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| Name | Class |
|---|---|
| Astellas Pharma US, Inc. | INDUSTRY |
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The purpose of this pharmacokinetic (PK) and pharmacodynamic (PD) study is:
To study the rate and duration of serum cidal activity of caspofungin (CFG) and micafungin (MFG) against Candida isolates from the subject and against Candida glabrata with varying degrees of caspofungin susceptibilities.
This investigation will provide clinicians information supporting the use of caspofungin and micafungin in situations where Candida strains may be a cause of infection.
Methods:
Patients - Adult patients with presumptive candidemia. Patients with severe neutropenia (<500) APACHE II scores > 20, or significant liver disease will be excluded. All will give written informed consent (Pappas et al. CID. Oct 1, 2007).
Drugs - Patients will receive either CFG: 70 mg loading dose (LD) followed by 50 mg once daily (qd) (8 patients), MFG: 100 mg qd (8 patients) or MFG: 200 mg qd (8 patients). All agents will be given by slow IV infusion (MFG will be supplied by Astellas).
Sera - Blood samples will be collected at the end of the infusion (peak) and at 12 h and 24 h (trough) after the beginning of an infusion (day 3-4).
Each patients sera will be tested (MIC and cidal activity) against their own Candida isolate (if isolated). In addition, recent clinical isolates of C. glabrata will also be tested against patient sera (time-kill) to verify previous in vitro and animal PD studies (Cota. AAC. Nov. 2006; Wiederhold. AAC. May 2007).
Results:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| micafungin 100 | Active Comparator | Patients receive Micafungin 100 mg qd |
|
| micafungin 200 | Active Comparator | Patients receive 200 mg Micafungin qd |
|
| Caspofungin | Active Comparator | Patients receive caspofungin 70 mg LD followed by 50 mg qd |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| micafungin | Drug | 100 mg qd by slow IV infusion for 24 h |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum Cidal Activity as Tested Against Various Candida Isolates and Reported as Ex-vivo Effect (Log Inhibition of Growth) | Serum cidal activity of serum collected at different timepoints from the patients will be tested against various Candida isolates and the ex-vivo effect reported as log inhibition (logrithmic measurement of the decrease in microbiological growth). These Candida isolates had a range of minimum inhibitory concentrations (MIC) to Caspofungin (C) and Micafungin (M). | Pre-treatment, 1.5 hour (h), 12 h and 24 h after receiving the drug |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gary E Stein, Pharm.D. | Michigan State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sparrow Hospital | Lansing | Michigan | 48912 | United States |
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Subjects were inpatients (Sparrow Hospital) with probable fungal infections that required treatment with an antifungal; referral base was infectious disease consultations. The first subject was enrolled 12/24/08, with the last subject enrolled on 1/15/10.
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| ID | Title | Description |
|---|---|---|
| FG000 | Micafungin (M) 100 | Patients receive Micafungin (M) 100 mg once daily (qd) |
| FG001 | Micafungin (M) 200 | Patients receive 200 mg Micafungin (M) once daily |
| FG002 | Caspofungin (C) 50 | Patients receive caspofungin 70 mg loading dose (LD) followed by 50 mg once daily (qd) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Micafungin (M) 100 | Patients receive Micafungin (M) 100 mg once daily (qd) |
| BG001 | Micafungin (M) 200 | Patients receive 200 mg Micafungin (M) once daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Serum Cidal Activity as Tested Against Various Candida Isolates and Reported as Ex-vivo Effect (Log Inhibition of Growth) | Serum cidal activity of serum collected at different timepoints from the patients will be tested against various Candida isolates and the ex-vivo effect reported as log inhibition (logrithmic measurement of the decrease in microbiological growth). These Candida isolates had a range of minimum inhibitory concentrations (MIC) to Caspofungin (C) and Micafungin (M). | Each subject received drug and had serum samples drawn at pre-treatment, 1.5h, 12h, and 24h after dosing. | Posted | Number | Log inhibition | Pre-treatment, 1.5 hour (h), 12 h and 24 h after receiving the drug | blood samples | blood samples |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Micafungin (M) 100 | Patients receive Micafungin (M) 100 mg once daily (qd) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders | Systematic Assessment | Death due to disease progression (fungal infection), not related to study participation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gary E.Stein, Pharm.D. | Michigan State University | 517-353-5126 | steing@msu.edu |
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| ID | Term |
|---|---|
| D058387 | Candidemia |
| ID | Term |
|---|---|
| D058365 | Candidiasis, Invasive |
| D002177 | Candidiasis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D000077551 | Micafungin |
| D000077336 | Caspofungin |
| ID | Term |
|---|---|
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Micafungin | Drug | 200 mg qd by slow IV infusion for 24 h |
|
|
| Caspofungin | Drug | 70 mg LD followed by 50 mg qd by slow IV infusion for 24 h |
|
|
| BG002 | Caspofungin (C) 50 | Patients receive caspofungin 70 mg loading dose (LD) followed by 50 mg once daily (qd) |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Log Inhibition of 100 mg/Day Micafungin on Candida Spp. | Measurement of the decrease in organism(Candida spp.) colony counts following exposure of serum containing Micafungin based on 100 mg/day dosing, measured as Ex-vivo effect. |
| OG002 | Log Inhibition of 200 mg/Day Micafungin on Candida Spp. | Measurement of the decrease in organism(Candida spp.) colony counts following exposure of serum containing Micafungin based on 200 mg/day dosing, measured as Ex-vivo effect. |
|
|
| 1 |
| 8 |
| 0 |
| 8 |
| EG001 | Micafungin (M) 200 | Patients receive 200 mg Micafungin (M) once daily | 1 | 8 | 0 | 8 |
| EG002 | Caspofungin (C) 50 | Patients receive caspofungin 70 mg loading dose (LD) followed by 50 mg once daily (qd) | 0 | 5 | 0 | 5 |
|
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| D007239 |
| Infections |
| D000072742 | Invasive Fungal Infections |
| D016469 | Fungemia |
| D018805 | Sepsis |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D054714 |
| Echinocandins |
| D010456 | Peptides, Cyclic |