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Recruiting

NCT Number: NCT04650607

Phage Safety Cohort Study

This cohort study aims to describe the adverse events related to the use of bacteriophages to treat serious infections, data from the literature being almost non-existent on this subject.

Recruiting

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Key information

Conditions

Prosthetic Joint Infection Infections Severe Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

All potential serious adverse events in compassionate cases will be collected, and classified as potentially related to surgery, to antibiotics, or to phages, with the help of the HCL pharmacovigilance center. In addition, biobanking of pre- and post-treatment blood specimens (bloods, serums and cells) will determine whether phage immunization is implicated in particular adverse events.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient 18 years of age or older with a serious infection treated at CRIOAc Lyon by phage therapy
  • Patient who did not object to participating in the study
  • Patients ayant un poids minimum de 46kg

Exclusion criteria

  • Patients under guardianship/curatorship
  • Patients deprived of liberty
  • Pregnant or breastfeeding women

Treatment and study plan

Adverse event after injection of phages

Other

rate and description of adverse event after injection of phages

Primary outcomes

  1. type of adverse event

    Time frame: 12 months after the injection of phages

    description of the adverse event

  2. rate of adverse event

    Time frame: 12 months after the injection of phages

    proportion of patient having an avderse event after injection of phages

Secondary outcomes

  1. biobanking PHA SA CO

    Time frame: from before the injection of phages to 6 months after the injection of phages

    to assess the role of immunization induced by phage phages in the occurrence of adverse

  2. biobanking PhageRESPONSE

    Time frame: from before the injection of phages to 6 months after the injection of phages

    Characterize the cellular and humoral immune response in patients with a severe bacterial infection requiring treatment compassionate by bacteriophage

Study contacts

Contact information is provided by the study sponsor or research team.

Johanna Boulant, CRA

CONTACT

[email protected]

04 26 73 29 38

Tristan Ferry, Md,PhD

CONTACT

[email protected]

04 26 73 29 38

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: PHA-SA-CO

Important dates

Study start
2022
Primary completion
2023
Study completion
2028
First posted
Dec 2, 2020
Registry last updated
Apr 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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