Fluconazole Versus Micafungin in Neonates With Candidiasis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is designed to determine whether micafungin is as efficacious as the current standard of fluconazole, to compare the safety of the two drugs in the treatment of proven neonatal candidiasis.

It is also designed to further elucidate the pharmacokinetics of the two products in the growing and developing neonate and premature infant.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT03421002

Candidiasis, Systemic Candida Meningitis

COMPLETED PHASE2

An Open-Label Study of the Safety and Pharmacokinetics of Repeated-Dose Micafungin in Neonates

NCT00818584

Candida

COMPLETED PHASE1

Micafungin Versus Fluconazole in the Treatment of Invasive Candidiasis and Candidemia

NCT00189709

Invasive Candidiasis Candidemia

COMPLETED PHASE3

Fluconazole Pharmacokinetics in Infants

NCT00514358

Fungal Infection

COMPLETED

Study to Compare the Efficacy and Safety of Micafungin Versus Conventional Amphotericin B for the Treatment of Neonatal Candidiasis

NCT00815516

Candidiasis

TERMINATED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The epidemiology of candidiasis is rapidly changing; recent estimates are that nearly 50% of Candida bloodstream isolates are non-albicans Candida species requiring the use of treatments active against them.

Because of the high risk associated with candida infection in premature babies and fluconazole prophylaxis is now recommended in Neonatal Intensive Care Units (NICUs) with a high incidence in fungal infections. As candida infection is difficult to prove and requires an urgent treatment, in particular to avoid central nervous system (CNS) infection, treatment is often started in high risk patients when the infection is only suspected, i.e. on clinical arguments without waiting for positive cultures (10% of cases).

Fluconazole has not been approved for use in the treatment of neonatal candidiasis. In contrast, the efficacy of echinocandins for the treatment of invasive candidiasis has been suggested by pre-clinical and clinical studies.

Related to Micafungin, the available data suggest that only dosages that are greater than what currently recommended in infants (2 to 4 mg/kg/day) may ensure adequate coverage of the CNS, given that ability of low dosages of micafungin to penetrate the cerebrospinal compartment and to diffuse in the cerebrospinal fluid is deemed suboptimal.

The doses that will be administered are higher that currently used in order to optimize efficacy, and the concept of a loading dose that will be used for both drugs in this project, is present in antifungal treatment strategies for adults, but it has never been applied to infants and preterm neonates.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Candidiasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fluconazole

Fluconazole Kabi, Fresenius 2mg/ml

Fluconazole will be administered at a loading dose of 25 mg/kg on the first day and followed by a maintenance dose of 12 mg/kg or 20 mg/kg once daily, depending of corrected gestational age (GA) at the beginning of treatment:

* 12 mg/kg/day for neonates corrected GA (GA + postnatal age) \< 30 weeks
* 20 mg/kg/day for neonates corrected GA (GA + postnatal age) ≥ 30 weeks

The infusion will last two hours.

Group Type EXPERIMENTAL

Fluconazole

Intervention Type DRUG

Micafungin

Mycamine 50mg - 10 mg/mL of micafungin

Micafungin will be administered as a loading dose of 15 mg/kg on the first day of treatment and followed by a maintenance dose of 10 mg/kg once daily.

The infusion will last two hours.

Group Type EXPERIMENTAL

Micafungin

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fluconazole

Intervention Type DRUG

Micafungin

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Antifungal Antifungal

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Neonates and infants between 24 up to 42 weeks gestational age AND with a post-natal age of 48 hours of life up to day of life (DOL) 120 at the time of culture acquisition.
2. Requiring antifungal therapy according to medical decision by the attending physician for microbiologically documented or clinically suspected candida infection independently from the availability of any positive culture for Candida spp
3. Written informed consent from the parents or the legally authorized representative must be obtained prior to entry.
4. Infant must have sufficient venous access to permit administration of study medication and monitoring of safety variables.
5. And specifically for the French participants: infant shall be insured (Health Insurance) - able to understand and accept the study constraints

Exclusion Criteria

1. Infant exposed to fluconazole or micafungin prophylaxis prior to inclusion
2. Infant who has received more than 48 hours of systemic antifungal therapy (any product) prior to the first dose of study drug for treatment of the current Candida infection.
3. Infant with a concomitant medical condition, whose participation, in the opinion of the Investigator and/or medical advisor, may create an unacceptable additional risk.
4. Infant previously enrolled in this study.
5. Infant who is co-infected with a non-Candida fungal organism.
6. Neonates with isolated candiduria
7. Infant with any history of a hypersensitivity or severe vasomotor reaction to any echinocandin or fluconazole product
8. Infant with pre-existing hepatic or renal disease
9. Infants with baseline Candida spp. isolate resistant to fluconazole or micafungin according to "EUropean Committee on Antimicrobial Susceptibility Testing" and "Clinical and Laboratory Standards Institute" (EUCAST/CLSI) clinical breakpoints or with an isolate for which treatment with an alternative antifungal agent is indicated, i.e. there is insufficient evidence that the species in question is a good target for therapy with either fluconazole or micafungin.

Minimum Eligible Age

24 Weeks

Maximum Eligible Age

42 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No