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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

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

NCT ID

NCT01270490

First Posted

January 4, 2011

Last Updated

February 13, 2012

Sponsor

Radboud University Medical Center

Collaborators

BioMérieux

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

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

C.Delsing@AIG.umcn.nl

First Name & Middle Initial & Last Name or Official Title & Degree

Mihai Netea, MD. PhD

Phone

+31-24-3618819

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

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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