Tripartite International Research for the Elimination of Trachoma
NCT ID: NCT01202331
Last Updated: 2017-10-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
29000 participants
INTERVENTIONAL
2010-11-30
2014-05-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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J
Stop Annual Treatment
No interventions assigned to this group
K
Stop Biannual Treatment
No interventions assigned to this group
L
Continue Annual Treatment
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.
M
Continue Biannual Treatment
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.
N
Targeted Treatment by Age
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.
O
Targeted Treatment by Clinical Exam
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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)
1 Day
ALL
Yes
Sponsors
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University of California, San Francisco
OTHER
Responsible Party
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Thomas M. Lietman
Professor
Principal Investigators
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Tom Lietman, MD
Role: PRINCIPAL_INVESTIGATOR
F.I. Proctor Foundation, UCSF
Kieran S O'Brien, MPH
Role: STUDY_DIRECTOR
F.I. Proctor Foundation, UCSF
Paul Emerson, PhD
Role: STUDY_DIRECTOR
Emory University
Locations
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The Carter Center, Ethiopia
Addis Ababa, , Ethiopia
Countries
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References
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Mahmud H, Haile BA, Tadesse Z, Gebresillasie S, Shiferaw A, Zerihun M, Liu Z, Callahan EK, Cotter SY, Varnado NE, Oldenburg CE, Porco TC, Lietman TM, Keenan JD. Targeted Mass Azithromycin Distribution for Trachoma: A Community-Randomized Trial (TANA II). Clin Infect Dis. 2023 Aug 14;77(3):388-395. doi: 10.1093/cid/ciad211.
Keenan JD, Gebresillasie S, Stoller NE, Haile BA, Tadesse Z, Cotter SY, Ray KJ, Aiemjoy K, Porco TC, Callahan EK, Emerson PM, Lietman TM. Linear growth in preschool children treated with mass azithromycin distributions for trachoma: A cluster-randomized trial. PLoS Negl Trop Dis. 2019 Jun 5;13(6):e0007442. doi: 10.1371/journal.pntd.0007442. eCollection 2019 Jun.
Keenan JD, Tadesse Z, Gebresillasie S, Shiferaw A, Zerihun M, Emerson PM, Callahan K, Cotter SY, Stoller NE, Porco TC, Oldenburg CE, Lietman TM. Mass azithromycin distribution for hyperendemic trachoma following a cluster-randomized trial: A continuation study of randomly reassigned subclusters (TANA II). PLoS Med. 2018 Aug 14;15(8):e1002633. doi: 10.1371/journal.pmed.1002633. eCollection 2018 Aug.
Other Identifiers
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10-02169
Identifier Type: -
Identifier Source: org_study_id