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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003087-20 | EudraCT Number | ||
| 800_OPBG_2014 | Other Identifier | Ospedale Pediatrico Bambino Gesu Clinical & Research Center |
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| Name | Class |
|---|---|
| IRCCS, Ospedale Pediatrico Bambino Gesu | UNKNOWN |
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The primary purpose of this study is to evaluate the pharmacokinetic profile of micafungin administered to neonates suffering from systemic candidiasis. This study will also evaluate the proportion of success and of failure of the therapy with micafungin among treated neonates and will identify a conversion factor to relate plasma levels of micafungin into capillary and venous blood measured through blood samples from the heel and from a peripheral vein, collected simultaneously. Safety of micafungin in neonates will also be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Micafungin | Experimental | Participants will receive micafungin 8 mg/kg per day via intravenous infusion for approximately 1 hour. Micafungin will be administered for a minimum of 14 days until 1 of the following conditions applied: •Negative results (absence of Candida growth) from at least 2 consecutive blood cultures and/or resolution of clinical and laboratory symptoms and reduction of mannan antigen blood level (< 125 pg/mL) are obtained. •In case of meningitis, hydrocephalus and external ventricular derivation, negative results (absence of Candida growth) from at least 2 consecutive cerebral spinal fluid (CSF) cultures associated with resolution of clinical and laboratory symptoms. •Interruption (including addition or switch to another antifungal agent or dosage change of micafungin) due to demonstration of therapy failure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Micafungin | Drug | Participants will receive micafungin 8 mg/kg per day via intravenous infusion for approximately 1 hour. |
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| Measure | Description | Time Frame |
|---|---|---|
| Concentration of Micafungin in Blood | Concentration will be determined from the pharmacokinetic (PK) blood samples collected via capillary micro-method (draws from the heel). | Predose and after 1, 3, and 8 hours post-dose on one of treatment days from Day 3 to Day 10 |
| Concentration of Micafungin in Cerebral Spinal Fluid (CSF) | Concentration will be determined from the from the CSF samples collected. | Predose and after 1, 3, and 8 hours post-dose on one of treatment days from Day 3 to Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with a Response at End of Treatment (EOT) - Success of Therapy (SOT) | For systemic candidiasis (SC) participants, SOT will be determined by survival associated with negative Candida test results of 2 consecutive blood cultures, completed at start of treatment, or resolution of clinical & laboratory symptoms together with reduction of mannan antigen blood level (MABL) (<125 pg/ml). For Candida meningitis (CM), SOT will be determined by survival associated with negative Candida test results of at least 2 consecutive CSF cultures, completed at start of treatment and resolution of clinical and lab symptoms. For hydrocephalus due to Candida infection (CI) and/or external ventricular derivation (EVD), SOT will be determined by survival associated with negative Candida test results of at least 2 consecutive CSF cultures, completed at start of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Executive Medical Director | Astellas Pharma Global Development, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site IT39001 | Rome | 00146 | Italy | |||
| Site IT39002 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33558294 | Derived | Auriti C, Goffredo BM, Ronchetti MP, Piersigilli F, Cairoli S, Bersani I, Dotta A, Bagolan P, Pai MP. High-Dose Micafungin in Neonates and Young Infants with Invasive Candidiasis: Results of a Phase 2 Study. Antimicrob Agents Chemother. 2021 Mar 18;65(4):e02494-20. doi: 10.1128/AAC.02494-20. Print 2021 Mar 18. |
| Label | URL |
|---|---|
| Link to Results on the Astellas Clinical Study Results website | View source |
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Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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| ID | Term |
|---|---|
| D058365 | Candidiasis, Invasive |
| ID | Term |
|---|---|
| D002177 | Candidiasis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077551 | Micafungin |
| ID | Term |
|---|---|
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Up to day 14 |
| Percentage of Participants with A Response at EOT - Failure of Therapy (FOT) | For SC participants, FOT will be determined by death due to Candida sepsis, by confirmation of persistence of positive Candida test results from 1 blood culture completed by need to add/switch to another antifungal agent (AA) and/or change of micafungin dose for resolution of infection at any time or by the persistence of Candida colonization in different indicated sites associated with persistence of clinical and lab symptoms and with high (MABL) (≥ 125 pg/ml). For CM, FOT will be determined by death due to CM, by persistence of CI from confirmation of positive CSF culture or by need to add/switch to another AA or dose change of micafungin for resolution of CI at any time. For hydrocephalus due to CI and/or EVD, FOT will be determined by death due to CI, by need to add/switch to another AA or dose change of micafungin for resolution of CI at any time or by persistence of CI from confirmation of positive CSF culture. | Up to day 14 |
| Number of Participants with Adverse Events (AEs) | An adverse event (AE) will be defined as any untoward medical occurrence in a participant administered a study drug or who will undergo study procedures which may not necessarily have a causal relationship with this treatment. This includes abnormal laboratory tests, vital signs, electrocardiogram data or physical examinations that are defined as AEs if the abnormality will induce clinical signs or symptoms, require active intervention, interruption or discontinuation of study drug or may be clinically significant in the investigator's opinion. The following standard with 3 grades will be used to measure the severity of AEs, including abnormal clinical laboratory values: ● Mild: No disruption of normal daily activities ● Moderate: Affected normal daily activities ● Severe: Inability to perform daily activities. A treatment-emergent adverse event (TEAE) will be defined as an AE observed after starting administration of the test drug/comparative drug. | From the first dose of study drug administration up 72 hours after the last dose, up to 17 days |
| Comparison of Capillary and Venous Plasma Concentrations of Micafungin | Micafungin concentrations will be determined from the PK blood samples collected via both capillary micro-method (draws from the heel) and venous methods. | Predose and after 1, 3, and 8 hours post-dose on one of treatment days from Day 3 to Day 10 |
| Rome |
| 00186 |
| Italy |
| D000072742 |
| Invasive Fungal Infections |
| D054714 |
| Echinocandins |
| D010456 | Peptides, Cyclic |