Evaluation of safety and effectiveness of a nebulised phage cocktail in patients with chronic rhinosinusitis (CRS)

Phase 1

Recruiting

• Conditions: chronic rhinosinusitis; Infection - Studies of infection and infectious agents; Inflammatory and Immune System - Other inflammatory or immune system disorders; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12623000542695
• Lead Sponsor: Central Adelaide Local Health Network

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-22
• Last Update Posted: 21 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

•Participants must have had at least two of the following symptoms of chronic rhinosinusitis (nasal discharge, postnasal drip, nasal obstruction, facial pain and pressure or lack of sense of smell) that has been previously persistent for greater than 3 months.
•Participants must have had at least one operation for their chronic rhinosinusitis but should be at least 3 months post-operative.
•Participants must present with signs and symptoms of acute infectious exacerbation of S. aureus or MRSA CRS with positive microbial cultures,
•Participants must be sensitive to clinical grade S. aureus bacteriophage and to antibiotics. A nasal swab will be collected from the patient prior to recruitment and sensitivity to the bacteriophage cocktail and to antibiotics will be determined via testing of the patient’s clinical isolate.
•Participants must show evidence of chronic sinusitis by direct endoscopic examination.
•Participants must have the ability to administer twice daily sinus nebulisations for the duration of the treatment period.
•Participants (male or female) must be over 18 years. No upper age limit, at discretion of treating doctor.
•Participants must be able to give written informed consent.
•Participants must have the ability and willingness to attend several visits to the study centre.
•Participants must have the willingness and ability to comply with the requirements of the protocol as determined by the Investigator.
•Females of childbearing potential must have a negative pregnancy test prior to enrolment and will be advised through the Informed Consent process to avoid becoming pregnant over the duration of the study, and must assert that they will employ an effective form of birth control for the duration of the study.

Exclusion Criteria

•Participants must not have a sinonasal swab that is positive for Pseudomonas aeruginosa
•Participants must not have Graft-versus-host disease (GVHD) or be on immunosuppressive therapy
•Participants who are unlikely to comply with the study protocol or, in the opinion of the investigator, would not be a suitable candidate for participation in the study.
•Females must not be breastfeeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified