A Phase 4 interventional study of micafungin and Micafungin in Candidemia, sponsored by Gary E. Stein, Pharm.D.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-30.
Sponsored by Gary E. Stein, Pharm.D. · Phase 4, Interventional, and Treatment
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:
65 studies on the registry are indexed under Candidemia; 4 are open to participants now.
This study's enrollment of 21 is below the median of 68 across 37 interventional studies indexed under Candidemia.
Browse Candidemia studies →Gary E. Stein, Pharm.D. is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients receive Micafungin 100 mg qd
Drug: micafungin
Patients receive 200 mg Micafungin qd
Drug: Micafungin
Patients receive caspofungin 70 mg LD followed by 50 mg qd
Drug: Caspofungin
100 mg qd by slow IV infusion for 24 h
Also known as: Micamine
200 mg qd by slow IV infusion for 24 h
Also known as: Micamine
70 mg LD followed by 50 mg qd by slow IV infusion for 24 h
Also known as: Cancidas
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).
Time frame: Pre-treatment, 1.5 hour (h), 12 h and 24 h after receiving the drug
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.
| Milestone | Micafungin (M) 100 | Micafungin (M) 200 | Caspofungin (C) 50 |
|---|---|---|---|
| Started | 8 | 8 | 5 |
| Completed | 8 | 8 | 5 |
| Not completed | 0 | 0 | 0 |
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).
| Log inhibition | Log Inhibition of 50 mg/Day Caspofungin on Candida Spp. | Log Inhibition of 100 mg/Day Micafungin on Candida Spp. | Log Inhibition of 200 mg/Day Micafungin on Candida Spp. |
|---|---|---|---|
| C. albicans MIC: C, M 0.016 mg/L | 3 ± NA | 0.5 | 0 |
| C. glabrata MIC: C, M 0.06 mg/L | 3 ± NA | 1.5 | 0.5 |
| C. glabrata MIC: C, M 0.25 mg/L | 0.5 ± NA | 1 | 0.5 |
| C. albicans 119 FKS mutant MIC:C 1, M 0.16 mg/L | 0.5 | 0.5 | 1.5 |
| C. albicans 90 FKS mutant MIC: C 1, M 0.25 mg/L | 0 | 0.5 | 2 |
| C. albicans A-15 FKS mutant MIC: C 2, M0.5 mg/L | 0 | 0 | 0 |
| C. glabrata MIC: C 2, M 0.5 mg/L | 0 | 0 | 0 |
| C. albicans 117 FKS mutant MIC: C 8, M 0.83 mg/L | 0 | 0 | 0 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Micafungin (M) 100 | — | 1/8 (12.5%) | 0/8 (0%) |
| Micafungin (M) 200 | — | 1/8 (12.5%) | 0/8 (0%) |
| Caspofungin (C) 50 | — | 0/5 (0%) | 0/5 (0%) |
| Event | Micafungin (M) 100 | Micafungin (M) 200 | Caspofungin (C) 50 |
|---|---|---|---|
| DeathCardiac disorders | 1/8 | 1/8 | 0/5 |
| Age, Categorical(Participants) | Micafungin (M) 100 | Micafungin (M) 200 | Caspofungin (C) 50 | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 4 | 4 | 11 |
| >=65 years | 5 | 4 | 1 | 10 |
| Age, Continuous(years) | Micafungin (M) 100 | Micafungin (M) 200 | Caspofungin (C) 50 | Total |
|---|---|---|---|---|
| Mean | 64.62 ± 16.13282 | 57.81 ± 17.38585 | 44.0 ± 20.43282 | 57.6 ± 18.65374 |
| Sex: Female, Male(Participants) | Micafungin (M) 100 | Micafungin (M) 200 | Caspofungin (C) 50 | Total |
|---|---|---|---|---|
| Female | 2 | 5 | 3 | 10 |
| Male | 6 | 3 | 2 | 11 |
| Region of Enrollment(participants) | Micafungin (M) 100 | Micafungin (M) 200 | Caspofungin (C) 50 | Total |
|---|---|---|---|---|
| United States | 8 | 8 | 5 | 21 |
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Gary E. Stein, Pharm.D.