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Determination of Levels of Micafungin in Neonates Suffering from Systemic Candidiasis and/or Candida Meningitis

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT03421002

Astellas Study ID

The unique identification code given by the study sponsor.

9463-CL-6001

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

2014-003087-20

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Condition

Infections

Phase

These clinical trials are done to learn if an experimental treatment helps participants who have a specific condition or disease. Phase 2 trials usually include a larger group of participants than Phase 1 trials.

Phase 2

Age

1 days - 180 days

Sex

Female & Male

Product

N/A

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

May 2015 - Apr 2018

Masking

None (Open Label)

Enrollment number

35

Determination of Plasmatic and CSF Levels of High Doses of Micafungin in Neonates Suffering from Systemic Candidiasis and/or Candida Meningitis

Study summary

Study documents

Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.

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Locations

Site IT39001

Rome, Italy, 00146

Site IT39002

Rome, Italy, 00186

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