A Phase 2 interventional study of Micafungin in Candidiasis, Systemic and Candida Meningitis, sponsored by Astellas Pharma Global Development, Inc.. Completed at 2 sites in Italy. Open to participants aged 1 Day to 180 Days. Per ClinicalTrials.gov, last updated 2024-11-18.
Sponsored by Astellas Pharma Global Development, Inc. (part of Astellas Pharma Inc) · Phase 2, Interventional, and Treatment
Among 14 studies in Candidiasis, Invasive with a site in Italy — 1 open to participants now, 1 under way, 1 of them phase 3. Candidiasis, Invasive · Italy.
Among the 14 studies in Candidiasis, Invasive with a site in Italy, this one is the 10th largest by enrollment of the 13 interventional ones that give a count, is the only one that started in 2015, is one of 2 in phase 2, and was the 8th registered.
65 studies on the registry are indexed under Candidiasis, Invasive; 6 are open to participants now.
Browse Candidiasis, Invasive studies →1 of the 14 studies in Candidiasis, Invasive with a site in Italy is open now. Recruiting first, the newest first:
Basilea Pharmaceutica · Sites in Italy, United States, Argentina and 17 more countries
Ages 18+
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 5 Candidiasis, Invasive studies recruiting now, 5 set no upper age limit and none stop at 75 or younger; 3 take children under 18; none take healthy volunteers.
This study: 1 Day to 180 Days · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
14 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 1 started in 2015.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 35 is below the median of 60 across 47 interventional studies indexed under Candidiasis, Invasive.
Median enrollment 70 across the 13 interventional studies, 0 across the 1 observational. Of the 12 that completed or were terminated, 7 (58%) have results posted.
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11 of 14 have an industry lead sponsor. The 10 most frequent:
This study is registered under Astellas Pharma Global Development, Inc., one of the names counted as Astellas Pharma Inc. Under that name alone:
Astellas Pharma Global Development, Inc. is the lead sponsor of 207 studies on the registry; 23 are open to participants now.
Of its 82 completed or terminated interventional studies of FDA-regulated products, 38 (46%) have results posted.
Astellas Pharma Inc has 6 studies filed under Candidiasis, Invasive — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 14 studies in Candidiasis, Invasive with a site in Italy, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Micafungin
Participants will receive micafungin 8 mg/kg per day via intravenous infusion for approximately 1 hour.
Also known as: Mycamine
Concentration of Micafungin in Blood
Concentration will be determined from the pharmacokinetic (PK) blood samples collected via capillary micro-method (draws from the heel).
Time frame: 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.
Time frame: Predose and after 1, 3, and 8 hours post-dose on one of treatment days from Day 3 to Day 10
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Predose and after 1, 3, and 8 hours post-dose on one of treatment days from Day 3 to Day 10
Plan to share: No — 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/.
Ran from May 2015 to primary completion in Apr 2018, 34 months.
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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Micafungin
Astellas Pharma Global Development, Inc. →