Trials / Completed
CompletedNCT03421002
Determination of Levels of Micafungin in Neonates Suffering From Systemic Candidiasis and/or Candida Meningitis
Determination of Plasmatic and CSF Levels of High Doses of Micafungin in Neonates Suffering From Systemic Candidiasis and/or Candida Meningitis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 35 (actual)
- Sponsor
- Astellas Pharma Global Development, Inc. · Industry
- Sex
- All
- Age
- 1 Day – 180 Days
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Micafungin | Participants will receive micafungin 8 mg/kg per day via intravenous infusion for approximately 1 hour. |
Timeline
- Start date
- 2015-05-30
- Primary completion
- 2018-04-10
- Completion
- 2018-04-10
- First posted
- 2018-02-05
- Last updated
- 2024-11-18
Locations
2 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT03421002. Inclusion in this directory is not an endorsement.