TrachomaPhase 4TANANCT00322972
Trachoma Amelioration in Northern Amhara (TANA)
A Phase 4 study testing Mass treatment with oral azithromycin to an entire community in people with Trachoma and Chlamydia, run by University of California, San Francisco at 1 site in Ethiopia.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year and olderHealthy volunteers can take part
- What is being tested?
- Mass treatment with oral azithromycin to an entire community
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33,000 participants
- Where
- 1 siteEthiopia
- Study dates
- Jun 2006to May 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All residents residing in the state-teams which are randomly selected for this study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Eliminating Trachoma With Repeat Mass Drug Treatment
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.
Read the 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.
- Being tested
- Mass treatment with oral azithromycin to an entire community
- Keywords
- Bacterial Infections, Chlamydia Infections, Eye Diseases
- Medical subject headings
- Trachoma, Chlamydia Infections, Bacterial Infections, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mass treatment with oral azithromycin to an entire communityDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| A | Other | Annual mass treatment Receives: Drug: Mass treatment with oral azithromycin to an entire community |
| B | Other | Biannual mass treatment Receives: Drug: Mass treatment with oral azithromycin to an entire community |
| C | Experimental | Mass administration of antibiotic; treatment of children (1-10 years of age) only Receives: Drug: Mass treatment with oral azithromycin to an entire community |
| D | No intervention | Delayed initiation of mass administration of antibiotic |
| F | Other | One-time mass administration only Receives: Drug: Mass treatment with oral azithromycin to an entire community |
| G | Experimental | One-time mass administration of antibiotics, plus intensive latrine construction Receives: Drug: Mass treatment with oral azithromycin to an entire community |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 42 months
Secondary outcomes (5)
Clinical active trachoma in community, as determined by the WHO simplified grading system
Measured: 42 months
Childhood (>= 1 year of age) mortality, analyzed as 1-5, 6-10 years of age, and total
Measured: 42 months
Macrolide resistance in pneumococcus (% resistance over time, clustered by randomization unit)
Measured: 42 months
Average prevalence of ocular chlamydia infection in annually and biennially treated communities as determined by pooled NAAT (Nucleic Acid Amplification Test)
Measured: 48 months
Diversity measure in the conjunctival and nasopharyngeal microbiomes of children (age 0-9)
Measured: 0, 6, 12, 18, 24, 30, 36, 42, and 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2006 (estimated)
- Study startJun 2006
- Primary completionNov 2009
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for TrachomaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas M. Lietman, University of California, San Francisco
- Investigators
- Tom Lietman, MD, Principal investigator, Proctor Foundation, UCSFKieran S O'Brien, MPH, Study director, Proctor Foundation, UCSFPaul Emerson, PhD, Study director, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00322972
- Sponsor's protocol ID
- 10-02576
- Acronym
- TANA
- Status last verified
- Sep 2015
- First submitted
- 5 May 2006
- Last updated
- 9 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Skalet AH, Cevallos V, Ayele B, Gebre T, Zhou Z, Jorgensen JH, Zerihun M, Habte D, Assefa Y, Emerson PM, Gaynor BD, Porco TC, Lietman TM, Keenan JD. Antibiotic selection pressure and macrolide resistance in nasopharyngeal Streptococcus pneumoniae: a cluster-randomized clinical trial. PLoS Med. 2010 Dec 14;7(12):e1000377. doi: 10.1371/journal.pmed.1000377.
PubMed 21179434Porco TC, Gebre T, Ayele B, House J, Keenan J, Zhou Z, Hong KC, Stoller N, Ray KJ, Emerson P, Gaynor BD, Lietman TM. Effect of mass distribution of azithromycin for trachoma control on overall mortality in Ethiopian children: a randomized trial. JAMA. 2009 Sep 2;302(9):962-8. doi: 10.1001/jama.2009.1266.
PubMed 19724043Keenan JD, Ayele B, Gebre T, Zerihun M, Zhou Z, House JI, Gaynor BD, Porco TC, Emerson PM, Lietman TM. Childhood mortality in a cohort treated with mass azithromycin for trachoma. Clin Infect Dis. 2011 Apr 1;52(7):883-8. doi: 10.1093/cid/cir069.
PubMed 21427395Lietman TM, Gebre T, Ayele B, Ray KJ, Maher MC, See CW, Emerson PM, Porco TC; TANA Study Group. The epidemiological dynamics of infectious trachoma may facilitate elimination. Epidemics. 2011 Jun;3(2):119-24. doi: 10.1016/j.epidem.2011.03.004. Epub 2011 Apr 6.
PubMed 21624783Stoller NE, Gebre T, Ayele B, Zerihun M, Assefa Y, Habte D, Zhou Z, Porco TC, Keenan JD, House JI, Gaynor BD, Lietman TM, Emerson PM. Efficacy of latrine promotion on emergence of infection with ocular Chlamydia trachomatis after mass antibiotic treatment: a cluster-randomized trial. Int Health. 2011 Jun;3(2):75-84. doi: 10.1016/j.inhe.2011.03.004.
PubMed 21785663Keenan JD, See CW, Moncada J, Ayele B, Gebre T, Stoller NE, McCulloch CE, Porco TC, Gaynor BD, Emerson PM, Schachter J, Lietman TM. Diagnostic characteristics of tests for ocular Chlamydia after mass azithromycin distributions. Invest Ophthalmol Vis Sci. 2012 Jan 25;53(1):235-40. doi: 10.1167/iovs.11-8493.
PubMed 22159017Gebre T, Ayele B, Zerihun M, House JI, Stoller NE, Zhou Z, Ray KJ, Gaynor BD, Porco TC, Emerson PM, Lietman TM, Keenan JD. Latrine promotion for trachoma: assessment of mortality from a cluster-randomized trial in Ethiopia. Am J Trop Med Hyg. 2011 Sep;85(3):518-23. doi: 10.4269/ajtmh.2011.10-0720.
PubMed 21896815House JI, Ayele B, Porco TC, Zhou Z, Hong KC, Gebre T, Ray KJ, Keenan JD, Stoller NE, Whitcher JP, Gaynor BD, Emerson PM, Lietman TM. Assessment of herd protection against trachoma due to repeated mass antibiotic distributions: a cluster-randomised trial. Lancet. 2009 Mar 28;373(9669):1111-8. doi: 10.1016/S0140-6736(09)60323-8.
PubMed 19329003Gebre T, Ayele B, Zerihun M, Genet A, Stoller NE, Zhou Z, House JI, Yu SN, Ray KJ, Emerson PM, Keenan JD, Porco TC, Lietman TM, Gaynor BD. Comparison of annual versus twice-yearly mass azithromycin treatment for hyperendemic trachoma in Ethiopia: a cluster-randomised trial. Lancet. 2012 Jan 14;379(9811):143-51. doi: 10.1016/S0140-6736(11)61515-8. Epub 2011 Dec 20.
PubMed 22192488Ray KJ, Zhou Z, Cevallos V, Chin S, Enanoria W, Lui F, Lietman TM, Porco TC. Estimating community prevalence of ocular Chlamydia trachomatis infection using pooled polymerase chain reaction testing. Ophthalmic Epidemiol. 2014 Apr;21(2):86-91. doi: 10.3109/09286586.2014.884600.
PubMed 24621121Keenan JD, Ayele B, Gebre T, Moncada J, Stoller NE, Zhou Z, Porco TC, McCulloch CE, Gaynor BD, Emerson PM, Schachter J, Lietman TM. Ribosomal RNA evidence of ocular Chlamydia trachomatis infection following 3 annual mass azithromycin distributions in communities with highly prevalent trachoma. Clin Infect Dis. 2012 Jan 15;54(2):253-6. doi: 10.1093/cid/cir791. Epub 2011 Nov 17.
PubMed 22095569
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eliminating Trachoma With Repeat Mass Drug Treatment
- ClinicalTrials.gov ID
- NCT00322972
- Acronym / sponsor ID
- TANA / 10-02576
- Keywords
- Bacterial Infections, Chlamydia Infections, Eye Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33,000 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Nov 2009 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 9 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| A | Other | Drug: Mass treatment with oral azithromycin to an entire communityAnnual mass treatment |
| B | Other | Drug: Mass treatment with oral azithromycin to an entire communityBiannual mass treatment |
| C | Experimental | Drug: Mass treatment with oral azithromycin to an entire communityMass administration of antibiotic; treatment of children (1-10 years of age) only |
| D | No intervention | –Delayed initiation of mass administration of antibiotic |
| F | Other | Drug: Mass treatment with oral azithromycin to an entire communityOne-time mass administration only |
| G | Experimental | Drug: Mass treatment with oral azithromycin to an entire communityOne-time mass administration of antibiotics, plus intensive latrine construction |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All residents residing in the state-teams which are randomly selected for this study.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mass treatment with oral azithromycin to an entire communityFor 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. | Drug | A, B, C, F, G |
Primary outcome
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
5 secondary outcomes
Clinical active trachoma in community, as determined by the WHO simplified grading system
Time frame: 42 months
Childhood (>= 1 year of age) mortality, analyzed as 1-5, 6-10 years of age, and total
Time frame: 42 months
Macrolide resistance in pneumococcus (% resistance over time, clustered by randomization unit)
Time frame: 42 months
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2015.
- Background: PubMed 21179434Skalet AH, Cevallos V, Ayele B, Gebre T, Zhou Z, Jorgensen JH, Zerihun M, Habte D, Assefa Y, Emerson PM, Gaynor BD, Porco TC, Lietman TM, Keenan JD. Antibiotic selection pressure and macrolide resistance in nasopharyngeal Streptococcus pneumoniae: a cluster-randomized clinical trial. PLoS Med. 2010 Dec 14;7(12):e1000377. doi: 10.1371/journal.pmed.1000377.
- Background: PubMed 19724043Porco TC, Gebre T, Ayele B, House J, Keenan J, Zhou Z, Hong KC, Stoller N, Ray KJ, Emerson P, Gaynor BD, Lietman TM. Effect of mass distribution of azithromycin for trachoma control on overall mortality in Ethiopian children: a randomized trial. JAMA. 2009 Sep 2;302(9):962-8. doi: 10.1001/jama.2009.1266.
- Background: PubMed 21427395Keenan JD, Ayele B, Gebre T, Zerihun M, Zhou Z, House JI, Gaynor BD, Porco TC, Emerson PM, Lietman TM. Childhood mortality in a cohort treated with mass azithromycin for trachoma. Clin Infect Dis. 2011 Apr 1;52(7):883-8. doi: 10.1093/cid/cir069.
- Background: PubMed 21624783Lietman TM, Gebre T, Ayele B, Ray KJ, Maher MC, See CW, Emerson PM, Porco TC; TANA Study Group. The epidemiological dynamics of infectious trachoma may facilitate elimination. Epidemics. 2011 Jun;3(2):119-24. doi: 10.1016/j.epidem.2011.03.004. Epub 2011 Apr 6.
- Background: PubMed 21785663Stoller NE, Gebre T, Ayele B, Zerihun M, Assefa Y, Habte D, Zhou Z, Porco TC, Keenan JD, House JI, Gaynor BD, Lietman TM, Emerson PM. Efficacy of latrine promotion on emergence of infection with ocular Chlamydia trachomatis after mass antibiotic treatment: a cluster-randomized trial. Int Health. 2011 Jun;3(2):75-84. doi: 10.1016/j.inhe.2011.03.004.
- Background: PubMed 22159017Keenan JD, See CW, Moncada J, Ayele B, Gebre T, Stoller NE, McCulloch CE, Porco TC, Gaynor BD, Emerson PM, Schachter J, Lietman TM. Diagnostic characteristics of tests for ocular Chlamydia after mass azithromycin distributions. Invest Ophthalmol Vis Sci. 2012 Jan 25;53(1):235-40. doi: 10.1167/iovs.11-8493.
- Background: PubMed 21896815Gebre T, Ayele B, Zerihun M, House JI, Stoller NE, Zhou Z, Ray KJ, Gaynor BD, Porco TC, Emerson PM, Lietman TM, Keenan JD. Latrine promotion for trachoma: assessment of mortality from a cluster-randomized trial in Ethiopia. Am J Trop Med Hyg. 2011 Sep;85(3):518-23. doi: 10.4269/ajtmh.2011.10-0720.
- Results publication: PubMed 19329003House JI, Ayele B, Porco TC, Zhou Z, Hong KC, Gebre T, Ray KJ, Keenan JD, Stoller NE, Whitcher JP, Gaynor BD, Emerson PM, Lietman TM. Assessment of herd protection against trachoma due to repeated mass antibiotic distributions: a cluster-randomised trial. Lancet. 2009 Mar 28;373(9669):1111-8. doi: 10.1016/S0140-6736(09)60323-8.
- Results publication: PubMed 22192488Gebre T, Ayele B, Zerihun M, Genet A, Stoller NE, Zhou Z, House JI, Yu SN, Ray KJ, Emerson PM, Keenan JD, Porco TC, Lietman TM, Gaynor BD. Comparison of annual versus twice-yearly mass azithromycin treatment for hyperendemic trachoma in Ethiopia: a cluster-randomised trial. Lancet. 2012 Jan 14;379(9811):143-51. doi: 10.1016/S0140-6736(11)61515-8. Epub 2011 Dec 20.
- Derived from this study: PubMed 24621121Ray KJ, Zhou Z, Cevallos V, Chin S, Enanoria W, Lui F, Lietman TM, Porco TC. Estimating community prevalence of ocular Chlamydia trachomatis infection using pooled polymerase chain reaction testing. Ophthalmic Epidemiol. 2014 Apr;21(2):86-91. doi: 10.3109/09286586.2014.884600.
- Derived from this study: PubMed 22095569Keenan JD, Ayele B, Gebre T, Moncada J, Stoller NE, Zhou Z, Porco TC, McCulloch CE, Gaynor BD, Emerson PM, Schachter J, Lietman TM. Ribosomal RNA evidence of ocular Chlamydia trachomatis infection following 3 annual mass azithromycin distributions in communities with highly prevalent trachoma. Clin Infect Dis. 2012 Jan 15;54(2):253-6. doi: 10.1093/cid/cir791. Epub 2011 Nov 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom Lietman, MD principal investigator
Proctor Foundation, UCSF
Kieran S O'Brien, MPH study director
Proctor Foundation, UCSF
Paul Emerson, PhD study director
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mass treatment with oral azithromycin to an entire community in people with Trachoma and Chlamydia, run by University of California, San Francisco at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00322972, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2015; AzTrials last refreshed its copy on 7 Nov 2026.