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

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ClinicalTrials.gov Identifier: NCT01270490
Recruitment Status : Unknown
Verified February 2012 by Corine Delsing, Radboud University.
Recruitment status was:  Recruiting
First Posted : January 5, 2011
Last Update Posted : February 14, 2012
Information provided by (Responsible Party):
Corine Delsing, Radboud University

Brief 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

Condition or disease Intervention/treatment Phase
Candidemia Drug: Interferon-gamma, Recombinant Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2011
Estimated Primary Completion Date : January 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. overall survival [ Time Frame: until 8 weeks after end of treatment ]
  2. time to death [ Time Frame: Until 8 weeks after end of treatment ]
  3. 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

  4. duration of antifungal therapy [ Time Frame: Until end of treatment ]
  5. duration of hospitalization [ Time Frame: Until end of hospitilization ]
  6. immunological parameters [ Time Frame: Until 8 weeks after end of treatment ]
  7. tolerability and safety [ Time Frame: until 8 weeks after end of treatment ]

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01270490

Contact: Corine Delsing, MD +31-24-3618819 C.Delsing@AIG.umcn.nl
Contact: Mihai Netea, MD. PhD +31-24-3618819 M.Netea@AIG.umcn.nl

Radboud University Medical Centre Nijmegen Recruiting
Nijmegen, Netherlands, 6525 GA
Contact: Corine Delsing, MD    +31-24-3618819    C.Delsing@aig.umcn.nl   
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Corine Delsing, Drs, Radboud University
ClinicalTrials.gov 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 )
First Posted: January 5, 2011    Key Record Dates
Last Update Posted: February 14, 2012
Last Verified: February 2012

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

Additional relevant MeSH terms:
Candidiasis, Invasive
Invasive Fungal Infections
Systemic Inflammatory Response Syndrome
Pathologic Processes
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antifungal Agents