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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-014600-66 | EudraCT Number | ||
| NL28823.091.10 | Other Identifier | Dutch Central Committee on Research inv. Human Subjects |
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| Name | Class |
|---|---|
| BioMérieux | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interferon-gamma | Experimental |
| |
| No intervention | No Intervention | No adjunctive treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interferon-gamma, Recombinant | Drug | Interferon 50 mcg/m2 to be administered three times per week during two weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| the time to negative blood cultures | at fixed time points during follow up (at least until 8 weeks after end of treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | until 8 weeks after end of treatment | |
| time to death | Until 8 weeks after end of treatment | |
| outcome of fungal infection |
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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:
Subject or their legal representative must sign a written informed consent form.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Corine Delsing, MD | Contact | +31-24-3618819 | C.Delsing@AIG.umcn.nl | |
| Mihai Netea, MD. PhD | Contact | +31-24-3618819 | M.Netea@AIG.umcn.nl |
| Name | Affiliation | Role |
|---|---|---|
| Mihai Netea, MD PhD | Radboud University Medical Center | Study Director |
| Corine Delsing, MD | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud University Medical Centre Nijmegen | Recruiting | Nijmegen | 6525 GA | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24669841 | Derived | 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. |
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| ID | Term |
|---|---|
| D058387 | Candidemia |
| D000072742 | Invasive Fungal Infections |
| ID | Term |
|---|---|
| D058365 | Candidiasis, Invasive |
| D002177 | Candidiasis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D007371 | Interferon-gamma |
| ID | Term |
|---|---|
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
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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 |
| 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 |
| D007239 |
| Infections |
| D016469 | Fungemia |
| D018805 | Sepsis |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D016215 | Macrophage-Activating Factors |
| D008222 | Lymphokines |
| D011506 | Proteins |
| D001685 | Biological Factors |