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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
KETFO Trial 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.Check my eligibility
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.See study design
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.
KETFO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ocular chlamydia measured in a population based age-stratified sample of the entire community
Secondary outcome measures
Conjunctival inflammation
Genus Chlamydia
Seropositivity to C. trachomatis antibodies CT694 and Pgp3
Side effects data
From 2018 Phase 4 trial • 190238 Patients • NCT020479813%
Death
100%
80%
60%
40%
20%
0%
Study treatment Arm
Biannual Mass Oral Placebo
Biannual Mass Oral Azithromycin
KETFO 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
Completed Phase 4
~274950
Find a Location
Who is running the clinical trial?
National Eye Institute (NEI)NIH
546 Previous Clinical Trials
1,081,928 Total Patients Enrolled
5 Trials studying Trachoma
540,052 Patients Enrolled for Trachoma
Bahir Dar UniversityOTHER
8 Previous Clinical Trials
12,984 Total Patients Enrolled
Eyu-EthiopiaUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: PCR infection-based core group
- Group 2: TI-based core group
- Group 3: WHO-recommended
- Group 4: Age-based core group
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has enrollment for this trial opened yet?
"The data hosted on clinicaltrials.gov indicates that enrollment for this trial is currently ongoing. The study was first advertised to the public on February 7th 2022 and has been revised most recently on February 22nd of this year."
Answered by AI
In what contexts is Azithromycin typically administered?
"Azithromycin can be used to treat genital ulcer disease (GUD), the genus chlamydia, and adults presenting with relevant symptoms."
Answered by AI
What adverse effects might one experience from taking Azithromycin?
"Azithromycin is highly regarded as a safe medication, so it was given 3 out of 3 rating. This drug has also been approved after Phase 4 trials."
Answered by AI
What additional data has been compiled regarding Azithromycin?
"Currently, there is an abundance of clinical trials dedicated to scrutinizing the efficacy of Azithromycin. The majority are in their third phase and 18 studies have been launched in total. Such experiments occur all across 694 different facilities, with a primary concentration located in Albuquerque, New mexico."
Answered by AI
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