Forsøk på behandling av parasittiske sår (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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 3
Kontakter og plasseringer
Studiekontakt
- Navn: Jeremy Keenan, MD, MPH
- Telefonnummer: 415-476-6323
- E-post: jeremy.keenan@ucsf.edu
Studer Kontakt Backup
- Navn: Krisi Aromin
- E-post: krisianne.aromin@ucsf.edu
Studiesteder
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São Paulo, Brasil
- Rekruttering
- Federal University of São Paulo
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Ta kontakt med:
- Denise de Freitas
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California
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Irvine, California, Forente stater, 92617
- Rekruttering
- University of California Irvine
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Ta kontakt med:
- Olivia Lee
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Los Angeles, California, Forente stater, 90095
- Har ikke rekruttert ennå
- University of California Los Angeles
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Ta kontakt med:
- Anthony Aldave
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San Francisco, California, Forente stater, 94158
- Rekruttering
- University of California, San Francisco
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Underetterforsker:
- Gerami Seitzman, MD
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Hovedetterforsker:
- Jeremy Keenan, MD, MPH
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Ta kontakt med:
- Krisianne Aromin
- E-post: krisianne.aromin@ucsf.edu
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Colorado
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Aurora, Colorado, Forente stater, 80045
- Rekruttering
- University of Colorado Anschutz
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Ta kontakt med:
- Travis Redd
- Telefonnummer: 7208482020
- E-post: travis.redd@cuanschutz.edu
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Florida
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Gainesville, Florida, Forente stater, 32605
- Rekruttering
- University of Florida
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Ta kontakt med:
- Sonal Tuli
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Miami, Florida, Forente stater, 33136
- Rekruttering
- University of Miami
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Ta kontakt med:
- Guillermo Amescua
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Orlando, Florida, Forente stater, 33612
- Rekruttering
- University of South Florida
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Ta kontakt med:
- Edgar Espana
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Illinois
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Chicago, Illinois, Forente stater, 60612
- Rekruttering
- University of Illinois, Chicago
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Ta kontakt med:
- Elmer Tu
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Iowa
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Iowa City, Iowa, Forente stater, 52242
- Rekruttering
- University of Iowa
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Ta kontakt med:
- Mark Greiner
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Maryland
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Baltimore, Maryland, Forente stater, 21287
- Rekruttering
- Johns Hopkins University
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Ta kontakt med:
- Nakul Shekhawat
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New York
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New York, New York, Forente stater, 10032
- Rekruttering
- Columbia University
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Ta kontakt med:
- Leejee Suh
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New York, New York, Forente stater, 10003
- Rekruttering
- New York Eye and Ear Infirmary
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Ta kontakt med:
- Sumayya Ahmad
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Oregon
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Portland, Oregon, Forente stater, 97210
- Rekruttering
- Devers Eye Institute
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Ta kontakt med:
- Ashlin Joye
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Portland, Oregon, Forente stater, 97239
- Avsluttet
- Oregon Health and Science University
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19104
- Rekruttering
- University of Pennsylvania
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Ta kontakt med:
- Bennie Jeng
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Pittsburgh, Pennsylvania, Forente stater, 15219
- Rekruttering
- University of Pittsburgh Medical Center
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Ta kontakt med:
- Gaurav Prakash, MD
- Telefonnummer: 412-647-2200
- E-post: prakashg@upmc.edu
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Texas
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Houston, Texas, Forente stater, 77030
- Rekruttering
- Baylor College of Medicine
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Ta kontakt med:
- Alejandro Arboleda, MD MS
- Telefonnummer: 713-798-5143
- E-post: alejandro.arboleda@bcm.edu
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Washington
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Seattle, Washington, Forente stater, 98104
- Rekruttering
- University of Washington
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Ta kontakt med:
- Minh Nguyen, MD
- Telefonnummer: 206-543-7250
- E-post: minhng88@uw.edu
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Tamil Nadu
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Coimbatore, Tamil Nadu, India
- Rekruttering
- Aravind Eye Hospital
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Ta kontakt med:
- Revathi Rajamaran
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Madurai, Tamil Nadu, India
- Rekruttering
- Aravind Eye Hospital
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Ta kontakt med:
- NV Prajna
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London, Storbritannia
- Rekruttering
- Moorfields Eye Hospital
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Ta kontakt med:
- Su-yin Koay
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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 navn:
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 navn:
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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Vision
Tidsramme: 6 Months
|
Best corrected visual acuity |
6 Months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
|
|
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
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Jeremy Keenan, MD, MPH, Proctor Foundation, UCSF
- Hovedetterforsker: Gerami Seitzman, MD, Proctor Foundation, UCSF
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 23-39559
- UG1EY033284 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD available on request.
IPD-delingstidsramme
After publication of the main results
Tilgangskriterier for IPD-deling
Request by email addressed to principal investigator.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
Legemiddel- og utstyrsinformasjon, studiedokumenter
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