Tripartite International Research for the Elimination of Trachoma (TIRET)
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Purpose
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.
- We hypothesize that Chlamydial infection will return to communities when treatment ends.
- We hypothesize that infection will be completely eliminated in all communities treated for seven years.
- 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Trachoma Chlamydia |
Drug: mass treatment with oral azithromycin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Tripartite International Research for the Elimination of Trachoma |
- The average prevalence of ocular chlamydia infection in communities in an arm as determined by pooled NAAT (Nucleic Acid Amplification Test)(at 36 months versus 0 months for Aim 1, at 36 months for Aim 2 and Aim 3) [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- Clinical active trachoma in community, as determined by the WHO simplified grading system [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- Childhood mortality (6 months -5 years of age), 6-10 years of age, and >10 years [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- Macrolide resistance in pneumococcus, Haemophilus influenzae, and Staphylococcus aureus (% resistance over time, clustered by randomization unit) [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- Anthropometric measurements (weight for height), as outlined by WHO child growth standards (0-5 years of age) [ Time Frame: 3, 12, 24, and 36 months after baseline ] [ Designated as safety issue: No ]
- Health clinic visits (due to all causes and due to infectious causes) in children aged 6 months-5 years, 6-10 years, and >10 years [ Time Frame: 36 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 35000 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: J
Stop Annual Treatment
|
|
|
No Intervention: K
Stop Biannual Treatment
|
|
|
L
Continue Annual Treatment
|
Drug: mass treatment with oral azithromycin
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. Nasopharyngeal swabs will be collected in each community from 15 randomly selected children among the 60 participants under age 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.
Other Name: Zithromax
|
|
M
Continue Biannual Treatment
|
Drug: mass treatment with oral azithromycin
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. Nasopharyngeal swabs will be collected in each community from 15 randomly selected children among the 60 participants under age 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.
Other Name: Zithromax
|
|
Experimental: N
Targeted Treatment by Age
|
Drug: mass treatment with oral azithromycin
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. Nasopharyngeal swabs will be collected in each community from 15 randomly selected children among the 60 participants under age 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.
Other Name: Zithromax
|
|
Experimental: O
Targeted Treatment by Clinical Exam
|
Drug: mass treatment with oral azithromycin
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. Nasopharyngeal swabs will be collected in each community from 15 randomly selected children among the 60 participants under age 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.
Other Name: Zithromax
|
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 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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts 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 exclusion criteria will not be given the study antibiotic azithromycin, but offered the current WHO-recommended alternative treatment to azithromycin for active trachoma, which is 1% tetracycline eye ointment, to be used twice a day, topically to both eyes, for six weeks. Note that the exclusion criteria refer to the exclusion to the treatment drug, but not to the monitoring, treatment of trachoma, and examinations.
Contacts and Locations| Contact: Tom Lietman, MD | (415) 502-2662 | tom.lietman@ucsf.edu |
| Contact: Nicole Stoller, MPH | 415.476.2460 | nicole.stoller@ucsf.edu |
| Ethiopia | |
| The Carter Center, Ethiopia | Recruiting |
| Addis Ababa, Ethiopia | |
| Contact: Sintayehu Gebresillasie, MSc +251 11 663 1863 sint_selam@yahoo.com | |
| Contact: Zerihun Tadesse, MD, MPH +251 11 663 1863 global2000@telecom.net.et | |
| Principal Investigator: | Tom Lietman, MD | F.I. Proctor Foundation, UCSF |
| Study Director: | Nicole Stoller, MPH | F.I. Proctor Foundation, UCSF |
| Study Director: | Sintayehu Gebresillasie, MSc | The Carter Center, Ethiopia |
| Study Director: | Paul Emerson, PhD | The Carter Center, Atlanta |
More Information
No publications provided
| Responsible Party: | Thomas M. Lietman, Professor, University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT01202331 History of Changes |
| Other Study ID Numbers: | 10-02169 |
| Study First Received: | September 13, 2010 |
| Last Updated: | May 20, 2013 |
| Health Authority: | United States: Institutional Review Board Ethiopia: Ethiopia Science and Technology Commission |
Keywords provided by University of California, San Francisco:
|
Bacterial Infections Chlamydia Infections Eye Diseases |
Additional relevant MeSH terms:
|
Chlamydia Infections Trachoma Chlamydiaceae Infections Gram-Negative Bacterial Infections Bacterial Infections Sexually Transmitted Diseases, Bacterial Sexually Transmitted Diseases Infection Genital Diseases, Male Genital Diseases, Female Conjunctivitis, Bacterial |
Eye Infections, Bacterial Eye Infections Conjunctivitis Conjunctival Diseases Eye Diseases Corneal Diseases Azithromycin Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 13, 2013