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

Phase 2

Recruiting

• Conditions: candidemia; fungal infection; 10017528

• Registration Number: NL-OMON52806
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 28

Inclusion 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.

Exclusion Criteria

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. infection which is being studied.
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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study endpoint is the time to first negative blood culture.</p><br>