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WithdrawnNCT02176057NETSUpdated May 21, 2015

Nepal Elimination of Trachoma Study

A Phase 2/3 interventional study of Azithromycin in Trachoma, sponsored by University of California, San Francisco. Withdrawn at 1 site in Nepal. Open to participants aged 1 Year to 9 Years. Per ClinicalTrials.gov, last updated 2015-05-21.

Sponsored by University of California, San Francisco · Phase 2/3, Interventional, and Treatment

Why this study was withdrawn
Nepal Ministry of Health implemented public drug treatment prior to the proposed start date
Phase
Phase 2/3
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
1 Year to 9 Years
Sex
All
01

Study summary

The main purpose of this study is to determine if ocular Chlamydia trachomatis infection can be eliminated in communities in Nepal following mass antibiotic distributions with azithromycin. The investigators will study both clinical trachoma and ocular C. trachomatis infection. The overall objective is to determine if the current World Health Organization (WHO) treatment strategy results in elimination of trachoma and infection.

  1. The investigators hypothesize that 24 communities in Kanchanpur, Kailali, and Achham districts of Nepal which receive mass antibiotic treatments will achieve elimination of trachoma as a public health problem (clinical disease \<5% in children 1-9 years old) more frequently than communities which have not received antibiotic treatments.
  2. The investigators hypothesize that infection with C. trachomatis will be undetectable in all members within a community following mass treatment as determined by the most highly sensiti1. The investigators hypothesize that 24 communities in Kanchanpur, Kailali, and Achham districts of Nepal which receive mass antibiotic treatments will achieve elimination of trachoma as a public health problem (clinical disease \<5% in children 1-9 years old) more frequently than communities which have not received antibiotic treatments.
  1. The investigators hypothesize that infection with C. trachomatis will be undetectable in all members within a community following mass treatment as determined by the most highly sensitive nucleic acid amplification testing available (mRNA-based APTIMA and DNA-based AMPLICOR PCR).ve nucleic acid amplification testing available (mRNA-based APTIMA and DNA-based AMPLICOR PCR).
Read the detailed description

Here we evaluate whether ocular chlamydia infection and clinical trachoma are eliminated from 24 communities in western Nepal following a mass antibiotic distribution program. It is unknown if repeated treatments should continue or can be stopped thereby minimizing side effects and the high cost of medicine distribution. The investigators plan to randomize individuals to two groups to study the effects of a mass antibiotic distribution program: 1) treatment of antibiotics and 2) delayed treatment of antibiotics (after 4-6 months).

02

Conditions studied

  • Trachoma

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Keywords

  • trachoma
03

In context

Trachoma

39 studies on the registry are indexed under Trachoma; 3 are open to participants now.

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Lead sponsor

University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.

Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.

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04

Who can participate

Ages eligible
1 Year to 9 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Children aged 1-9 years
  • Children who live in Kailai, Kanchanpur, or Achham Districts of Nepal

Exclusion criteria

Exclusion Criteria:

  • All individuals who are allergic to macrolides
  • All pregnant woman
  • All neonates
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Antibiotic

    Azithromycin, suspension (liquid), 1 gram, one-time dose

    Drug: Azithromycin

  • No intervention
    Observation

Interventions

06

What researchers measure

Primary outcomes

  1. Trachoma (clinical and C. trachomatis)

    Time frame: 12 months

Secondary outcomes

  1. Anthropometry (height for weight)

    Time frame: 12 months

  2. Malaria

    Time frame: 12 months

07

Study locations

1 site
  • Geta Eye Hospital
    Geta, Kailali 10900, Nepal
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2014 and a primary completion of Aug 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 24, 2014
First posted
Jun 26, 2014
Start
Aug 2014
Primary completionActual
Aug 2014
Last update
May 21, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 21, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02176057
Lead sponsor
University of California, San Francisco
Collaborators
National Eye Institute (NEI)
Responsible party
Sponsor
First posted
Jun 26, 2014
Start date
Aug 2014
Primary completion
Aug 2014
Last update
May 21, 2015

Study contacts

Bruce D Gaynor, MD
principal investigator · UCSF F. I. Proctor Foundation (California, USA)
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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