Ended Human Pharmacology (Phase I)- Other Fungal infections

A Phase 1, Multicentre, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single IV Dose of Rezafungin Acetate in Paediatric Subjects from Birth to <18 Years of Age, Receiving Systemic Antifungals as Prophylaxis for Invasive Fungal Infection or to Treat a Suspected or Confirmed Fungal Infection

EU CTIS ID: 2022-501985-23-00

What this study is testing

To evaluate the pharmacokinetics (PK) of a single IV dose of rezafungin in paediatric subjects from birth to <18 years, receiving concomitant systemic antifungals as prophylaxis for invasive fungal infection (IFI) or to treat a suspected or confirmed fungal infection

  • Human Pharmacology (Phase I)- Other

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Male or female paediatric subjects from birth to <18 years of age who are receiving concomitant systemic antifungals (oral or IV) as prophylaxis for IFI or to treat a suspected or confirmed fungal infection.

You likely can't join if

  • History of anaphylaxis, hypersensitivity, or any serious reaction to the echinocandin class of antifungals and/or excipients of this formulation;
  • Previous or current medical conditions of severe ataxia, persistent tremors, intracranial haemorrhage or neuropathy, or a diagnosis of epilepsy, multiple sclerosis, or a movement disorder (including, but not limited to, cerebral palsy and muscular dystrophy);
  • Subjects with impaired renal or hepatic functions (alanine aminotransferase or aspartate aminotransferase >3 times the upper limit of normal, conjugated bilirubin >24 µmol/L [1.4 mg/dL], serum creatinine >177 µmol/L [2 mg/dL], or receiving renal replacement therapy);
  • Subjects with intestinal hypoxia, ischaemia, necrosis, or necrotising enterocolitis;
  • Subject status is unstable (e.g., with sepsis or disseminated intravascular coagulation), and subject is unlikely to complete required study procedures;
  • Participation in another interventional treatment trial with an investigational agent or presence of an investigational device at the time of informed consent or within 28 days preceding the informed consent.

The study team makes the final eligibility decision.

Where it's taking place

  • United Kingdom

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.