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Echinocandins

micafungin 100 for Candida Blood Infection

Phase 4
Waitlist Available
Led By Gary E Stein, Pharm.D.
Research Sponsored by Gary E. Stein, Pharm.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Adult patients with presumptive candidemia
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-treatment, 1.5 hour (h), 12 h and 24 h after receiving the drug
Awards & highlights
Approved for 10 Other Conditions
All Individual Drugs Already Approved
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

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.

Eligible Conditions
  • Candida Blood Infection
  • Candidemia

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-treatment, 1.5 hour (h), 12 h and 24 h after receiving the drug
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-treatment, 1.5 hour (h), 12 h and 24 h after receiving the drug for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Serum Cidal Activity as Tested Against Various Candida Isolates and Reported as Ex-vivo Effect (Log Inhibition of Growth)

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Active Control
Group I: micafungin 100Active Control1 Intervention
Patients receive Micafungin 100 mg qd
Group II: micafungin 200Active Control1 Intervention
Patients receive 200 mg Micafungin qd
Group III: CaspofunginActive Control1 Intervention
Patients receive caspofungin 70 mg LD followed by 50 mg qd

Find a Location

Who is running the clinical trial?

Gary E. Stein, Pharm.D.Lead Sponsor
3 Previous Clinical Trials
34 Total Patients Enrolled
Astellas Pharma US, Inc.Industry Sponsor
88 Previous Clinical Trials
12,816 Total Patients Enrolled
Gary E Stein, Pharm.D.Principal InvestigatorMichigan State University
1 Previous Clinical Trials
12 Total Patients Enrolled
~1 spots leftby Nov 2025
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