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Trial Outcomes & Findings for Comparison of Candida Eradication and Serum Cidal Activity of Echinocandins (NCT NCT00839540)

NCT ID: NCT00839540

Last Updated: 2024-04-30

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

21 participants

Primary outcome timeframe

Pre-treatment, 1.5 hour (h), 12 h and 24 h after receiving the drug

Results posted on

2024-04-30

Participant Flow

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.

Participant milestones

Participant milestones
Measure
Micafungin (M) 100
Patients receive Micafungin (M) 100 mg once daily (qd)
Micafungin (M) 200
Patients receive 200 mg Micafungin (M) once daily
Caspofungin (C) 50
Patients receive caspofungin 70 mg loading dose (LD) followed by 50 mg once daily (qd)
Overall Study
STARTED
8
8
5
Overall Study
COMPLETED
8
8
5
Overall Study
NOT COMPLETED
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Candida Eradication and Serum Cidal Activity of Echinocandins

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Micafungin (M) 100
n=8 Participants
Patients receive Micafungin (M) 100 mg once daily (qd)
Micafungin (M) 200
n=8 Participants
Patients receive 200 mg Micafungin (M) once daily
Caspofungin (C) 50
n=5 Participants
Patients receive caspofungin 70 mg loading dose (LD) followed by 50 mg once daily (qd)
Total
n=21 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Age, Categorical
Between 18 and 65 years
3 Participants
n=5 Participants
4 Participants
n=7 Participants
4 Participants
n=5 Participants
11 Participants
n=4 Participants
Age, Categorical
>=65 years
5 Participants
n=5 Participants
4 Participants
n=7 Participants
1 Participants
n=5 Participants
10 Participants
n=4 Participants
Age, Continuous
64.62 years
STANDARD_DEVIATION 16.13282 • n=5 Participants
57.81 years
STANDARD_DEVIATION 17.38585 • n=7 Participants
44.0 years
STANDARD_DEVIATION 20.43282 • n=5 Participants
57.6 years
STANDARD_DEVIATION 18.65374 • n=4 Participants
Sex: Female, Male
Female
2 Participants
n=5 Participants
5 Participants
n=7 Participants
3 Participants
n=5 Participants
10 Participants
n=4 Participants
Sex: Female, Male
Male
6 Participants
n=5 Participants
3 Participants
n=7 Participants
2 Participants
n=5 Participants
11 Participants
n=4 Participants
Region of Enrollment
United States
8 participants
n=5 Participants
8 participants
n=7 Participants
5 participants
n=5 Participants
21 participants
n=4 Participants

PRIMARY outcome

Timeframe: Pre-treatment, 1.5 hour (h), 12 h and 24 h after receiving the drug

Population: Each subject received drug and had serum samples drawn at pre-treatment, 1.5h, 12h, and 24h after dosing.

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).

Outcome measures

Outcome measures
Measure
Log Inhibition of 50 mg/Day Caspofungin on Candida Spp.
n=10 blood samples
Measurement of the decrease in organism(Candida spp.) colony counts following exposure of serum containing Caspofungin based on 50 mg/day dosing, measured as Ex-vivo effect.
Log Inhibition of 100 mg/Day Micafungin on Candida Spp.
n=19 blood samples
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.
Log Inhibition of 200 mg/Day Micafungin on Candida Spp.
n=19 blood samples
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.
Serum Cidal Activity as Tested Against Various Candida Isolates and Reported as Ex-vivo Effect (Log Inhibition of Growth)
C. albicans MIC: C, M 0.016 mg/L
3 Log inhibition
NA
0.5 Log inhibition
0 Log inhibition
Serum Cidal Activity as Tested Against Various Candida Isolates and Reported as Ex-vivo Effect (Log Inhibition of Growth)
C. glabrata MIC: C, M 0.06 mg/L
3 Log inhibition
NA
1.5 Log inhibition
0.5 Log inhibition
Serum Cidal Activity as Tested Against Various Candida Isolates and Reported as Ex-vivo Effect (Log Inhibition of Growth)
C. glabrata MIC: C, M 0.25 mg/L
0.5 Log inhibition
NA
1 Log inhibition
0.5 Log inhibition
Serum Cidal Activity as Tested Against Various Candida Isolates and Reported as Ex-vivo Effect (Log Inhibition of Growth)
C. albicans 119 FKS mutant MIC:C 1, M 0.16 mg/L
0.5 Log inhibition
0.5 Log inhibition
1.5 Log inhibition
Serum Cidal Activity as Tested Against Various Candida Isolates and Reported as Ex-vivo Effect (Log Inhibition of Growth)
C. albicans 90 FKS mutant MIC: C 1, M 0.25 mg/L
0 Log inhibition
0.5 Log inhibition
2 Log inhibition
Serum Cidal Activity as Tested Against Various Candida Isolates and Reported as Ex-vivo Effect (Log Inhibition of Growth)
C. albicans A-15 FKS mutant MIC: C 2, M0.5 mg/L
0 Log inhibition
0 Log inhibition
0 Log inhibition
Serum Cidal Activity as Tested Against Various Candida Isolates and Reported as Ex-vivo Effect (Log Inhibition of Growth)
C. glabrata MIC: C 2, M 0.5 mg/L
0 Log inhibition
0 Log inhibition
0 Log inhibition
Serum Cidal Activity as Tested Against Various Candida Isolates and Reported as Ex-vivo Effect (Log Inhibition of Growth)
C. albicans 117 FKS mutant MIC: C 8, M 0.83 mg/L
0 Log inhibition
0 Log inhibition
0 Log inhibition

Adverse Events

Micafungin (M) 100

Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths

Micafungin (M) 200

Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths

Caspofungin (C) 50

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Micafungin (M) 100
n=8 participants at risk
Patients receive Micafungin (M) 100 mg once daily (qd)
Micafungin (M) 200
n=8 participants at risk
Patients receive 200 mg Micafungin (M) once daily
Caspofungin (C) 50
n=5 participants at risk
Patients receive caspofungin 70 mg loading dose (LD) followed by 50 mg once daily (qd)
Cardiac disorders
Death
12.5%
1/8 • Number of events 1
12.5%
1/8 • Number of events 1
0.00%
0/5

Other adverse events

Adverse event data not reported

Additional Information

Dr. Gary E.Stein, Pharm.D.

Michigan State University

Phone: 517-353-5126

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place