Standardised Treatment And Monitoring Protocol to assess safety and tolerability of phage therapy in adults and children (STAMP study)

Not Applicable

Recruiting

• Conditions: Bacterial infections; Infection - Other infectious diseases

• Registration Number: ACTRN12621001526864
• Lead Sponsor: Western Sydney Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-10
• Last Update Posted: 13 June 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1) Patient for whom at least two suitably qualified clinical specialists have agreed phage therapy should be used
2) A suitable phage(s) product is available that complies with all relevant regulatory requirements for therapeutic administration

Exclusion Criteria

Participant, parent or guardian or person responsible has not provided informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and tolerability: assessed through adverse events (AEs), vital signs, and clinical laboratory assessments. Safety will be defined by the absence of serious adverse events (SAEs) attributable to study material (phage) occurring from day 1 (first dose of phage administered) until 2 weeks after completion of therapy. The Medical Dictionary for Regulatory Activities (MedDRA) will be used to code all AEs, which will also be assessed for seriousness, relatedness (to phage therapy and the intervention protocol) and severity.[2 weeks after completion of therapy]