RecruitingPhase 3

Parasitic Ulcer Treatment Trial

United States, Brazil, India232 participantsStarted 2024-07-01

Plain-language summary

The Parasitic Ulcer Treatment Trial (PUTT) is a multi-center, parallel-group, randomized clinical trial. The purpose of this study is to determine whether including topical corticosteroids in a regimen for acanthamoeba keratitis (AK) will improve vision. Patients presenting to all enrollment centers with evidence of acanthamoeba keratitis will be eligible for the trial if there is evidence of ocular inflammation after 4 weeks of anti-amoebic therapy. Those who agree to participate will be randomized to one of two treatment groups: * Group 1: Topical corticosteroid * Group 2: Topical placebo

Who can participate

Age range

8 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * AK on at least one of the following: culture, smear, PCR, shotgun sequencing, biopsy, or confocal microscopy * Ocular inflammation after 1 month of anti-amoebic treatment, defined as conjunctival, corneal, episcleral, or anterior chamber inflammation Exclusion Criteria: * Evidence or history of interstitial keratitis * Known herpetic keratitis, as determined from history, exam, or microbiological testing * Known fungal keratitis, as demonstrated from corneal scrapings * Corneal perforation or impending corneal perforation * Prior therapeutic keratoplasty for acanthamoeba keratitis * Unwillingness or inability to follow-up * No light perception in the affected eye * Known hypertensive response to steroids * Corticosteroid allergy * Concurrent treatment with systemic corticosteroids * Concurrent granulomatous amoebic encephalitis

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Vision

Timeframe: 6 Months

Trial details

NCT IDNCT06213649

SponsorJeremy Keenan, MD, MPH

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-07

Contact for this trial

Jeremy Keenan, MD, MPH

415-476-6323 jeremy.keenan@ucsf.edu

View on ClinicalTrials.gov More Acanthamoeba Keratitis trials