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Trachoma Amelioration in Northern Amhara (TANA) (TANA)

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ClinicalTrials.gov Identifier: NCT00322972
Recruitment Status : Completed
First Posted : May 9, 2006
Last Update Posted : September 9, 2015
Sponsor:
Information provided by (Responsible Party):
Thomas M. Lietman, University of California, San Francisco

Study Description
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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.

Condition or disease Intervention/treatment Phase
Trachoma Chlamydia Drug: Mass treatment with oral azithromycin to an entire community Phase 4

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Eliminating Trachoma With Repeat Mass Drug Treatment
Study Start Date : June 2006
Actual Primary Completion Date : November 2009
Actual Study Completion Date : May 2014

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
A
Annual mass treatment
 Drug: Mass 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.
B
Biannual mass treatment
 Drug: Mass 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.
Experimental: C
Mass administration of antibiotic; treatment of children (1-10 years of age) only
 Drug: Mass 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.
No Intervention: D
Delayed initiation of mass administration of antibiotic
F
One-time mass administration only
 Drug: Mass 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.
Experimental: G
One-time mass administration of antibiotics, plus intensive latrine construction
 Drug: Mass 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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) [ Time Frame: 42 months ]

Secondary Outcome Measures :
  1. Clinical active trachoma in community, as determined by the WHO simplified grading system [ Time Frame: 42 months ]
  2. Childhood (>= 1 year of age) mortality, analyzed as 1-5, 6-10 years of age, and total [ Time Frame: 42 months ]
  3. Macrolide resistance in pneumococcus (% resistance over time, clustered by randomization unit) [ Time Frame: 42 months ]
  4. Average prevalence of ocular chlamydia infection in annually and biennially treated communities as determined by pooled NAAT (Nucleic Acid Amplification Test) [ Time Frame: 48 months ]
  5. Diversity measure in the conjunctival and nasopharyngeal microbiomes of children (age 0-9) [ Time Frame: 0, 6, 12, 18, 24, 30, 36, 42, and 48 months ]

Eligibility Criteria
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Ages Eligible for Study:   1 Year and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00322972


Locations
Ethiopia
Carter Center, Ethiopia
Addis Ababa, Ethiopia
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Tom Lietman, MD Proctor Foundation, UCSF
Study Director: Kieran S O'Brien, MPH Proctor Foundation, UCSF
Study Director: Paul Emerson, PhD Emory University
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Thomas M. Lietman, Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00322972     History of Changes
Other Study ID Numbers: 10-02576
First Posted: May 9, 2006    Key Record Dates
Last Update Posted: September 9, 2015
Last Verified: September 2015

Keywords provided by Thomas M. Lietman, 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