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Efficacy of Interferon-gamma in Combination With Anidulafungin for the Treatment of Candidemia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2012 by Corine Delsing, Radboud University.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Corine Delsing, Radboud University Identifier:
First received: January 4, 2011
Last updated: February 13, 2012
Last verified: February 2012
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

Condition Intervention Phase
Candidemia Drug: Interferon-gamma, Recombinant Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Corine Delsing, Radboud University:

Primary Outcome Measures:
  • the time to negative blood cultures [ Time Frame: at fixed time points during follow up (at least until 8 weeks after end of treatment) ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: until 8 weeks after end of treatment ]
  • time to death [ Time Frame: Until 8 weeks after end of treatment ]
  • outcome of fungal infection [ Time Frame: Until 8 weeks after end of treatment ]
    resolution at week 2 and 8 after end of treatment, patient status at end of therapy, microbiological parameters

  • duration of antifungal therapy [ Time Frame: Until end of treatment ]
  • duration of hospitalization [ Time Frame: Until end of hospitilization ]
  • immunological parameters [ Time Frame: Until 8 weeks after end of treatment ]
  • tolerability and safety [ Time Frame: until 8 weeks after end of treatment ]

Estimated Enrollment: 20
Study Start Date: January 2011
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interferon-gamma Drug: Interferon-gamma, Recombinant
Interferon 50 mcg/m2 to be administered three times per week during two weeks
No Intervention: No intervention
No adjunctive treatment


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01270490

Contact: Corine Delsing, MD +31-24-3618819
Contact: Mihai Netea, MD. PhD +31-24-3618819

Radboud University Medical Centre Nijmegen Recruiting
Nijmegen, Netherlands, 6525 GA
Contact: Corine Delsing, MD    +31-24-3618819   
Principal Investigator: Corine Delsing, MD         
Sub-Investigator: Chantal Bleeker-Rovers, MD, PhD         
Sub-Investigator: Mihai Netea, MD, PhD         
Sub-Investigator: Bart Jan Kullberg, MD PhD         
Sponsors and Collaborators
Radboud University
Study Director: Mihai Netea, MD PhD Radboud University
Principal Investigator: Corine Delsing, MD Radboud University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Corine Delsing, Drs, Radboud University Identifier: NCT01270490     History of Changes
Other Study ID Numbers: Interferon-gamma 001
2009-014600-66 ( EudraCT Number )
NL28823.091.10 ( Other Identifier: Dutch Central Committee on Research inv. Human Subjects )
Study First Received: January 4, 2011
Last Updated: February 13, 2012

Keywords provided by Corine Delsing, Radboud University:
candida sepsis
invasive fungal disease

Additional relevant MeSH terms:
Candidiasis, Invasive
Systemic Inflammatory Response Syndrome
Pathologic Processes
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antifungal Agents processed this record on July 19, 2017