A multicentre, prospective, randomized open-label pilot study to assess the feasibility and preliminary efficacy of interferon gamma in combination with Anidulafungin for the treatment of candidemia

Phase 1

• Conditions: Candida bloodstream infections/ candidemia; MedDRA version: 12.1Level: LLTClassification code 10042938Term: Systemic candida; MedDRA version: 12.1Level: LLTClassification code 10042939Term: Systemic candidiasis; MedDRA version: 12.1Level: LLTClassification code 10049160Term: Candidaemia; MedDRA version: 12.1Level: PTClassification code 10053166Term: Candida sepsis; MedDRA version: 12.1Level: LLTClassification code 10060573Term: Candidemia; MedDRA version: 12.1Level: LLTClassification code 10013431Term: Disseminated candidiasis; MedDRA version: 12.1Level: LLTClassification code 10052240Term: Septicaemia candida; MedDRA version: 12.1Level: LLTClassification code 10054610Term: Septicemia candida

• Registration Number: EUCTR2009-014600-66-NL
• Lead Sponsor: niversity Medical Center Nijmegen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-05-24
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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 old of age or older
•Subjects with at least one positive blood culture isolation of Candida species from a specimen drawn within 96 hours prior to study entry.
•Subjects who have clinical evidence of infection AT SOME TIME WITHIN 96 HOURS PRIOR TO ENROLLMENT, including AT LEAST ONE of the following:
-Temperature >37.8 °C on 2 occasions at least 4 hours apart or one determination measurement > 38.2 °C
-Systolic blood pressure < 90 or a > 30 mmHg decrease in systolic BP from the subject’s normal baseline.
-Signs of inflammation (swelling, heat, erythema, purulent drainage) from a site infected with Candida (eg, joint, skin, eye, bone, esophagus)
-Radiologic findings of invasive canidiasis
•Subject or their legal representative must sign a written informed consent form.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Subjects with a history of allergy or intolerance to echinocandines or IFNgamma
•Subjects with an absolute neutrophil count of less than 500/mm3 at study entry
•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 48 hours of systemic antifungal therapy for the current episode, within 96 hours prior to study entry.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the (preliminary) efficacy of interferon gamma as adjunctive treatment in combination with standard therapy for the treatment of patients with candidemia by assessment of a series of exploratory parameters. The primary endpoint is to compare the time to negative blood cultures.;Secondary Objective: Secondary endpoints are the overall survival, time to death, outcome of fungal infection (resolution at week 2 and 8 after end of treatment, patient status at end of therapy, microbiological parameters) duration of antifungal therapy, duration of hospitalization and immunological parameters. A secondary aim will be to evaluate host response markers that could be used to identify patients with immunoparalysis who will benefit from immunotherapy, and to monitor the patient’s immunological response to IFN-gamma. ;Primary end point(s): The primary endpoint is the time to negative blood cultures.