RECRUITING

Safety and Efficacy of Interferon-Gamma 1b in Patients with Candidemia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2022-03-31

Study Completion:2027-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04979052

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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.	* Subjects with a history of allergy or intolerance to rIFN-γ,or any other IMP ingredient or with a history of immediate type hypersensitivity to latex/rubber. * Subjects with a history of documented epileptic seizures. * Subjects with severe liver failure ((\>5x upper limit AST or ALT or impaired synthesis of proteins such as coagulation factors manifested by increased prothrombin time). * Treatment with heterologous serum proteins, or immunological preparations such as vaccines, toxins, serums and allergens within three days before trial enrolment. * Women who are pregnant or lactating. * Subjects who are unlikely to survive more than 24 hours. * Subjects who have failed previous systemic antifungal therapy for the Candida spp. * Subjects who have received more than 120 hours of systemic antifungal therapy for the current episode, within 120 hours prior to study entry. * With respect to incapacitated subjects: * Any patient that is deemed incapable of personally providing informed consent due to a neurodegenerative disease, genetic syndrome, and/or perinatal asphyxia, will not be eligible for inclusion in this trial. * Any incapacitated subject that is not expected to recover to a point where they will personally be able to provide informed consent will not be eligible for inclusion in this trial. Patients with renal failure or dialysis do not have a contraindication for treatment with rIFN-y and can be included in this study

Inclusion Criteria

Exclusion Criteria

* 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.

* Subjects with a history of allergy or intolerance to rIFN-γ,or any other IMP ingredient or with a history of immediate type hypersensitivity to latex/rubber.
* Subjects with a history of documented epileptic seizures.
* Subjects with severe liver failure ((\>5x upper limit AST or ALT or impaired synthesis of proteins such as coagulation factors manifested by increased prothrombin time).
* Treatment with heterologous serum proteins, or immunological preparations such as vaccines, toxins, serums and allergens within three days before trial enrolment.
* Women who are pregnant or lactating.
* Subjects who are unlikely to survive more than 24 hours.
* Subjects who have failed previous systemic antifungal therapy for the Candida spp.
* Subjects who have received more than 120 hours of systemic antifungal therapy for the current episode, within 120 hours prior to study entry.
* With respect to incapacitated subjects:
* Any patient that is deemed incapable of personally providing informed consent due to a neurodegenerative disease, genetic syndrome, and/or perinatal asphyxia, will not be eligible for inclusion in this trial.
* Any incapacitated subject that is not expected to recover to a point where they will personally be able to provide informed consent will not be eligible for inclusion in this trial. Patients with renal failure or dialysis do not have a contraindication for treatment with rIFN-y and can be included in this study

Contacts and Locations

Study Contact

Frank vd Veerdonk, Dr.

CONTACT

0031243618819

frank.vandeveerdonk@radboudumc.nl

Principal Investigator

Frank vd Veerdonk, Dr.

PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Study Locations (Sites)

Duke University

Durham, North Carolina, 27708

United States

Collaborators and Investigators

Sponsor: Radboud University Medical Center

Frank vd Veerdonk, Dr., PRINCIPAL_INVESTIGATOR, Radboud University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-31

Study Completion Date2027-06

Study Record Updates

Study Start Date2022-03-31

Study Completion Date2027-06

Terms related to this study

Keywords Provided by Researchers

Interferon Gamma 1b

Additional Relevant MeSH Terms

Candidemia