Forsøg med behandling af parasitære mavesår (PUTT)
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 3
Kontakter og lokationer
Studiekontakt
- Navn: Jeremy Keenan, MD, MPH
- Telefonnummer: 415-476-6323
- E-mail: jeremy.keenan@ucsf.edu
Undersøgelse Kontakt Backup
- Navn: Krisi Aromin
- E-mail: krisianne.aromin@ucsf.edu
Studiesteder
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São Paulo, Brasilien
- Rekruttering
- Federal University of São Paulo
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Kontakt:
- Denise de Freitas
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London, Det Forenede Kongerige
- Rekruttering
- Moorfields Eye Hospital
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Kontakt:
- Su-yin Koay
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California
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Irvine, California, Forenede Stater, 92617
- Rekruttering
- University of California Irvine
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Kontakt:
- Olivia Lee
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Los Angeles, California, Forenede Stater, 90095
- Ikke rekrutterer endnu
- University of California Los Angeles
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Kontakt:
- Anthony Aldave
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San Francisco, California, Forenede Stater, 94158
- Rekruttering
- University of California, San Francisco
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Underforsker:
- Gerami Seitzman, MD
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Ledende efterforsker:
- Jeremy Keenan, MD, MPH
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Kontakt:
- Krisianne Aromin
- E-mail: krisianne.aromin@ucsf.edu
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
- Rekruttering
- University of Colorado Anschutz
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Kontakt:
- Travis Redd
- Telefonnummer: 7208482020
- E-mail: travis.redd@cuanschutz.edu
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Florida
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Gainesville, Florida, Forenede Stater, 32605
- Rekruttering
- University of Florida
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Kontakt:
- Sonal Tuli
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Miami, Florida, Forenede Stater, 33136
- Rekruttering
- University of Miami
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Kontakt:
- Guillermo Amescua
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Orlando, Florida, Forenede Stater, 33612
- Rekruttering
- University of South Florida
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Kontakt:
- Edgar Espana
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Illinois
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Chicago, Illinois, Forenede Stater, 60612
- Rekruttering
- University of Illinois, Chicago
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Kontakt:
- Elmer Tu
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Iowa
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Iowa City, Iowa, Forenede Stater, 52242
- Rekruttering
- University of Iowa
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Kontakt:
- Mark Greiner
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Maryland
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Baltimore, Maryland, Forenede Stater, 21287
- Rekruttering
- Johns Hopkins University
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Kontakt:
- Nakul Shekhawat
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New York
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New York, New York, Forenede Stater, 10032
- Rekruttering
- Columbia University
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Kontakt:
- Leejee Suh
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New York, New York, Forenede Stater, 10003
- Rekruttering
- New York Eye and Ear Infirmary
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Kontakt:
- Sumayya Ahmad
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Oregon
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Portland, Oregon, Forenede Stater, 97210
- Rekruttering
- Devers Eye Institute
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Kontakt:
- Ashlin Joye
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Portland, Oregon, Forenede Stater, 97239
- Afsluttet
- Oregon Health and Science University
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- Rekruttering
- University of Pennsylvania
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Kontakt:
- Bennie Jeng
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Pittsburgh, Pennsylvania, Forenede Stater, 15219
- Rekruttering
- University of Pittsburgh Medical Center
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Kontakt:
- Gaurav Prakash, MD
- Telefonnummer: 412-647-2200
- E-mail: prakashg@upmc.edu
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Texas
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Houston, Texas, Forenede Stater, 77030
- Rekruttering
- Baylor College of Medicine
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Kontakt:
- Alejandro Arboleda, MD MS
- Telefonnummer: 713-798-5143
- E-mail: alejandro.arboleda@bcm.edu
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Washington
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Seattle, Washington, Forenede Stater, 98104
- Rekruttering
- University of Washington
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Kontakt:
- Minh Nguyen, MD
- Telefonnummer: 206-543-7250
- E-mail: minhng88@uw.edu
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Tamil Nadu
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Coimbatore, Tamil Nadu, Indien
- Rekruttering
- Aravind Eye Hospital
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Kontakt:
- Revathi Rajamaran
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Madurai, Tamil Nadu, Indien
- Rekruttering
- Aravind Eye Hospital
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Kontakt:
- NV Prajna
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Topical steroids
Participants in this arm will receive anti-amoebic therapy plus topical steroids. |
PHMB is a cationic antiseptic agent used for topical treatment of acanthamoeba keratitis (AK). Both treatment groups will take PHMB at least 4 times daily while on the allocated study drug.
Andre navne:
Dexamethasone sodium phosphate, 0.1% ophthalmic solution will be administered 4 times daily for 4 weeks, then 2 times daily for 2 weeks, then 1 time daily for 2 weeks. |
|
Placebo komparator: Topical placebo
Participants in this arm will receive anti-amoebic therapy plus topical placebo. |
PHMB is a cationic antiseptic agent used for topical treatment of acanthamoeba keratitis (AK). Both treatment groups will take PHMB at least 4 times daily while on the allocated study drug.
Andre navne:
An artificial tear ophthalmic solution will be administered 4 times daily for 4 weeks, then 2 times daily for 2 weeks, then 1 time daily for 2 weeks. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Vision
Tidsramme: 6 Months
|
Best corrected visual acuity |
6 Months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Self-reported eye pain
Tidsramme: 2 months
|
Pain scale (Likert 11-point ordinal scale from 0 to 10; 0=no pain, 10=worst pain) |
2 months
|
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Clinical Resolution
Tidsramme: 12 months
|
Time until clinical resolution (i.e., healed ocular surface and absence of inflammation) |
12 months
|
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Multivariate Analysis
Tidsramme: 6 Months
|
The multivariate analysis will include the following outcomes measured at 6 months: best corrected visual acuity, corneal thinning on optical coherence tomography (OCT), scar density on Scheimpflug imaging, irregular astigmatism, glare, microbial clearance on confocal microscopy, pain score, time until clinical resolution |
6 Months
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Jeremy Keenan, MD, MPH, Proctor Foundation, UCSF
- Ledende efterforsker: Gerami Seitzman, MD, Proctor Foundation, UCSF
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 23-39559
- UG1EY033284 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD available on request.
IPD-delingstidsramme
After publication of the main results
IPD-delingsadgangskriterier
Request by email addressed to principal investigator.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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