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Completed

NCT Number: NCT02172768

Pharmacokinetics of Micafungin Given Twice Weekly Intravenously Compared to Micafungin Given Daily to Patients at Risk for Developing an Invasive Fungal Disease

The primary objective of this trial is as follows:

To determine the pharmacokinetics of micafungin given twice weekly in patients at risk for developing an invasive fungal disease (patients who are being treated for acute or chronic graft versus host disease; patients receiving reduced intensity conditioning for Stem Cell Transplant (SCT); receiving first remission induction chemotherapy for Acute Myeloid Leucaemia (AML)/MyeloDysplasticSyndrome (MDS)) compared to the pharmacokinetics of micafungin given daily.

The secondary objective of this trial is as follows:

To determine whether adequate exposure of micafungin is attained. To determine the safety of micafungin in this patient population

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Key information

Conditions

Acute Graft Versus Host Disease Grade II-IV Acute Myeloid Leucaemia Allogeneic Stem Cell Transplant Myelo Dysplastic Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UZ Leuven, Leuven, Belgium

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About this study

Micafungin has been shown to be a reasonable option for treating invasive aspergillosis in hematopoietic stem cell transplantation (HSCT) recipients and has proven as effective as fluconazole for prophylaxis. Whilst micafungin has much to offer, little is known about its pharmacokinetic profile in specific patient populations, specifically concerning alternate dosing strategies with increased dosages over a prolonged dosing interval. Sufficient data are lacking up to now for twice weekly administration of micafungin as antifungal prophylaxis. Decreasing the dosing frequency to twice weekly seems a reasonable approach considering the long terminal elimination life (i.e. 10-17 h) and considering the data available from murine models that support the use of less frequent dosing with higher dosages.

It will enable us to characterize both the pharmacokinetics of micafungin in the hematology cohort and directly compare the exposure to the alternate dosing strategy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient receives immunosuppressive therapy for acute GvHD grade II-IV or reduced intensity conditioning regimens for allogeneic stem cell transplant, or patients receiving first remission induction chemotherapy for AML/MDS.
  • Subject is at least 18 of age on the day of providing informed consent.
  • Has no signs or symptoms of invasive fungal disease
  • If a woman, is neither pregnant nor able to become pregnant and is not nursing an infant.
  • Less than 1 week of immunosuppressive therapy for grade II-IV acute GvHD.
  • Is managed with a central venous catheter (preferably a quadruple Arrow-Howes™ Quad-Lumen 8.5,5 French; Arrow International).
  • Subject is able and willing to sign the Informed Consent before screening evaluations.

Exclusion criteria

  • Documented history of sensitivity to medicinal products or excipients similar to those found in the micafungin preparation.
  • History of or current abuse of drugs, alcohol or solvents.
  • Inability to understand the nature of the trial and the procedures required.
  • Has not previously participated in this trial.

Treatment and study plan

alternate dosing

Other

treatment for 8 days with intravenous micafungin twice weekly

Other names: micafungin

daily dosing

Other

micafungin daily for 8 days

Micafungin

Drug

Primary outcomes

  1. area under the curve

    Time frame: day 4 and day 8

    Full pharmacokinetic curves will be taken op Day 4 or 5 and Day 8 (micafungin). AUC of two dosing regimens will be compared.

Secondary outcomes

  1. population PK model

    Time frame: Day 4 and Day 8

    to perform Monte Carlo simulations to provide the scientific background for alternate dosing strategies in the prophylactic setting

  2. adverse events

    Time frame: day 1- 11

    number and severity of adverse events will be recorded during the study and both treatment regimens will be compared

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

Pharmacokinetics of Micafungin (Mycamin ®) as Antifungal Prophylaxis Given Twice Weekly Intravenously Compared to Micafungin Given Daily to Patients at Risk for Developing an Invasive Fungal Disease.

Acronym: MATADOR

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 24, 2014
Registry last updated
Dec 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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