Efficacy of Interferon-gamma in Combination With Anidulafungin for the Treatment of Candidemia
NCT ID: NCT01270490
Last Updated: 2012-02-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
20 participants
INTERVENTIONAL
2011-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Interferon-gamma
Interferon-gamma, Recombinant
Interferon 50 mcg/m2 to be administered three times per week during two weeks
No intervention
No adjunctive treatment
No interventions assigned to this group
Interventions
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Interferon-gamma, Recombinant
Interferon 50 mcg/m2 to be administered three times per week during two weeks
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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BioMérieux
INDUSTRY
Radboud University Medical Center
OTHER
Responsible Party
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Corine Delsing
Drs
Principal Investigators
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Mihai Netea, MD PhD
Role: STUDY_DIRECTOR
Radboud University Medical Center
Corine Delsing, MD
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
Locations
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Radboud University Medical Centre Nijmegen
Nijmegen, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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2009-014600-66
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NL28823.091.10
Identifier Type: OTHER
Identifier Source: secondary_id
Interferon-gamma 001
Identifier Type: -
Identifier Source: org_study_id
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