Azithromycin for Trachoma

(KETFO Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Tom Lietman, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: University of California, San Francisco

Disqualifiers: Non-consent

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The investigators propose a cluster-randomized clinical trial to determine whether an intensive, targeted azithromycin distribution strategy is effective for elimination of trachoma at the kebele level compared to the World Health Organization (WHO) recommendation of annual azithromycin distribution.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the drug Azithromycin for treating trachoma?

Research shows that a single oral dose of Azithromycin is effective in treating trachoma, with 78% of patients showing improvement, similar to conventional treatments. Additionally, Azithromycin has been used successfully in mass treatments to reduce trachoma infections in communities. ^{1 2 3 4 5}

Is azithromycin safe for humans?

Azithromycin is generally safe for humans, with side effects like diarrhea and abdominal pain occurring in about 12% of patients, mostly mild or moderate. In mass treatments for trachoma, adverse events were reported in 4.9% to 18.7% of people, but the treatment was well tolerated. ^{2 6 7 8 9}

How is the drug Azithromycin unique in treating trachoma?

Azithromycin is unique for trachoma treatment because it can be administered as a 1.5% eye drop solution, which is effective with a short 3-day treatment, compared to longer courses of other antibiotics. This makes it more convenient and potentially better tolerated, especially for children. ^{1 2 3 4 10}

Research Team

Hadley Burroughs, MSPH

Principal Investigator

University of California, San Francisco

Tom Lietman, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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.

Inclusion Criteria

All individuals in all communities will be eligible for annual mass azithromycin distribution per WHO guidelines.

Exclusion Criteria

Those who do not consent.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Annual mass azithromycin distribution with additional quarterly targeted treatments based on trial arm

36 months

Annual visits for mass distribution, quarterly visits for targeted treatment

Follow-up

Participants are monitored for ocular chlamydia prevalence and other secondary outcomes

36 months

Annual assessments at 12, 24, and 36 months

Treatment Details

Interventions

• Azithromycin (Macrolide Antibiotic)

Trial Overview 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.

Participant Groups

Group I: TI-based core group Experimental Treatment 1 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 group Experimental Treatment 1 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 group Experimental Treatment 1 Intervention

Annual mass azithromycin treatment of everyone plus quarterly treatment of children

Group IV: WHO-recommended Active Control 1 Intervention

Annual mass azithromycin distribution of all residents

Azithromycin is already approved in Canada for the following indications:

Approved in Canada as Azithromycin for:

• Respiratory tract infections
• Skin and soft tissue infections
• Sexually transmitted diseases
• Toxoplasmosis
• Malaria
• Preterm prelabor rupture of membranes

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Suresh Gunasekaran

University of California, San Francisco

Chief Executive Officer since 2022

MBA from Southern Methodist University

Dr. Lukejohn Day

University of California, San Francisco

Chief Medical Officer

MD from Stanford University School of Medicine

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+

Dr. Michael F. Chiang

National Eye Institute (NEI)

Chief Executive Officer since 2020

MD from Harvard Medical School

Dr. Richard Lee

National Eye Institute (NEI)

Chief Medical Officer since 2021

MD, PhD from Harvard Medical School

Bahir Dar University

Collaborator

Trials

10

Recruited

330,000+

Eyu-Ethiopia

Collaborator

Trials

1

Recruited

320,000+

Findings from Research

In a study involving approximately 120,000 individuals in Cameroon, azithromycin 1.5% eye drops significantly reduced the prevalence of active trachoma in children aged 1-9 years, from 24.0% before treatment to 2.8% one year after three annual treatment campaigns.

The treatment was well-tolerated with no serious adverse events reported, demonstrating both safety and efficacy in controlling trachoma in a highly endemic area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of azithromycin 1.5% eye drops for mass treatment of active trachoma in a highly endemic district in Cameroon. Bella, AL., Einterz, E., Huguet, P., et al.[2022]

In a cluster-randomized trial in Ethiopia, mass treatment with azithromycin for trachoma showed a low prevalence of adverse events, ranging from 4.9% to 7.0% in children aged 1-9 and 17.0% to 18.7% in individuals aged 10 and older.

The study indicated that adverse events were generally well tolerated and tended to cluster by household or village, suggesting that mass azithromycin distributions are safe in this community setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events after mass azithromycin treatments for trachoma in Ethiopia. Ayele, B., Gebre, T., House, JI., et al.[2021]

In a study of 3,995 patients aged 2-94, azithromycin demonstrated a favorable safety profile, with only 12.0% of patients experiencing side effects, which is significantly lower than the 14.2% seen with other standard antibiotics.

The most common side effects were mild to moderate gastrointestinal issues, and only 0.7% of patients discontinued treatment due to side effects, indicating that azithromycin is well tolerated even among patients with various concurrent illnesses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical toleration and safety of azithromycin. Hopkins, S.[2022]

Azithromycin 1.5% ophthalmic solution is effective in treating purulent bacterial conjunctivitis, showing similar clinical cure rates to tobramycin 0.3% over different treatment durations in a multicenter study involving both adults and children.

In cases of trachomatous conjunctivitis, a 3-day treatment with azithromycin 1.5% was as effective as a single oral dose of azithromycin, demonstrating its efficacy and good tolerability in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Azithromycin 1.5% ophthalmic solution: in purulent bacterial or trachomatous conjunctivitis. Garnock-Jones, KP.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Active trachoma two years after three rounds of azithromycin mass treatment in Cheha District Gurage Zone, Southern Ethiopia. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of short duration azithromycin eye drops versus azithromycin single oral dose for the treatment of trachoma in children: a randomised, controlled, double-masked clinical trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Comparison of annual versus twice-yearly mass azithromycin treatment for hyperendemic trachoma in Ethiopia: a cluster-randomised trial. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Targeted Antibiotics for Trachoma: A Cluster-Randomized Trial. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of single-dose azithromycin in treatment of trachoma. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of azithromycin 1.5% eye drops for mass treatment of active trachoma in a highly endemic district in Cameroon. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Trachoma: a review. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Adverse events after mass azithromycin treatments for trachoma in Ethiopia. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Clinical toleration and safety of azithromycin. [2022]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Azithromycin 1.5% ophthalmic solution: in purulent bacterial or trachomatous conjunctivitis. [2021]