← Back to Search

Macrolide Antibiotic

Azithromycin for Trachoma (KETFO Trial)

Phase 4

Recruiting

Led By Tom M Lietman, MD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial will compare two strategies for distributing azithromycin to see if one is more effective than the other at eliminating trachoma.

Who is the study for?

This trial is for everyone in certain communities where trachoma, an eye infection that can cause blindness, is common. People of all ages can get azithromycin annually as per WHO guidelines. Only those who don't agree to participate are excluded.

What is being tested?

The study tests if giving out azithromycin more intensively and targeting specific areas works better for getting rid of trachoma than the current WHO method of handing it out once a year to everyone.

What are the potential side effects?

Azithromycin may lead to side effects like stomach upset, diarrhea, nausea, and rarely more serious issues such as allergic reactions or heart problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Ocular chlamydia measured in a population based age-stratified sample of the entire community

Secondary study objectives

Conjunctival inflammation

Genus Chlamydia

Seropositivity to C. trachomatis antibodies CT694 and Pgp3

Side effects data

From 2022 Phase 4 trial • 42 Patients • NCT05027516

pain at injection site

100%

80%

60%

40%

20%

Study treatment Arm

Rocephine®

Rocephine® + Azithromycin

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: TI-based core groupExperimental Treatment1 Intervention

Annual mass azithromycin treatment plus quarterly treatment of a conjunctival photography-based cohort that would be a subset of the age-based core group

Group II: PCR infection-based core groupExperimental Treatment1 Intervention

Annual mass azithromycin treatment plus quarterly treatment of a PCR-based cohort that would be a subset of the age-based core group.

Group III: Age-based core groupExperimental Treatment1 Intervention

Annual mass azithromycin treatment of everyone plus quarterly treatment of children

Group IV: WHO-recommendedActive Control1 Intervention

Annual mass azithromycin distribution of all residents

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Azithromycin

2018