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

Primary Purpose

Candidemia

Status
Unknown status
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
Interferon-gamma, Recombinant
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Candidemia focused on measuring candidemia, candida sepsis, invasive fungal disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Radboud University Medical Centre NijmegenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Interferon-gamma

No intervention

Arm Description

No adjunctive treatment

Outcomes

Primary Outcome Measures

the time to negative blood cultures

Secondary Outcome Measures

overall survival
time to death
outcome of fungal infection
resolution at week 2 and 8 after end of treatment, patient status at end of therapy, microbiological parameters
duration of antifungal therapy
duration of hospitalization
immunological parameters
tolerability and safety

Full Information

First Posted
January 4, 2011
Last Updated
February 13, 2012
Sponsor
Radboud University Medical Center
Collaborators
BioMérieux
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1. Study Identification

Unique Protocol Identification Number
NCT01270490
Brief Title
Efficacy of Interferon-gamma in Combination With Anidulafungin for the Treatment of Candidemia
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 Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2013 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Radboud University Medical Center
Collaborators
BioMérieux

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candidemia
Keywords
candidemia, candida sepsis, invasive fungal disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interferon-gamma
Arm Type
Experimental
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
No adjunctive treatment
Intervention Type
Drug
Intervention Name(s)
Interferon-gamma, Recombinant
Intervention Description
Interferon 50 mcg/m2 to be administered three times per week during two weeks
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
overall survival
Time Frame
until 8 weeks after end of treatment
Title
time to death
Time Frame
Until 8 weeks after end of treatment
Title
outcome of fungal infection
Description
resolution at week 2 and 8 after end of treatment, patient status at end of therapy, microbiological parameters
Time Frame
Until 8 weeks after end of treatment
Title
duration of antifungal therapy
Time Frame
Until end of treatment
Title
duration of hospitalization
Time Frame
Until end of hospitilization
Title
immunological parameters
Time Frame
Until 8 weeks after end of treatment
Title
tolerability and safety
Time Frame
until 8 weeks after end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Corine Delsing, MD
Phone
+31-24-3618819
Email
C.Delsing@AIG.umcn.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Mihai Netea, MD. PhD
Phone
+31-24-3618819
Email
M.Netea@AIG.umcn.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mihai Netea, MD PhD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Corine Delsing, MD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboud University Medical Centre Nijmegen
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Corine Delsing, MD
Phone
+31-24-3618819
Email
C.Delsing@aig.umcn.nl
First Name & Middle Initial & Last Name & Degree
Corine Delsing, MD
First Name & Middle Initial & Last Name & Degree
Chantal Bleeker-Rovers, MD, PhD
First Name & Middle Initial & Last Name & Degree
Mihai Netea, MD, PhD
First Name & Middle Initial & Last Name & Degree
Bart Jan Kullberg, MD PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
24669841
Citation
Delsing CE, Gresnigt MS, Leentjens J, Preijers F, Frager FA, Kox M, Monneret G, Venet F, Bleeker-Rovers CP, van de Veerdonk FL, Pickkers P, Pachot A, Kullberg BJ, Netea MG. Interferon-gamma as adjunctive immunotherapy for invasive fungal infections: a case series. BMC Infect Dis. 2014 Mar 26;14:166. doi: 10.1186/1471-2334-14-166.
Results Reference
derived

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

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