Trial Outcomes & Findings for Anidulafungin In Treatment Of Candidemia In Asian Subjects (NCT NCT00537329)
NCT ID: NCT00537329
Last Updated: 2010-03-09
Results Overview
Number of subjects with clinician assessed global response of success; defined as cure (resolution of signs and symptoms of Candida infection) or improvement (significant but incomplete resolution of signs and symptoms of Candida infection) on the clinical response in conjunction with eradication (follow up negative culture result for Candida species \[spp\]) or presumed eradication (follow up culture was not available and clinical outcome defined as success) on the microbiological response.
COMPLETED
PHASE3
43 participants
End of treatment (EOT) = Day 5 up to Day 42
2010-03-09
Participant Flow
Approximately 100 eligible subjects from 22 centers were planned to be enrolled. However, due to slow enrollment, 46 subjects were screened and 43 subjects were assigned to treatment.
Participant milestones
| Measure |
Anidulafungin
Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
|
|---|---|
|
Overall Study
STARTED
|
43
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
26
|
Reasons for withdrawal
| Measure |
Anidulafungin
Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
|
|---|---|
|
Overall Study
Death
|
10
|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Lack of Efficacy
|
2
|
|
Overall Study
Lost to Follow-up
|
6
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Other
|
1
|
Baseline Characteristics
Anidulafungin In Treatment Of Candidemia In Asian Subjects
Baseline characteristics by cohort
| Measure |
Anidulafungin
n=43 Participants
Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
|
|---|---|
|
Age, Customized
Between 18 and 44 years
|
10 participants
n=5 Participants
|
|
Age, Customized
Between 45 and 64 years
|
15 participants
n=5 Participants
|
|
Age, Customized
≥ 65 years
|
18 participants
n=5 Participants
|
|
Age Continuous
|
56.5 years
STANDARD_DEVIATION 18.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: End of treatment (EOT) = Day 5 up to Day 42Population: Modified Intent to Treat (MITT): includes all Full Analysis Set (FAS) subjects (received at least 1 dose of study treatment) with confirmed, documented diagnosis of candidemia and had received the initial loading dose of study treatment.
Number of subjects with clinician assessed global response of success; defined as cure (resolution of signs and symptoms of Candida infection) or improvement (significant but incomplete resolution of signs and symptoms of Candida infection) on the clinical response in conjunction with eradication (follow up negative culture result for Candida species \[spp\]) or presumed eradication (follow up culture was not available and clinical outcome defined as success) on the microbiological response.
Outcome measures
| Measure |
Anidulafungin
n=42 Participants
Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
|
|---|---|
|
Number of Subjects With Global Response of Success at End of Treatment
|
31 participants
|
SECONDARY outcome
Timeframe: End of intravenous treatment (EOIT), end of Week 2 after EOT (2 Wks post EOT), end of Week 6 after EOT (6 Wks post EOT), at end of 12 weeks after baseline (12 Wks post baseline)Population: MITT; EOT visit could occur anytime from Day 5 through Day 42; if a subject terminated early, the timeframe "at end of 12 weeks after baseline" could occur in the follow-up period (6 Wks post EOT or Week 12 post EOT).
Number of subjects with clinician assessed global response of success. Defined as cure or improvement (cure/improvement): cure=resolution of signs and symptoms of Candida infection; improvement=significant but incomplete resolution of signs and symptoms of Candida infection on the clinical response in conjunction with eradication or presumed eradication (erad/presumed erad): erad=follow up negative culture result for Candida spp; presumed erad=follow up culture was not available and clinical outcome defined as success on the microbiological response.
Outcome measures
| Measure |
Anidulafungin
n=42 Participants
Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
|
|---|---|
|
Number of Subjects With Global Response of Success at Endpoints
EOIT
|
33 participants
|
|
Number of Subjects With Global Response of Success at Endpoints
2 Wks post EOT
|
24 participants
|
|
Number of Subjects With Global Response of Success at Endpoints
6 Wks post EOT
|
17 participants
|
|
Number of Subjects With Global Response of Success at Endpoints
12 Wks post baseline
|
16 participants
|
SECONDARY outcome
Timeframe: EOIT, EOT (Day 5 up to Day 42), 2 Wks post EOT, 6 Wks post EOT, 12 Wks post baselinePopulation: MITT. EOT visit could occur anytime from Day 5 through Day 42; if a subject terminated early, the timeframe "at end of 12 weeks after baseline" could occur in the follow-up period (6 Wks post EOT or Week 12 post EOT).
Number of subjects with clinician assessed clinical response (CR) of success. Defined as cure or improvement (cure/improvement): cure=resolution of signs and symptoms of Candida infection; improvement=significant but incomplete resolution of signs and symptoms of Candida infection on the clinical response.
Outcome measures
| Measure |
Anidulafungin
n=42 Participants
Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
|
|---|---|
|
Number of Subjects With Clinical Response of Success at Endpoints
EOIT: success (cure/improvement)
|
34 participants
|
|
Number of Subjects With Clinical Response of Success at Endpoints
EOIT: cure
|
27 participants
|
|
Number of Subjects With Clinical Response of Success at Endpoints
EOIT: improvement
|
7 participants
|
|
Number of Subjects With Clinical Response of Success at Endpoints
EOT: success (cure/improvement)
|
32 participants
|
|
Number of Subjects With Clinical Response of Success at Endpoints
EOT: cure
|
27 participants
|
|
Number of Subjects With Clinical Response of Success at Endpoints
EOT: improvement
|
5 participants
|
|
Number of Subjects With Clinical Response of Success at Endpoints
2 Wks post EOT: success (cure/improvement)
|
26 participants
|
|
Number of Subjects With Clinical Response of Success at Endpoints
2 Wks post EOT: cure
|
25 participants
|
|
Number of Subjects With Clinical Response of Success at Endpoints
2 Wks post EOT: improvement
|
1 participants
|
|
Number of Subjects With Clinical Response of Success at Endpoints
6 Wks post EOT: success (cure/improvement)
|
17 participants
|
|
Number of Subjects With Clinical Response of Success at Endpoints
6 Wks post EOT: cure
|
16 participants
|
|
Number of Subjects With Clinical Response of Success at Endpoints
6 Wks post EOT: improvement
|
1 participants
|
|
Number of Subjects With Clinical Response of Success at Endpoints
12 Wks post baseline: success (cure/improvement)
|
17 participants
|
|
Number of Subjects With Clinical Response of Success at Endpoints
12 Wks post baseline: cure
|
17 participants
|
|
Number of Subjects With Clinical Response of Success at Endpoints
12 Wks post baseline: improvement
|
0 participants
|
SECONDARY outcome
Timeframe: EOIT, EOT (Day 5 up to Day 42), 2 Wks post EOT, 6 Wks post EOT, 12 Wks post baselinePopulation: MITT. EOT visit could occur anytime from Day 5 through Day 42; if a subject terminated early, the timeframe "at end of 12 weeks after baseline" could occur in the follow-up period (6 Wks post EOT or Week 12 post EOT).
Number of subjects with clinician assessed microbiological response (MR) of success. Defined as eradication or presumed eradication (erad/presumed erad): erad=follow up negative culture result for Candida spp; presumed eradication=follow up culture was not available and clinical outcome defined as success on the microbiological response.
Outcome measures
| Measure |
Anidulafungin
n=42 Participants
Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
|
|---|---|
|
Number of Subjects With Microbiological Response of Success at Endpoints
12 Wks post baseline: success (erad/presumed erad)
|
16 participants
|
|
Number of Subjects With Microbiological Response of Success at Endpoints
12 Wks post baseline: erad
|
14 participants
|
|
Number of Subjects With Microbiological Response of Success at Endpoints
12 Wks post baseline: presumed erad
|
2 participants
|
|
Number of Subjects With Microbiological Response of Success at Endpoints
EOIT: success (erad/presumed erad)
|
36 participants
|
|
Number of Subjects With Microbiological Response of Success at Endpoints
EOIT: erad
|
31 participants
|
|
Number of Subjects With Microbiological Response of Success at Endpoints
EOIT: presumed erad
|
5 participants
|
|
Number of Subjects With Microbiological Response of Success at Endpoints
EOT: success (erad/presumed erad)
|
34 participants
|
|
Number of Subjects With Microbiological Response of Success at Endpoints
EOT: erad
|
31 participants
|
|
Number of Subjects With Microbiological Response of Success at Endpoints
EOT: presumed erad
|
3 participants
|
|
Number of Subjects With Microbiological Response of Success at Endpoints
2 Wks post EOT: success (erad/presumed erad)
|
25 participants
|
|
Number of Subjects With Microbiological Response of Success at Endpoints
2 Wks post EOT: erad
|
22 participants
|
|
Number of Subjects With Microbiological Response of Success at Endpoints
2 Wks post EOT: presumed erad
|
3 participants
|
|
Number of Subjects With Microbiological Response of Success at Endpoints
6 Wks post EOT: success (erad/presumed erad)
|
17 participants
|
|
Number of Subjects With Microbiological Response of Success at Endpoints
6 Wks post EOT: erad
|
14 participants
|
|
Number of Subjects With Microbiological Response of Success at Endpoints
6 Wks post EOT: presumed erad
|
3 participants
|
SECONDARY outcome
Timeframe: Baseline through end of 12 weeks after baselinePopulation: MITT; time to death (median survival time in days) based on Kaplan-Meier method if estimable. Data not summarized by median survival time as planned as median time is not estimable; \< 50% of subjects died out of the analyzable population.
Time to death (median survival time in days) from any cause; time to death includes the first day (Day 1) of study drug (baseline and Day 1 allowed to occur on same day). EOT visit could occur anytime from Day 5 through Day 42; if a subject terminated early, the timeframe "at end of 12 weeks after baseline" could occur in the follow-up period (6 Wks post EOT or Week 12 post EOT).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through end of 12 weeks after baselinePopulation: MITT; time to death (median survival time in days) based on Kaplan-Meier method if estimable. Data not summarized by median survival time as planned as median time is not estimable; no subjects died due to candidemia out of the analyzable population.
Time to death (median survival time in days) due to candidemia; time to death includes the first day (Day 1) of study drug (baseline and Day 1 allowed to occur on same day). EOT visit could occur anytime from Day 5 through Day 42; if a subject terminated early, the timeframe "at end of 12 weeks after baseline" could occur in the follow-up period (6 Wks post EOT or Week 12 post EOT).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42)Population: MITT; (n)=number of subjects with analyzable data at observation; summary includes only subjects who completed visit; missing or indeterminate CR treated as failures. Failures were carried forward for subjects who withdrew prematurely from study with a documented failure. "All" category includes all subjects with success or failure at EOT.
Absolute values for β-D-glucan (range 0 to 6000 picograms per milliliter \[pg/mL\]) summarized at all timeframe endpoints by subject's at end of all treatment clinical response status of success (Success at EOT) or failure (Failure at EOT) and as combined status of all subjects (All at EOT). Success: cure (resolution of signs and symptoms of Candida infection) or improvement (significant but incomplete resolution of signs and symptoms); failure: no significant improvement in signs and symptoms or death due to Candida infection; subjects must have received at least 3 doses of anidulafungin.
Outcome measures
| Measure |
Anidulafungin
n=42 Participants
Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
|
|---|---|
|
Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment
All at EOT: EOT β-D-glucan (n=31)
|
1202.7 pg/mL
Standard Deviation 1541.02
|
|
Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment
Success at EOT: baseline β-D-glucan (n=30)
|
1095.8 pg/mL
Standard Deviation 968.52
|
|
Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment
Failure at EOT: baseline β-D-glucan (n=10)
|
1447.9 pg/mL
Standard Deviation 2178.27
|
|
Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment
All at EOT: baseline β-D-glucan (n=40)
|
1183.9 pg/mL
Standard Deviation 1347.71
|
|
Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment
Success at EOT: Day 3 β-D-glucan (n=32)
|
1132.0 pg/mL
Standard Deviation 1249.22
|
|
Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment
Failure at EOT: Day 3 β-D-glucan (n=4)
|
2753.3 pg/mL
Standard Deviation 3991.50
|
|
Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment
All at EOT: Day 3 β-D-glucan (n=36)
|
1312.1 pg/mL
Standard Deviation 1736.33
|
|
Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment
Success at EOT: Day 5 β-D-glucan (n=29)
|
1140.5 pg/mL
Standard Deviation 1149.22
|
|
Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment
Failure at EOT: Day 5 β-D-glucan (n=6)
|
2443.8 pg/mL
Standard Deviation 3987.38
|
|
Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment
All at EOT: Day 5 β-D-glucan (n=35)
|
1363.9 pg/mL
Standard Deviation 1916.80
|
|
Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment
Success at EOT: Day 7 β-D-glucan (n=24)
|
1190.8 pg/mL
Standard Deviation 1011.93
|
|
Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment
Failure at EOT: Day 7 β-D-glucan (n=4)
|
3140.8 pg/mL
Standard Deviation 4436.99
|
|
Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment
All at EOT: Day 7 β-D-glucan (n=28)
|
1469.4 pg/mL
Standard Deviation 1882.17
|
|
Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment
Success at EOT: EOT β-D-glucan (n=28)
|
1018.9 pg/mL
Standard Deviation 783.76
|
|
Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment
Failure at EOT: EOT β-D-glucan (n=3)
|
2917.7 pg/mL
Standard Deviation 4737.50
|
SECONDARY outcome
Timeframe: Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42)Population: MITT; (n)=number of subjects with analyzable data at observation; summary includes only subjects who completed visit; missing or indeterminate CR treated as failures. Failures were carried forward for subjects who withdrew prematurely from study with a documented failure. "All" category includes all subjects with success or failure at EOT.
Change from baseline for β-D-glucan (range 0 to 6000 pg/mL) summarized at endpoints by subject's at end of all treatment clinical response status of Success at EOT or Failure at EOT and as combined status of All at EOT. Success=cure (resolution of signs, symptoms of Candida infection) or improvement (significant but incomplete resolution of signs, symptoms); failure=no significant improvement or death due to Candida infection; subject must have received at least 3 doses of anidulafungin. Percent change calculated as (\[mean value of β-D-glucan at observation-baseline value\]/baseline value\*100).
Outcome measures
| Measure |
Anidulafungin
n=42 Participants
Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
|
|---|---|
|
Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment
Success at EOT: Day 3 β-D-glucan (n=30)
|
-0.4 percent change
Standard Deviation 50.56
|
|
Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment
Failure at EOT: Day 3 β-D-glucan (n=4)
|
-11.0 percent change
Standard Deviation 51.50
|
|
Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment
All at EOT: Day 3 β-D-glucan (n=34)
|
-1.7 percent change
Standard Deviation 49.99
|
|
Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment
Success at EOT: Day 5 β-D-glucan (n=27)
|
-1.0 percent change
Standard Deviation 52.14
|
|
Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment
Failure at EOT: Day 5 β-D-glucan (n=6)
|
1.3 percent change
Standard Deviation 54.36
|
|
Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment
All at EOT: Day 5 β-D-glucan (n=33)
|
-0.6 percent change
Standard Deviation 51.68
|
|
Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment
Success at EOT: Day 7 β-D-glucan (n=23)
|
4.3 percent change
Standard Deviation 55.37
|
|
Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment
Failure at EOT: Day 7 β-D-glucan (n=4)
|
4.5 percent change
Standard Deviation 24.14
|
|
Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment
All at EOT: Day 7 β-D-glucan (n=27)
|
4.3 percent change
Standard Deviation 51.59
|
|
Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment
Success at EOT: EOT β-D-glucan (n=27)
|
7.0 percent change
Standard Deviation 69.64
|
|
Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment
Failure at EOT: EOT β-D-glucan (n=3)
|
14.0 percent change
Standard Deviation 18.41
|
|
Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment
All at EOT: EOT β-D-glucan (n=30)
|
7.7 percent change
Standard Deviation 66.15
|
SECONDARY outcome
Timeframe: Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42)Population: MITT; (n)=number of subjects with analyzable data at observation; summary includes only subjects who completed visit; missing microbiological responses treated as failures. Failures carried forward for subjects who withdrew prematurely from study with documented failure. "All" category includes all subjects with success or failure at EOT.
Absolute values for β-D-glucan (range 0 to 6000 pg/mL) summarized at timeframe endpoints by subject's at end of all treatment microbiological response status of Success at EOT or Failure at EOT and as combined status of All at EOT. Success: eradication (follow up negative culture for Candida spp) or presumed eradication (follow up culture was not available and clinical outcome defined as success); failure: persistence (follow up culture was positive for at least 1 baseline Candida spp) or presumed persistence (follow up culture was not available and clinical outcome was defined as failure).
Outcome measures
| Measure |
Anidulafungin
n=42 Participants
Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
|
|---|---|
|
Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response Status of Success or Status of Failure at End of All Treatment
Success at EOT: baseline β-D-glucan (n=32)
|
1219.7 pg/mL
Standard Deviation 1491.27
|
|
Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response Status of Success or Status of Failure at End of All Treatment
Failure at EOT: baseline β-D-glucan (n=8)
|
1040.4 pg/mL
Standard Deviation 491.35
|
|
Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response Status of Success or Status of Failure at End of All Treatment
All at EOT: baseline β-D-glucan (n=40)
|
1183.9 pg/mL
Standard Deviation 1347.71
|
|
Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response Status of Success or Status of Failure at End of All Treatment
Success at EOT: Day 3 β-D-glucan (n=32)
|
1349.0 pg/mL
Standard Deviation 1826.61
|
|
Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response Status of Success or Status of Failure at End of All Treatment
Failure at EOT: Day 3 β-D-glucan (n=4)
|
1017.4 pg/mL
Standard Deviation 752.22
|
|
Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response Status of Success or Status of Failure at End of All Treatment
All at EOT: Day 3 β-D-glucan (n=36)
|
1312.1 pg/mL
Standard Deviation 1736.33
|
|
Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response Status of Success or Status of Failure at End of All Treatment
Success at EOT: Day 5 β-D-glucan (n=29)
|
1444.3 pg/mL
Standard Deviation 2087.84
|
|
Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response Status of Success or Status of Failure at End of All Treatment
Failure at EOT: Day 5 β-D-glucan (n=6)
|
975.3 pg/mL
Standard Deviation 595.29
|
|
Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response Status of Success or Status of Failure at End of All Treatment
All at EOT: Day 5 β-D-glucan (n=35)
|
1363.9 pg/mL
Standard Deviation 1916.80
|
|
Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response Status of Success or Status of Failure at End of All Treatment
Success at EOT: Day 7 β-D-glucan (n=24)
|
1527.2 pg/mL
Standard Deviation 2023.77
|
|
Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response Status of Success or Status of Failure at End of All Treatment
Failure at EOT: Day 7 β-D-glucan (n=4)
|
1122.3 pg/mL
Standard Deviation 544.01
|
|
Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response Status of Success or Status of Failure at End of All Treatment
All at EOT: Day 7 β-D-glucan (n=28)
|
1469.4 pg/mL
Standard Deviation 1882.17
|
|
Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response Status of Success or Status of Failure at End of All Treatment
Success at EOT: EOT β-D-glucan (n=31)
|
1202.7 pg/mL
Standard Deviation 1541.02
|
|
Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response Status of Success or Status of Failure at End of All Treatment
All at EOT: EOT β-D-glucan (n=31)
|
1202.7 pg/mL
Standard Deviation 1541.02
|
SECONDARY outcome
Timeframe: Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42)Population: MITT; (n)=number of subjects with analyzable data at observation; summary includes only subjects who completed visit; missing microbiological responses treated as failures. Failures carried forward for subjects who withdrew prematurely from study with documented failure. "All" category includes all subjects with success or failure at EOT.
Change from baseline in β-D-glucan (range 0 to 6000 pg/mL) summarized at endpoints and by subject's EOT microbiological response status of Success at EOT or Failure at EOT and as combined status of All at EOT. Success=eradication (negative culture Candida spp or presumed eradication (culture not available, clinical outcome defined as success); failure=persistence (culture positive for at least 1 baseline Candida spp) or presumed persistence (culture not available, clinical outcome defined as failure). Percent change=(\[mean value of β-D-glucan at observation-baseline value\]/baseline value\*100).
Outcome measures
| Measure |
Anidulafungin
n=42 Participants
Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
|
|---|---|
|
Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response of Status of Success or Status of Failure at EOT
Success at EOT: Day 3 β-D-glucan (n=30)
|
0.0 percent change
Standard Deviation 50.64
|
|
Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response of Status of Success or Status of Failure at EOT
Failure at EOT: Day 3 β-D-glucan (n=4)
|
-14.3 percent change
Standard Deviation 49.60
|
|
Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response of Status of Success or Status of Failure at EOT
All at EOT: Day 3 β-D-glucan (n=34)
|
-1.7 percent change
Standard Deviation 49.99
|
|
Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response of Status of Success or Status of Failure at EOT
Success at EOT: Day 5 β-D-glucan (n=27)
|
0.4 percent change
Standard Deviation 52.75
|
|
Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response of Status of Success or Status of Failure at EOT
Failure at EOT: Day 5 β-D-glucan (n=6)
|
-5.2 percent change
Standard Deviation 50.95
|
|
Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response of Status of Success or Status of Failure at EOT
All at EOT: Day 5 β-D-glucan (n=33)
|
-0.6 percent change
Standard Deviation 51.68
|
|
Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response of Status of Success or Status of Failure at EOT
Success at EOT: Day 7 β-D-glucan (n=23)
|
5.6 percent change
Standard Deviation 55.63
|
|
Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response of Status of Success or Status of Failure at EOT
Failure at EOT: Day 7 β-D-glucan (n=4)
|
-3.0 percent change
Standard Deviation 16.97
|
|
Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response of Status of Success or Status of Failure at EOT
All at EOT: Day 7 β-D-glucan (n=27)
|
4.3 percent change
Standard Deviation 51.59
|
|
Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response of Status of Success or Status of Failure at EOT
Success at EOT: EOT β-D-glucan (n=30)
|
7.7 percent change
Standard Deviation 66.15
|
|
Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response of Status of Success or Status of Failure at EOT
All at EOT: Day 7 β-D-glucan (n=30)
|
7.7 percent change
Standard Deviation 66.15
|
SECONDARY outcome
Timeframe: EOT (Day 5 up to Day 42)Population: MITT. May have \>1 baseline pathogen; previous surgery=any surgery (includes abdominal surgery) within 1 month prior to baseline (PTB); chemotherapy for solid cell tumors or hematological malignancies at baseline or within 3 months PTB; central venous catheter (CVC) up to 1 month PTB; (n)=subjects per subgroup with analyzable data at observation.
Number of subjects with clinician assessed global response of success at EOT (clinical=cure, improvement, microbiological=eradication, presumed eradication) in relation to subject subgroups (subject may be represented in \>1 subgroup). Subgroups: Neutropenic status (absolute neutrophil count \[ANC in cubic millimeters \[cmm\]); baseline pathogen; previous surgery (any surgery, abdominal surgery); organ transplantation (kidney, liver, heart); elderly; renal insufficiency (calculated creatinine clearance \[CCC\] in milliliters per minute \[mL/min\]); central venous catheter; receiving chemotherapy.
Outcome measures
| Measure |
Anidulafungin
n=42 Participants
Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
|
|---|---|
|
Number of Subjects With Global Response of Success at EOT in Relation to Subject Subgroups
Neutropenic status: ANC ≤ 500/cmm (n=2)
|
1 participants
|
|
Number of Subjects With Global Response of Success at EOT in Relation to Subject Subgroups
Neutropenic status: ANC >500/cmm (n=37)
|
28 participants
|
|
Number of Subjects With Global Response of Success at EOT in Relation to Subject Subgroups
Baseline pathogen: Candida albicans (n=14)
|
10 participants
|
|
Number of Subjects With Global Response of Success at EOT in Relation to Subject Subgroups
Baseline pathogen: Candida glabrata (n=6)
|
4 participants
|
|
Number of Subjects With Global Response of Success at EOT in Relation to Subject Subgroups
Baseline pathogen: Candida parapsilosis (n=4)
|
4 participants
|
|
Number of Subjects With Global Response of Success at EOT in Relation to Subject Subgroups
Baseline pathogen: Candida rugosa (n=1)
|
1 participants
|
|
Number of Subjects With Global Response of Success at EOT in Relation to Subject Subgroups
Baseline pathogen: Candida tropicalis (n=18)
|
13 participants
|
|
Number of Subjects With Global Response of Success at EOT in Relation to Subject Subgroups
Previous surgery: Any surgery (n=13)
|
11 participants
|
|
Number of Subjects With Global Response of Success at EOT in Relation to Subject Subgroups
Previous surgery: Abdominal surgery (n=8)
|
7 participants
|
|
Number of Subjects With Global Response of Success at EOT in Relation to Subject Subgroups
Elderly: Age ≥ 65 years (n=17)
|
10 participants
|
|
Number of Subjects With Global Response of Success at EOT in Relation to Subject Subgroups
Renal insufficiency (CCC < 30 mL/min) (n=11)
|
6 participants
|
|
Number of Subjects With Global Response of Success at EOT in Relation to Subject Subgroups
Use of Central venous catheter = Yes (n=21)
|
17 participants
|
|
Number of Subjects With Global Response of Success at EOT in Relation to Subject Subgroups
Receiving chemotherapy = Yes (n=7)
|
5 participants
|
Adverse Events
Anidulafungin
Serious adverse events
| Measure |
Anidulafungin
n=43 participants at risk
Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
|
|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
2.3%
1/43
|
|
Cardiac disorders
Cardio-respiratory arrest
|
2.3%
1/43
|
|
Cardiac disorders
Myocardial infarction
|
2.3%
1/43
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
2.3%
1/43
|
|
General disorders
Chills
|
2.3%
1/43
|
|
General disorders
Pyrexia
|
2.3%
1/43
|
|
Infections and infestations
Bacteraemia
|
2.3%
1/43
|
|
Infections and infestations
Pneumonia
|
2.3%
1/43
|
|
Infections and infestations
Septic shock
|
4.7%
2/43
|
|
Infections and infestations
Systemic candida
|
2.3%
1/43
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
2.3%
1/43
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.3%
1/43
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
2.3%
1/43
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
2.3%
1/43
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
2.3%
1/43
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
2.3%
1/43
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
2.3%
1/43
|
|
Nervous system disorders
Cerebrovascular accident
|
2.3%
1/43
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.3%
1/43
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.3%
1/43
|
|
Vascular disorders
Hypotension
|
2.3%
1/43
|
Other adverse events
| Measure |
Anidulafungin
n=43 participants at risk
Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
|
|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
4.7%
2/43
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.3%
1/43
|
|
Cardiac disorders
Acute coronary syndrome
|
2.3%
1/43
|
|
Cardiac disorders
Cardiac failure congestive
|
2.3%
1/43
|
|
Cardiac disorders
Tachycardia
|
4.7%
2/43
|
|
Eye disorders
Asthenopia
|
2.3%
1/43
|
|
Eye disorders
Conjunctivitis
|
2.3%
1/43
|
|
Gastrointestinal disorders
Abdominal pain
|
4.7%
2/43
|
|
Gastrointestinal disorders
Ascites
|
2.3%
1/43
|
|
Gastrointestinal disorders
Constipation
|
7.0%
3/43
|
|
Gastrointestinal disorders
Diarrhoea
|
18.6%
8/43
|
|
Gastrointestinal disorders
Flatulence
|
2.3%
1/43
|
|
Gastrointestinal disorders
Ileus
|
2.3%
1/43
|
|
Gastrointestinal disorders
Nausea
|
4.7%
2/43
|
|
Gastrointestinal disorders
Peritonitis
|
2.3%
1/43
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
4.7%
2/43
|
|
Gastrointestinal disorders
Vomiting
|
7.0%
3/43
|
|
General disorders
Chest discomfort
|
2.3%
1/43
|
|
General disorders
Chest pain
|
2.3%
1/43
|
|
General disorders
Oedema peripheral
|
4.7%
2/43
|
|
General disorders
Pain
|
4.7%
2/43
|
|
General disorders
Pitting oedema
|
4.7%
2/43
|
|
General disorders
Pyrexia
|
2.3%
1/43
|
|
General disorders
Thirst
|
2.3%
1/43
|
|
Hepatobiliary disorders
Jaundice
|
2.3%
1/43
|
|
Immune system disorders
Drug hypersensitivity
|
2.3%
1/43
|
|
Infections and infestations
Abscess limb
|
2.3%
1/43
|
|
Infections and infestations
Acarodermatitis
|
2.3%
1/43
|
|
Infections and infestations
Bacteraemia
|
4.7%
2/43
|
|
Infections and infestations
Bacterial sepsis
|
2.3%
1/43
|
|
Infections and infestations
Cellulitis
|
2.3%
1/43
|
|
Infections and infestations
Nasopharyngitis
|
2.3%
1/43
|
|
Infections and infestations
Nosocomial infection
|
2.3%
1/43
|
|
Infections and infestations
Oral candidiasis
|
7.0%
3/43
|
|
Infections and infestations
Pneumonia
|
2.3%
1/43
|
|
Infections and infestations
Sepsis
|
4.7%
2/43
|
|
Infections and infestations
Systemic candida
|
2.3%
1/43
|
|
Infections and infestations
Urosepsis
|
2.3%
1/43
|
|
Investigations
ECG signs of myocardial ischaemia
|
2.3%
1/43
|
|
Investigations
Transaminases increased
|
2.3%
1/43
|
|
Metabolism and nutrition disorders
Cachexia
|
2.3%
1/43
|
|
Metabolism and nutrition disorders
Dehydration
|
2.3%
1/43
|
|
Metabolism and nutrition disorders
Fluid overload
|
4.7%
2/43
|
|
Metabolism and nutrition disorders
Hyperammonaemia
|
2.3%
1/43
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.7%
2/43
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
4.7%
2/43
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
7.0%
3/43
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
2.3%
1/43
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.3%
1/43
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.6%
5/43
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
2.3%
1/43
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
2.3%
1/43
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.3%
1/43
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.3%
1/43
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.3%
1/43
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
2.3%
1/43
|
|
Nervous system disorders
Convulsion
|
2.3%
1/43
|
|
Nervous system disorders
Depressed level of consciousness
|
2.3%
1/43
|
|
Nervous system disorders
Hepatic encephalopathy
|
2.3%
1/43
|
|
Nervous system disorders
Somnolence
|
2.3%
1/43
|
|
Psychiatric disorders
Anxiety
|
4.7%
2/43
|
|
Psychiatric disorders
Confusional state
|
2.3%
1/43
|
|
Psychiatric disorders
Delirium
|
2.3%
1/43
|
|
Psychiatric disorders
Depression
|
2.3%
1/43
|
|
Psychiatric disorders
Insomnia
|
9.3%
4/43
|
|
Renal and urinary disorders
Azotaemia
|
2.3%
1/43
|
|
Renal and urinary disorders
Haematuria
|
2.3%
1/43
|
|
Renal and urinary disorders
Hydronephrosis
|
2.3%
1/43
|
|
Renal and urinary disorders
Renal failure acute
|
2.3%
1/43
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
4.7%
2/43
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
2.3%
1/43
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.7%
2/43
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.3%
1/43
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
2.3%
1/43
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.3%
1/43
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.3%
1/43
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract haemorrhage
|
2.3%
1/43
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.3%
1/43
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
2.3%
1/43
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.3%
1/43
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.0%
3/43
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
2.3%
1/43
|
|
Vascular disorders
Deep vein thrombosis
|
2.3%
1/43
|
|
Vascular disorders
Hypertension
|
2.3%
1/43
|
|
Vascular disorders
Hypotension
|
7.0%
3/43
|
|
Vascular disorders
Thrombophlebitis
|
2.3%
1/43
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \< 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER