CompletedPhase 2/3

Fluconazole Versus Micafungin in Neonates With Candidiasis

Belgium, France, Italy100 participantsStarted 2014-10

Plain-language summary

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.

Who can participate

Age range

24 Weeks – 42 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.
. 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
. Written informed consent from the parents or the legally authorized representative must be obtained prior to entry.
. Infant must have sufficient venous access to permit administration of study medication and monitoring of safety variables.
. And specifically for the French participants: infant shall be insured (Health Insurance) - able to understand and accept the study constraints

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Area Under the Concentration / Minimal Inhibitory Concentration ratio (AUC/MIC ratio)

Timeframe: One year

Trial details

NCT IDNCT02145832

SponsorInstitut National de la Santé Et de la Recherche Médicale, France

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2015-11

View on ClinicalTrials.gov More Candidiasis trials