Clinical trial NCT01270490: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Candidemia
Keywords: candidemia
candida sepsis
invasive fungal disease
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: BioMérieux
First posted: 2011-01-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: the time to negative blood cultures
timeFrame: at fixed time points during follow up (at least until 8 weeks after end of treatment)
Secondary outcomes:
measure: overall survival
timeFrame: until 8 weeks after end of treatment
measure: time to death
timeFrame: Until 8 weeks after end of treatment
measure: outcome of fungal infection
timeFrame: Until 8 weeks after end of treatment
measure: duration of antifungal therapy
timeFrame: Until end of treatment
measure: duration of hospitalization
timeFrame: Until end of hospitilization
measure: immunological parameters
timeFrame: Until 8 weeks after end of treatment
measure: tolerability and safety
timeFrame: until 8 weeks after end of treatment
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Centre Nijmegen
Study officials:
affiliation: Radboud University Medical Center
name: Mihai Netea, MD PhD
role: STUDY_DIRECTOR
affiliation: Radboud University Medical Center
name: Corine Delsing, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.