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
- Conditions
- candidemiafungal bloodstream infection1002146010017528
- Registration Number
- NL-OMON35641
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
• 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 canidiasis
•Subject or their legal representative must sign a written informed consent form.
• Subjects with a history of allergy or intolerance to echinocandins or Interferon gamma
• 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
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is the time to negative blood cultures.<br /><br></p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints are<br /><br>• The overall survival<br /><br>• Mortality at week 2 and week 8 after end of treatment (all causes)<br /><br>• Time to death<br /><br>• Outcome of fungal infection:<br /><br>o Resolution of infection at week 2 and 8 after end of treatment<br /><br>o Evaluation of patient status (succes, failure, death) at end of interferon<br /><br>gamma (and at time of stopping antifungal treatment)<br /><br>o Microbiological evaluation<br /><br>• Duration of antifungal treatment<br /><br>• Duration of hospitalization<br /><br>• Immunological parameters<br /><br>• Evaluation of host respons markers that can be used to identify patients with<br /><br>immunoparalysis that will benefit from immunotherapy<br /><br>• Monitoring the immunological respons to interferon-gamma</p><br>