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

Radboud University Medical Center

Status and phase

Unknown

Phase 3

Conditions

Candidemia

Treatments

Drug: Interferon-gamma, Recombinant

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01270490

2009-014600-66 (EudraCT Number)

NL28823.091.10 (Other Identifier)

Interferon-gamma 001

Details and patient eligibility

About

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

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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