Review of patients with Acanthamoeba keratitis treated with polihexanide
Retrospective Chart Review of Patients With Acanthamoeba Keratitis Who Have Received 0.8 mg/ml Polihexanide as Part of a Compassionate Use Program: A Non-interventional Study With Secondary Use of Data
This study looks at how well a treatment called polihexanide works for people with Acanthamoeba keratitis, a serious eye infection, by reviewing their medical records after they received the treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 14 Years and up |
| Sex | All |
| Sponsor | SIFI SpA Industry-sponsored |
| Locations | 10 sites (Brescia and 9 other locations) |
| Trial ID | NCT06641882 on ClinicalTrials.gov |
What this trial studies
This observational study involves a retrospective chart review of patients diagnosed with Acanthamoeba keratitis (AK) who received treatment with 0.8 mg/ml polihexanide as part of a compassionate use program. The study will collect patient-level data from medical charts at participating sites, focusing on clinical outcomes at least 30 days post-treatment. The aim is to assess the efficacy and safety of polihexanide in treating this rare and severe ocular infection, which currently lacks an approved pharmacological treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals over 14 years old diagnosed with Acanthamoeba keratitis who have received treatment with polihexanide.
Not a fit: Patients who do not have a confirmed diagnosis of Acanthamoeba keratitis or who have not received the specified treatment will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into a potential first-line treatment for Acanthamoeba keratitis, improving patient outcomes.
How similar studies have performed: While there are limited studies on the use of polihexanide for AK, this approach is novel as it aims to evaluate a specific treatment that has not yet been approved for this condition.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>14 years. * Clinical signs and symptoms consistent with AK. * Identification of Acanthamoeba (diagnostic confirmation of AK) by at least one of the allowed techniques as: * Confocal Microscopy * PCR, * Identification by microbiological culture or cytological smear. * Accept to sign the informed consent. Additional inclusion criteria: * Inclusion in the compassionate use program from 1st December 2022 to 31st December 2023 (date of approval by the local Ethics Committee). * Treatment with 0.8 mg/ml polihexanide. * End of treatment with 0.8 mg/ml polihexanide. * Medical chart available at clinical site. Exclusion Criteria: None
Where this trial is running
Brescia and 9 other locations
- ASST Spedali Civili — Brescia, Italy (Recruiting)
- SOD Oculistica Azienda Ospedaliero Universitaria Careggi — Florence, Italy (Recruiting)
- Policlinico G.Martino — Messina, Italy (Recruiting)
- IRCCS Ospedale San Raffaele — Milano, Italy (Recruiting)
- ASST Fatebenefratelli Sacco — Milano, Italy (Recruiting)
- Policlinico S. Matteo — Pavia, Italy (Recruiting)
- Policlinico TorVergata — Rome, Italy (Recruiting)
- Policlinico Universitario Campus Biomedico — Rome, Italy (Recruiting)
- AZIENDA ULSS 3 Serenissima-UOC Oculistica — Venice, Italy (Recruiting)
- Azienda Ospedaliera Universitaria Verona — Verona, Italy (Recruiting)
Study contacts
- Principal investigator: Karl Knutsson, MD — San Raffaele Scientific Institute
- Study coordinator: Claudine Civiale
- Email: claudine.civiale@sifigroup.com
- Phone: +39 0957922111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.