Bacteriophage Therapy of Difficult-to-treat Infections

NCT05498363 | Completed

• 1 other identifier: BT100
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

A retrospective, observational analysis of the first one hundred consecutive cases of bacteriophage therapy of difficult-to-treat infections, facilitated by a Belgian consortium.

Conditions

Bacterial Infections

Keywords

Bacterial infections; Bacteriophages; Antibiotic resistance; Observational study; Retrospective analysis; Difficult to treat infections

Outcome Measures

Primary Outcomes (3)

• Clinical improvement

  Clinical improvement of at least one symptom associated with the original bacterial infection, as assessed by the treating physician

  One week to one year after treatment, depending on the infection type

• Microbial eradication

  The absence of the original causative agent of the bacterial infection in culture

  One week to one year after treatment, depending on the infection type

• Adverse reactions

  Duration and severity of adverse reactions, as assessed by the treating physician

  One week to one year after treatment, depending on the infection type

Interventions

Bacteriophage therapy BIOLOGICAL

Difficult-to-treat bacterial infections were treated with bacteriophages (selected from a collection of 25 individual bacteriophages and 6 bacteriophage cocktails), which were shown to target the patient's infecting bacterial strain (in vitro)

Eligibility Criteria

• Age: 1 Month - 91 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with difficult-to-treat bacterial infections for which bacteriophage therapy was requested by the treating physician, and considered to be feasible and potentially beneficial by the Phage Therapy Coordination Center (PTCC) of the Queen Astrid military hospital (QAMH)

You may qualify if:

• Patients with difficult-to-treat bacterial infections

You may not qualify if:

• None

Sponsors & Collaborators

• Queen Astrid Military Hospital: lead

Related Publications (1)

• Pirnay JP, Djebara S, Steurs G, Griselain J, Cochez C, De Soir S, Glonti T, Spiessens A, Vanden Berghe E, Green S, Wagemans J, Lood C, Schrevens E, Chanishvili N, Kutateladze M, de Jode M, Ceyssens PJ, Draye JP, Verbeken G, De Vos D, Rose T, Onsea J, Van Nieuwenhuyse B; Bacteriophage Therapy Providers; Bacteriophage Donors; Soentjens P, Lavigne R, Merabishvili M. Personalized bacteriophage therapy outcomes for 100 consecutive cases: a multicentre, multinational, retrospective observational study. Nat Microbiol. 2024 Jun;9(6):1434-1453. doi: 10.1038/s41564-024-01705-x. Epub 2024 Jun 4.

  PMID: 38834776 DERIVED

MeSH Terms

Conditions

Bacterial Infections

Interventions

Phage Therapy

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Sarah Djebara, MD

  Queen Astrid Military Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Internal Medicine and Infectious Diseases Physician

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 12, 2022
• Study Start: January 1, 2008
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: August 12, 2022

Record last verified: 2022-08