Trachoma Amelioration in Northern Amhara (TANA) - Full Text View

Sponsored by:	University of California, San Francisco
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00322972

Purpose

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	Intervention	Phase
Trachoma Chlamydia	Drug: Mass treatment with oral azithromycin to an entire community	Phase IV

MedlinePlus related topics: Antibiotics Bacterial Infections Chlamydia Infections Eye Infections

Drug Information available for: Azithromycin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Eliminating Trachoma With Repeat Mass Drug Treatment

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical active trachoma in community, as determined by the WHO simplified grading system [ Time Frame: 42 months ] [ Designated as safety issue: No ]
Childhood (>= 1 year of age) mortality, analyzed as 1-5, 6-10 years of age, and total [ Time Frame: 42 months ] [ Designated as safety issue: No ]
Macrolide resistance in pneumococcus (% resistance over time, clustered by randomization unit) [ Time Frame: 42 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	36000
Study Start Date:	June 2006
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.
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 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.
D: No Intervention Delayed initiation of mass administration of antibiotic	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.
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.
G: Experimental 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.

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.

Eligibility

Ages Eligible for Study:	1 Year and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00322972

Contacts

Contact: Tom Lietman, MD	(415) 502-2662	tom.lietman@ucsf.edu
Contact: Jenafir House, MPH, MSW	(415) 514-1616	jenafir.house@ucsf.edu

Locations

Ethiopia
Carter Center, Ethiopia	Recruiting
Addis Ababa, Ethiopia
Contact: Berhan Ayele, MSc +251 (-1) 18 33 53 berhanayele@yahoo.com
Contact: Teshome Gebre, MPH, MBA +251 (-1) 18 33 53 global2000@telecom.net.et

Sponsors and Collaborators

University of California, San Francisco

Investigators

Principal Investigator:	Tom Lietman, MD	Proctor Foundation, UCSF
Study Director:	Jenafir House, MPH, MSW	Proctor Foundation, UCSF
Study Director:	Berhan Ayele, MSc	Carter Center, Ethiopia
Study Director:	Paul Emerson, MD	Emory University

More Information

No publications provided by University of California, San Francisco

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Responsible Party:	Proctor Foundation ( Thomas Lietman, MD )
Study ID Numbers:	H9332-26016-04B, 5-U10 EY016214-04
Study First Received:	May 5, 2006
Last Updated:	January 22, 2009
ClinicalTrials.gov Identifier:	NCT00322972 History of Changes
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

Study placed in the following topic categories:

Bacterial Infections
Corneal Diseases
Eye Infections, Bacterial
Conjunctivitis, Bacterial
Eye Diseases
Eye Infections
Conjunctivitis
Genital Diseases, Male

Conjunctival Diseases
Trachoma
Gram-Negative Bacterial Infections
Genital Diseases, Female
Anti-Bacterial Agents
Azithromycin
Chlamydia Infections
Sexually Transmitted Diseases

Additional relevant MeSH terms:

Bacterial Infections
Anti-Infective Agents
Corneal Diseases
Sexually Transmitted Diseases, Bacterial
Eye Infections, Bacterial
Conjunctivitis, Bacterial
Eye Diseases
Eye Infections
Conjunctivitis
Infection
Genital Diseases, Male

Pharmacologic Actions
Conjunctival Diseases
Trachoma
Gram-Negative Bacterial Infections
Genital Diseases, Female
Anti-Bacterial Agents
Chlamydiaceae Infections
Therapeutic Uses
Azithromycin
Chlamydia Infections
Sexually Transmitted Diseases

ClinicalTrials.gov processed this record on May 07, 2009