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

NCT02172768 | Completed Phase 2

• 1 other identifier: MATADOR
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

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

Keywords

pharmacokinetics; alternate dosing; micafungin

Outcome Measures

Primary Outcomes (1)

• area under the curve

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

  day 4 and day 8

Secondary Outcomes (2)

• population PK model

  Day 4 and Day 8

• adverse events

  day 1- 11

Study Arms (2)

alternate dosing

EXPERIMENTAL

treatment for 8 days with intravenous micafungin twice weekly

Other: alternate dosing; Drug: micafungin

daily dosing

ACTIVE COMPARATOR

micafungin daily for 8 days

Other: daily dosing; Drug: micafungin

Interventions

alternate dosing OTHER

treatment for 8 days with intravenous micafungin twice weekly

Also known as: micafungin

alternate dosing

daily dosing OTHER

micafungin daily for 8 days

daily dosing

micafungin DRUG

alternate dosing; daily dosing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (2)

UZ Leuven

Leuven, Belgium

Location

Radboudumc

Nijmegen, Netherlands

Location

Related Publications (1)

• Muilwijk EW, Maertens JA, van der Velden WJFM, Ter Heine R, Colbers A, Burger DM, Andes D, Theunissen K, Blijlevens NMA, Bruggemann RJM. Pharmacokinetics of extended dose intervals of micafungin in haematology patients: optimizing antifungal prophylaxis. J Antimicrob Chemother. 2018 Nov 1;73(11):3095-3101. doi: 10.1093/jac/dky324.

  PMID: 30137340 RESULT

MeSH Terms

Interventions

Micafungin

Intervention Hierarchy (Ancestors)

Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Echinocandins; Peptides, Cyclic

Study Officials

• Roger Brüggemann

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: June 24, 2014
• Study Start: October 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: July 1, 2016
• Last Updated: December 8, 2020

Record last verified: 2020-12

Locations

BE (1); NL (1)