NCT01270490

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 5, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Last Updated

February 14, 2012

Status Verified

February 1, 2012

Enrollment Period

2 years

First QC Date

January 4, 2011

Last Update Submit

February 13, 2012

Conditions

Candidemia

Keywords

candidemiacandida sepsisinvasive fungal disease

Outcome Measures

Primary Outcomes (1)

  • the time to negative blood cultures

    at fixed time points during follow up (at least until 8 weeks after end of treatment)

Secondary Outcomes (7)

  • overall survival

    until 8 weeks after end of treatment

  • time to death

    Until 8 weeks after end of treatment

  • outcome of fungal infection

    Until 8 weeks after end of treatment

  • duration of antifungal therapy

    Until end of treatment

  • duration of hospitalization

    Until end of hospitilization

  • +2 more secondary outcomes

Study Arms (2)

Interferon-gamma

EXPERIMENTAL
Drug: Interferon-gamma, Recombinant

No intervention

NO INTERVENTION

No adjunctive treatment

Interventions

Interferon-gamma, RecombinantDRUG

Interferon 50 mcg/m2 to be administered three times per week during two weeks

Interferon-gamma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Medical Centre Nijmegen

Nijmegen, 6525 GA, Netherlands

RECRUITING

Related Publications (1)

  • 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.

    PMID: 24669841DERIVED

MeSH Terms

Conditions

CandidemiaInvasive Fungal Infections

Interventions

Interferon-gamma

Condition Hierarchy (Ancestors)

Candidiasis, InvasiveCandidiasisMycosesBacterial Infections and MycosesInfectionsFungemiaSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

InterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsMacrophage-Activating FactorsLymphokinesProteinsBiological Factors

Study Officials

  • Mihai Netea, MD PhD

    Radboud University Medical Center

    STUDY DIRECTOR

  • Corine Delsing, MD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Corine Delsing, MD

CONTACT

+31-24-3618819C.Delsing@AIG.umcn.nl

Mihai Netea, MD. PhD

CONTACT

+31-24-3618819M.Netea@AIG.umcn.nl

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Drs

Study Record Dates

First Submitted

January 4, 2011

First Posted

January 5, 2011

Study Start

January 1, 2011

Primary Completion

January 1, 2013

Last Updated

February 14, 2012

Record last verified: 2012-02

Locations

NL(1)