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

Candidemia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01270490
• Other study ID #: Interferon-gamma 001
• Secondary ID: 2009-014600-66NL
• Status: Recruiting
• Phase: Phase 3
• First received: January 4, 2011
• Last updated: February 13, 2012
• Start date: January 2011

Study information

• Verified date: February 2012
• Source: Radboud University
• Contact: Corine Delsing, MD
• Phone: +31-24-3618819
• Email: C.Delsing[@]AIG.umcn.nl
• Is FDA regulated: No
• Health authority: Netherlands: Ministry of Health, Welfare and Sport
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Candidemia

Intervention

Drug:
• Interferon-gamma, Recombinant
Interferon 50 mcg/m2 to be administered three times per week during two weeks

Locations

Country	Name	City	State
Netherlands	Radboud University Medical Centre Nijmegen	Nijmegen

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	BioMérieux

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the time to negative blood cultures		at fixed time points during follow up (at least until 8 weeks after end of treatment)	No
Secondary	overall survival		until 8 weeks after end of treatment	No
Secondary	time to death		Until 8 weeks after end of treatment	No
Secondary	outcome of fungal infection	resolution at week 2 and 8 after end of treatment, patient status at end of therapy, microbiological parameters	Until 8 weeks after end of treatment	No
Secondary	duration of antifungal therapy		Until end of treatment	No
Secondary	duration of hospitalization		Until end of hospitilization	No
Secondary	immunological parameters		Until 8 weeks after end of treatment	No
Secondary	tolerability and safety		until 8 weeks after end of treatment	Yes