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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Radboud University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Biomerieux
Information provided by (Responsible Party):
Corine Delsing, Radboud University
ClinicalTrials.gov Identifier:
NCT01270490
First received: January 4, 2011
Last updated: February 13, 2012
Last verified: February 2012
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: until 8 weeks after end of treatment ] [ Designated as safety issue: No ]
  • time to death [ Time Frame: Until 8 weeks after end of treatment ] [ Designated as safety issue: No ]
  • outcome of fungal infection [ Time Frame: Until 8 weeks after end of treatment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • duration of hospitalization [ Time Frame: Until end of hospitilization ] [ Designated as safety issue: No ]
  • immunological parameters [ Time Frame: Until 8 weeks after end of treatment ] [ Designated as safety issue: No ]
  • tolerability and safety [ Time Frame: until 8 weeks after end of treatment ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT01270490

Contacts
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

Locations
Netherlands
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
Biomerieux
Investigators
Study Director: Mihai Netea, MD PhD Radboud University
Principal Investigator: Corine Delsing, MD Radboud University
  More Information

No publications provided by Radboud University

Additional 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, NL28823.091.10
Study First Received: January 4, 2011
Last Updated: February 13, 2012
Health Authority: Netherlands: Ministry of Health, Welfare and Sport

Keywords provided by Radboud University:
candidemia
candida sepsis
invasive fungal disease

Additional relevant MeSH terms:
Candidemia
Fungemia
Sepsis
Infection
Candidiasis, Invasive
Candidiasis
Mycoses
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Interferon-gamma
Interferons
Anidulafungin
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents
Antifungal Agents

ClinicalTrials.gov processed this record on August 28, 2014