RECRUITING

Parasitic Ulcer Treatment Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Parasitic Ulcer Treatment Trial

Quick Facts

Study Start:2024-07-01
Study Completion:2028-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06213649

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:8 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * AK on at least one of the following: culture, smear, PCR, shotgun sequencing, biopsy, or confocal microscopy
  2. * Ocular inflammation after 1 month of anti-amoebic treatment, defined as conjunctival, corneal, episcleral, or anterior chamber inflammation
  1. * Evidence or history of interstitial keratitis
  2. * Known herpetic keratitis, as determined from history, exam, or microbiological testing
  3. * Known fungal keratitis, as demonstrated from corneal scrapings
  4. * Corneal perforation or impending corneal perforation
  5. * Prior therapeutic keratoplasty for acanthamoeba keratitis
  6. * Unwillingness or inability to follow-up
  7. * No light perception in the affected eye
  8. * Known hypertensive response to steroids
  9. * Corticosteroid allergy
  10. * Concurrent treatment with systemic corticosteroids
  11. * Concurrent granulomatous amoebic encephalitis

Contacts and Locations

Study Contact

Jeremy Keenan, MD, MPH
CONTACT
415-476-6323
jeremy.keenan@ucsf.edu
Gerami Seitzman, MD
CONTACT
415-476-1442
gerami.seitzman@ucsf.edu

Principal Investigator

Jeremy Keenan, MD, MPH
PRINCIPAL_INVESTIGATOR
Proctor Foundation, UCSF

Study Locations (Sites)

University of California, Los Angeles
Los Angeles, California, 90095
United States
University of California, San Francisco
San Francisco, California, 94158
United States
University of Florida
Gainesville, Florida, 32605
United States
University of Miami
Miami, Florida, 33136
United States
University of Illinois, Chicago
Chicago, Illinois, 60612
United States
University of Iowa
Iowa City, Iowa, 52242
United States
Johns Hopkins University
Baltimore, Maryland, 21287
United States
Columbia University
New York, New York, 10032
United States
Oregon Health and Science University
Portland, Oregon, 97239
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Jeremy Keenan, MD, MPH

  • Jeremy Keenan, MD, MPH, PRINCIPAL_INVESTIGATOR, Proctor Foundation, UCSF

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-01
Study Completion Date2028-07

Study Record Updates

Study Start Date2024-07-01
Study Completion Date2028-07

Terms related to this study

Keywords Provided by Researchers

  • corneal ulcer
  • steroids

Additional Relevant MeSH Terms

  • Acanthamoeba Keratitis