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

Phase 3

• Conditions: Candidemia
• Interventions: Drug: Interferon-gamma, Recombinant

• Registration Number: NCT01270490
• Lead Sponsor: Radboud University Medical Center

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-04
• Study First Submitted QC: 2011-01-04
• Study First Posted: 2011-01-05
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-13
• Last Update Posted: 2012-02-14
• Primary Completion: 2013-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interferon-gamma	Interferon-gamma, Recombinant	-

Primary Outcome Measures

Name	Time	Method
the time to negative blood cultures	at fixed time points during follow up (at least until 8 weeks after end of treatment)

Secondary Outcome Measures

Name	Time	Method
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	resolution at week 2 and 8 after end of treatment, patient status at end of therapy, microbiological parameters
duration of antifungal therapy	Until end of treatment
duration of hospitalization	Until end of hospitilization
immunological parameters	Until 8 weeks after end of treatment
tolerability and safety	until 8 weeks after end of treatment

Trial Locations

Locations (1)

Radboud University Medical Centre Nijmegen; 🇳🇱 Nijmegen, Netherlands