Tripartite International Research for the Elimination of Trachoma

NCT01202331 | Completed Phase 4 DMC

• 1 other identifier: 10-02169
• Study Type: interventional
• Target: 29,000
• Locations: 1 country
• Sites: 1

Brief Summary

Mass antimicrobial administrations have been remarkably successful in reducing the prevalence of the ocular strains of Chlamydia that cause trachoma. Repeated distributions progressively lower the prevalence of infection, and in some cases may even result in local elimination. Mass treatments cannot be continued forever, due to concerns about cost and antibiotic resistance. The hope has been that other measures such as latrine construction and hygiene programs would prevent infection from returning. Unfortunately, no non-antibiotic measure has yet demonstrated an effect on infection.

1. 1.We hypothesize that Chlamydial infection will return to communities when treatment ends.
2. 2.We hypothesize that infection will be completely eliminated in all communities treated for seven years.
3. 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.

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 36 months versus 0 months for Aim 1, at 36 months for Aim 2 and Aim 3)

  36 months

Secondary Outcomes (9)

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

  36 months

• Childhood mortality (6 months -5 years of age), 6-10 years of age, and >10 years

  36 months

• Macrolide resistance in pneumococcus, Haemophilus influenzae, and Staphylococcus aureus (% resistance over time, clustered by randomization unit)

  36 months

• Anthropometric measurements (weight and height), as outlined by WHO child growth standards (0-5 years of age)

  3, 12, 24, and 36 months after baseline

• Health clinic visits (due to all causes and due to infectious causes) in children aged 6 months-5 years, 6-10 years, and >10 years

  36 months

Study Arms (6)

J

NO INTERVENTION

Stop Annual Treatment

K

NO INTERVENTION

Stop Biannual Treatment

L

OTHER

Continue Annual Treatment

Drug: mass treatment with oral azithromycin

M

OTHER

Continue Biannual Treatment

Drug: mass treatment with oral azithromycin

N

EXPERIMENTAL

Targeted Treatment by Age

Drug: mass treatment with oral azithromycin

O

EXPERIMENTAL

Targeted Treatment by Clinical Exam

Drug: mass treatment with oral azithromycin

Interventions

mass treatment with oral azithromycin 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. 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.

Also known as: Zithromax

L; M; N; O

Eligibility Criteria

• Age: 1 Day+
• 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)

The Carter Center, Ethiopia

Addis Ababa, Ethiopia

Location

Related Publications (3)

• 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.

  PMID: 37021692 DERIVED

• 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.

  PMID: 31166952 DERIVED

• 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.

  PMID: 30106956 DERIVED

MeSH Terms

Conditions

Trachoma; Chlamydia Infections; Bacterial Infections; Eye Diseases

Interventions

Azithromycin

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

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Tom Lietman, MD

  F.I. Proctor Foundation, UCSF

  PRINCIPAL INVESTIGATOR

• Kieran S O'Brien, MPH

  F.I. 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: September 13, 2010
• First Posted: September 15, 2010
• Study Start: November 1, 2010
• Primary Completion: November 1, 2013
• Study Completion: May 1, 2014
• Last Updated: October 11, 2017

Record last verified: 2017-10

Locations

ET (1)