Anti-Infective Agents

All Drugs and Chemicals

Micafungin

Clotrimazole

Miconazole

Antifungal Agents

Echinocandins

Beta-1,3-glucan

Subjects will be administered 5 mg/kg of micafungin intravenously as a ONE TIME dose.

For patients undergoing Hematopoietic Stem Cell Transplant (HSCT), Micafungin will be given on during rest days (i.e. days when no chemotherapy is administered) and blood for pharmacokinetic measurements will be drawn over next 96 hours.

Following this, further anti-fungal coverage will be at the discretion of the patient's attending physician. (I.e. other antifungal agent(s) or Micafungin at a standard clinical dose; repeat doses of 5mg/kg will NOT be administered.)

Micafungin (trade name Mycamine) is an echinocandin antifungal drug developed by Astellas Pharma. It inhibits the production of beta-1,3-glucan, an essential component of fungal cell walls. Micafungin is administered intravenously. It received final approval from the U.S. Food and Drug Administration on March 16, 2005, and gained approval in the European Union on April 25, 2008.

Parinda Mehta, MD

The purpose of this research study is to examine the pharmacokinetics (the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body) of micafungin when it is given at 5mg/kg dose to immunocompromised children as anti-fungal prophylaxis. These children are at high risk for developing invasive fungal disease due to their compromised immunity and associated variable degree and duration of neutropenia. Currently, children who receive micafungin are given daily or alternate day dosing. The investigators will give a ONE TIME dose of micafungin and draw PK levels up to 96 hours post-infusion. The investigators goal is to obtain comparable micafungin drug concentrations at the end of 96 hours (4 days) as compared to lower dose at every 24 hour dosing. The investigators dosing proposal is likely to be effective prophylaxis for immunocompromised patients and would broaden its applicability to larger populations.

Disseminated fungal infection is a major cause of morbidity and mortality in immunocompromised children. Many of the drugs used for fungal prophylaxis have been associated with renal and hepatic toxicity. Also, breakthrough infections have been reported with the use of some of the oral agents due to poor oral absorption. An alternative approach is the use of intravenous micafungin for fungal prophylaxis. Micafungin has a distinct advantage due to its better safety profile, specifically in terms of hepatic and renal toxicity. Currently, children who receive micafungin are given daily or alternate day dosing (based on their last Pk study, Mehta et al 2010). The investigators objective is to examine the pharmacokinetics of micafungin when it is given on a less frequent schedule. The investigators hypothesize that a single dose of micafungin (at 5mg/kg) every 4 days will provide drug exposure equivalent to daily dosing (at 1mg/kg) while reducing administration costs and improving patient convenience (with essentially twice a week dosing regimen). Both animal and adult data support the use of this approach. Fifteen patients will be enrolled on this study and will be given a SINGLE DOSE of micafungin antifungal prophylaxis (5 mg/kg). Blood samples will be drawn for pharmacokinetic measurements after administration of micafungin. Plasma concentration data will be analyzed by compartmental and non-compartmental pharmacokinetic analysis. The data will also be analyzed by a population pharmacokinetic approach.

A Pharmacokinetic Study of Pediatric Micafungin Prophylaxis

Micafungin Anti-Fungal Prophylaxis in Immunocompromised Pediatric Patients: A Pharmacokinetic Study

Blood samples from the above time points will be analyzed to study the bodily absorption, distribution, metabolism, and excretion of micafungin

Astellas Pharma Inc

Children's Hospital Medical Center, Cincinnati

Neoplasms

Blood and Lymph Conditions

All Conditions

Symptoms and General Pathology

Rare Diseases

Leukemia

Acute Disease

Neoplasms by Histologic Type

Hematologic Diseases

Disease Attributes

Acute Graft Versus Host Disease

Patients received 50 mg micafungin intravenously once daily from the initiation of induction chemotherapy to recovery of neutrophil count (absolute neutrophil count \> 500/μg for three consecutive days), suspected fungal infection, or occurrence of drug-related toxicity.

Youngil Koh, Dr.

The purpose of this study is to determine whether prophylaxis with micafungin is effective in the induction chemotherapy for newly diagnosed acute leukemia patients.

Medically fit patients with newly diagnosed acute leukemia received 50 mg micafungin intravenously once daily from the initiation of first induction chemotherapy to recovery of neutrophil count, suspected fungal infection, or unacceptable drug-related toxicity.

Micafungin Prophylaxis During 1st Induction Chemotherapy for De Novo Acute Leukemia

Phase II Trial of Micafungin Prophylaxis During Induction Chemotherapy for Patients With Acute Leukemia

proven fungal infection: proven by positive culture for fungus with symptoms and signs of a fungal infection probable fungal infection: direct or indirect detection (galactomannan antigen or serum β-D-glucan) with clinical and radiographic findings possible fungal infection: sufficient clinical evidence for fungal infection was present without mycological evidence

The survival of patients till 12 weeks after induction chemotherapy

The outcomes of non-relapse mortality: The incidence of death without a previous relapse or progression

Seoul National University Hospital

Serious adverse events: life-threatening adverse events Other adverse events: non-serious adverse events during treatment

Adverse Events

The baseline characteristics of total patients

Micafungin Prophylaxis

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

South Korea

Region of Enrollment

Pf. Youngil Koh

Number of Participants With Proven/Probable/Possible Invasive Fungal Infection

Survival Outcome

Overall Survival

Non-relapse mortality was defined as the incidence of death without a previous relapse or progression.

Non-relapse Mortality

50 mg micafungin intravenously once daily from the initiation of induction chemotherapy to recovery of neutrophil count (absolute neutrophil count \> 500/μg for three consecutive days), suspected fungal infection, or occurrence of drug-related toxicity

Overall Study

Infections

Immune System Diseases

Syndrome

Mycoses

Invasive Fungal Infections

Graft vs Host Disease

Preleukemia

Myelodysplastic Syndromes

Communicable Diseases

Bacterial Infections

Bacterial Infections and Mycoses

Bone Marrow Diseases

Precancerous Conditions

Homologous Wasting Disease

treatment for 8 days with intravenous micafungin twice weekly

alternate dosing

daily dosing

micafungin

Roger Brüggemann

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

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.

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

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.

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

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Pharmacokinetic Study of Pediatric Micafungin Prophylaxis	NCT02057289	Immunocompromis... Bone Marrow Tra... Cancer	Micafungin	6 Months - 10 Years	Children's Hospital Medical Center, Cincinnati
A Pharmacokinetic Study of Pediatric Micafungin Prophylaxis	NCT02057289	Immunocompromis... Bone Marrow Tra... Cancer	Micafungin	6 Months - 10 Years	Children's Hospital Medical Center, Cincinnati
Micafungin Prophylaxis During 1st Induction Chemotherapy for De Novo Acute Leukemia	NCT02440178	Acute Leukemia	Micafungin	18 Years - 75 Years	Seoul National University Hospital
Pharmacokinetics of Micafungin Given Twice Weekly Intravenously Compared to Micafungin Given Daily to Patients at Risk for Developing an Invasive Fungal Disease	NCT02172768	Acute Graft Ver... Allogeneic Stem... Acute Myeloid L... Myelo Dysplasti...	alternate dosin... daily dosing micafungin	18 Years -	Radboud University Medical Center
Pharmacokinetics of Micafungin Given Twice Weekly Intravenously Compared to Micafungin Given Daily to Patients at Risk for Developing an Invasive Fungal Disease	NCT02172768	Acute Graft Ver... Allogeneic Stem... Acute Myeloid L... Myelo Dysplasti...	alternate dosin... daily dosing micafungin	18 Years -	Radboud University Medical Center

Spots Global Cancer Trial Database for micafungin

Every month we try and update this database with for micafungin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for micafungin

Every month we try and update this database with for micafungin cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for micafungin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.