Trachoma Amelioration in Northern Amhara (TANA)

NCT00322972 | Completed Phase 4 DMC

• 1 other identifier: 10-02576
• Study Type: interventional
• Target: 33,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Trachoma; Chlamydia

Keywords

Bacterial Infections; Chlamydia Infections; Eye Diseases

Outcome Measures

Primary Outcomes (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)

  42 months

Secondary Outcomes (5)

• Clinical active trachoma in community, as determined by the WHO simplified grading system

  42 months

• Childhood (>= 1 year of age) mortality, analyzed as 1-5, 6-10 years of age, and total

  42 months

• Macrolide resistance in pneumococcus (% resistance over time, clustered by randomization unit)

  42 months

• Average prevalence of ocular chlamydia infection in annually and biennially treated communities as determined by pooled NAAT (Nucleic Acid Amplification Test)

  48 months

• Diversity measure in the conjunctival and nasopharyngeal microbiomes of children (age 0-9)

  0, 6, 12, 18, 24, 30, 36, 42, and 48 months

Study Arms (6)

A

OTHER

Annual mass treatment

Drug: Mass treatment with oral azithromycin to an entire community

B

OTHER

Biannual mass treatment

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

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

Drug: Mass treatment with oral azithromycin to an entire community

G

EXPERIMENTAL

One-time mass administration of antibiotics, plus intensive latrine construction

Drug: Mass treatment with oral azithromycin to an entire community

Interventions

Mass treatment with oral azithromycin to an entire community DRUG

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.

A; B; C; F; G

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All residents residing in the state-teams which are randomly selected for this study.

You may not qualify if:

• Pregnant women
• Children under 6 months of age
• All those who are allergic to macrolides or azalides

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

Carter Center, Ethiopia

Addis Ababa, Ethiopia

Location

Related Publications (11)

• 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.

  PMID: 21179434 BACKGROUND

• Porco 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.

  PMID: 19724043 BACKGROUND

• Keenan 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.

  PMID: 21427395 BACKGROUND

• Lietman 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.

  PMID: 21624783 BACKGROUND

• Stoller 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.

  PMID: 21785663 BACKGROUND

• Keenan 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.

  PMID: 22159017 BACKGROUND

• Gebre 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.

  PMID: 21896815 BACKGROUND

• House 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.

  PMID: 19329003 RESULT

• Gebre 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.

  PMID: 22192488 RESULT

• Ray 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.

  PMID: 24621121 DERIVED

• Keenan 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.

  PMID: 22095569 DERIVED

MeSH Terms

Conditions

Trachoma; Chlamydia Infections; Bacterial Infections; Eye Diseases

Condition Hierarchy (Ancestors)

Conjunctivitis, Bacterial; Eye Infections, Bacterial; Bacterial Infections and Mycoses; Infections; Chlamydiaceae Infections; Gram-Negative Bacterial Infections; Eye Infections; Conjunctivitis; Conjunctival Diseases; Corneal Diseases; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases

Study Officials

• Tom Lietman, MD

  Proctor Foundation, UCSF

  PRINCIPAL INVESTIGATOR

• Kieran S O'Brien, MPH

  Proctor Foundation, UCSF

  STUDY DIRECTOR

• Paul Emerson, PhD

  Emory University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 5, 2006
• First Posted: May 9, 2006
• Study Start: June 1, 2006
• Primary Completion: November 1, 2009
• Study Completion: May 1, 2014
• Last Updated: September 9, 2015

Record last verified: 2015-09

Locations

ET (1)