-infected Men Who Have Sex With Men
|
Phase 4 | |
Completed |
NCT01465607 -
Implementation of an Efficacious Intervention for High Risk Women in Mexico
|
N/A | |
Completed |
NCT01596946 -
Home-sampling in Partner Notification of Chlamydia
|
N/A | |
Completed |
NCT01836445 -
Keep It Up! 2.0: A Comparison of Two Online HIV Intervention Programs for Young Men Who Have Sex With Men
|
N/A | |
Completed |
NCT02122094 -
Implementation of a Sexual Health Intervention for Young Men Who Have Sex With Men (MSM) in Two Vietnamese Cities
|
N/A | |
Completed |
NCT00827697 -
A Validation Study for Detecting Chlamydia and Gonorrhea in Rectal Samples
|
N/A | |
Completed |
NCT02019771 -
Gonorrhea and Chlamydia HIV-infected Men Who Have Sex With Men
|
||
Completed |
NCT00221364 -
Trachoma Elimination Follow-up
|
Phase 4 | |
Completed |
NCT00140296 -
Using the Healthcare Visit to Improve Contraceptive Use
|
N/A | |
Recruiting |
NCT06187064 -
Combination Primary Care and Prevention Services for Women Who Inject Drugs and Exchange Sex in Seattle, Washington
|
N/A | |
Completed |
NCT03895320 -
Protecting Our Future Generation: Promotion of Protective Sexual Health Practices Among Native American Youth and Young Adults Through an Assets-based Self-care Intervention
|
N/A | |
Completed |
NCT02055742 -
Detection of Chlamydia (CT) and Gonorrhea (NG)
|
N/A | |
Completed |
NCT03090802 -
MAMAS: Mentoring Adolescent Mothers at School
|
N/A |