Safety and Efficacy of Recombinant Interferon-Gamma 1b (rIFN-Gamma 1b) Given With Standard Therapy in Patients With Candidemia

Who is this study for? Patients with Candidemia
What treatments are being studied? Interferon Gamma-1B
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

A multi-center open label adaptive randomized interventional phase 2 study to evaluate safety and efficacy of rIFN-y treatment in patiens with candidemia.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Males or non-pregnant females (who must agree to use barrier methods of contraception during the study therapy period, women of childbearing age must have a negative urine pregnancy or serum test at baseline).

• Subjects who are 18 years of age or older.

• Subjects with at least one positive blood culture isolation of Candida species from a specimen drawn within 120 hours prior to study entry.

• Subjects who have clinical evidence of infection sometime within 120 hours prior to enrolment, including at least one of the following:

‣ Temperature \>37.8 ˚C on two occasions at least four hours apart or one measurement \> 38.2 ˚C

⁃ Systolic blood pressure \<90 or a \>30 mmHg decrease in systolic blood pressure from the subject's normal baseline or the need for vassopressive therapy.

⁃ Signs of inflammation (swelling, heat, erythema, purulent drainage) from a site infected with Candida (e.g. joint, skin, eye, bone, oesophagus).

⁃ Radiologic findings of invasive candidiasis.

• Subject or their legal representative must sign a written informed consent form.

• In case a patient eligible to participate in this study is incapacitated and as such unable to personally provide informed consent, a written consent form must be signed by their legal representative.

‣ Only incapacitated patients that can be expected to regain the capability to consent will be included in this study. In this case, informed consent will be discussed personally with the study participant after recovery.

⁃ The inclusion of incapacitated subjects will only be performed under the above conditions in a country in which such an approach is legal and deemed ethically acceptable.

Locations
United States
North Carolina
Duke University
RECRUITING
Durham
Other Locations
Germany
Klinikum Der Johann Wolfgang Von Goethe Universitaet
RECRUITING
Frankfurt Am Main
Greece
Hellenic Institute for the Study of Sepsis (HISS)
RECRUITING
Athens
Netherlands
Radboudumc
RECRUITING
Nijmegen
Romania
Universitatea de Medicina si Farmacie luliu Hatieganu
RECRUITING
Cluj-napoca
Switzerland
Centre Hospitalier Universitaire Vaudois
RECRUITING
Lausanne
Contact Information
Primary
Frank vd Veerdonk, Dr.
frank.vandeveerdonk@radboudumc.nl
0031243618819
Time Frame
Start Date: 2022-03-31
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 200
Treatments
Active_comparator: Interferon-Gamma
Recombinant Interferon-Gamma 1b combined with standard therapy
No_intervention: Standard of care
Standard of care antifungal therapy according tot ESCMID/EFISG (Europe) or ISDA (US) guidelines.
Related Therapeutic Areas
Sponsors
Leads: Radboud University Medical Center
Collaborators: Horizon 2020 - European Commission

This content was sourced from clinicaltrials.gov