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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 survival

time 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

Page last updated: August 20, 2015

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