Efficacy of Interferon-gamma in Combination With Anidulafungin for the Treatment of Candidemia
Information source: Radboud University
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Candidemia
Intervention: Interferon-gamma, Recombinant (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Radboud University Official(s) and/or principal investigator(s): Mihai Netea, MD PhD, Study Director, Affiliation: Radboud University Corine Delsing, MD, Principal Investigator, Affiliation: Radboud University
Overall contact: Corine Delsing, MD, Phone: +31-24-3618819, Email: C.Delsing@AIG.umcn.nl
Summary
The purpose of this study is to assess the feasibility and preliminary efficacy of
interferon-gamma in combination with anidulafungin for the treatment of candidemia
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: the time to negative blood cultures
Secondary outcome: overall survivaltime to death outcome of fungal infection duration of antifungal therapy duration of hospitalization immunological parameters tolerability and safety
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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 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 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 candidiasis
- Subject or their legal representative must sign a written informed consent form.
Exclusion Criteria:
- Subjects with a history of allergy or intolerance to echinocandins or IFNgamma
- Subjects with a history of documented epileptic seizures
- Subjects with severe renal impairment (creatinine clearance less than 30/mL/min)
- Subjects with severe liver failure (impaired synthesis of proteins such as
coagulation factors manifested by increased prothrombin time)
- 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
Locations and Contacts
Corine Delsing, MD, Phone: +31-24-3618819, Email: C.Delsing@AIG.umcn.nl
Radboud University Medical Centre Nijmegen, Nijmegen 6525 GA, Netherlands; Recruiting Corine Delsing, MD, Phone: +31-24-3618819, Email: C.Delsing@aig.umcn.nl Corine Delsing, MD, Principal Investigator Chantal Bleeker-Rovers, MD, PhD, Sub-Investigator Mihai Netea, MD, PhD, Sub-Investigator Bart Jan Kullberg, MD PhD, Sub-Investigator
Additional Information
Starting date: January 2011
Last updated: February 13, 2012
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