Trial Outcomes & Findings for Caspofungin or Micafungin as Empiric Antifungal Therapy for Persistent Fever and Neutropenia (NCT NCT00723073)
NCT ID: NCT00723073
Last Updated: 2010-08-31
Results Overview
Overall favorable response was defined as achievement of successful treatment of baseline fungal infections, survival to hospital discharge, absence of breakthrough Ivasive fungal disese (IFD), and lack of advserse events (AE) attributable to treatment that led to discontinuation of echinocandin therapy.
Recruitment status
COMPLETED
Target enrollment
323 participants
Primary outcome timeframe
11/1/2005 - 10/31/2007
Results posted on
2010-08-31
Participant Flow
Participant milestones
| Measure |
Caspofungin Arm
All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC \< 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
|
Micafungin Arm
All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC \< 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
|
|---|---|---|
|
Overall Study
STARTED
|
149
|
174
|
|
Overall Study
COMPLETED
|
149
|
174
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Caspofungin or Micafungin as Empiric Antifungal Therapy for Persistent Fever and Neutropenia
Baseline characteristics by cohort
| Measure |
Caspofungin Arm
n=149 Participants
All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC \< 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
|
Micafungin Arm
n=174 Participants
All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC \< 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
|
Total
n=323 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
49 years
n=5 Participants
|
49 years
n=7 Participants
|
49 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
80 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
179 Participants
n=5 Participants
|
|
Primary Underlying Disease
Acute myelogenous leukemia
|
76 participants
n=5 Participants
|
82 participants
n=7 Participants
|
158 participants
n=5 Participants
|
|
Primary Underlying Disease
Non-Hodgkin's lymphoma
|
28 participants
n=5 Participants
|
25 participants
n=7 Participants
|
53 participants
n=5 Participants
|
|
Primary Underlying Disease
Acute lymphoblastic leukemia
|
9 participants
n=5 Participants
|
20 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Primary Underlying Disease
Hodgkin's lymphoma
|
8 participants
n=5 Participants
|
12 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Primary Underlying Disease
Chronic myelogenous leukemia
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Primary Underlying Disease
Multiple myeloma
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Primary Underlying Disease
Myelodysplastic syndrome
|
5 participants
n=5 Participants
|
7 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Primary Underlying Disease
Aplastic anemia
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Primary Underlying Disease
other onocological diagnosis
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
hematopoietic stem cell transplantation status
Hematopoietic stem cell transplantation
|
81 participants
n=5 Participants
|
108 participants
n=7 Participants
|
189 participants
n=5 Participants
|
|
hematopoietic stem cell transplantation status
No - Hematopoietic stem cell transplantation
|
68 participants
n=5 Participants
|
66 participants
n=7 Participants
|
134 participants
n=5 Participants
|
|
Patient Weight, kg
|
80 kilograms
n=5 Participants
|
80 kilograms
n=7 Participants
|
80 kilograms
n=5 Participants
|
PRIMARY outcome
Timeframe: 11/1/2005 - 10/31/2007Overall favorable response was defined as achievement of successful treatment of baseline fungal infections, survival to hospital discharge, absence of breakthrough Ivasive fungal disese (IFD), and lack of advserse events (AE) attributable to treatment that led to discontinuation of echinocandin therapy.
Outcome measures
| Measure |
Caspofungin Arm
n=149 Participants
All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC \< 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
|
Micafungin Arm
n=174 Participants
All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC \< 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
|
|---|---|---|
|
Composite Primary Endpoint: Number of Participants With an Overall Favorable Response to Echinocandin Therapy for Empiric Antifungal Therapy for Persistent Febrile Neutropenia (FN)
Yes
|
122 participants
|
141 participants
|
|
Composite Primary Endpoint: Number of Participants With an Overall Favorable Response to Echinocandin Therapy for Empiric Antifungal Therapy for Persistent Febrile Neutropenia (FN)
No
|
27 participants
|
33 participants
|
PRIMARY outcome
Timeframe: 11/1/2005 - 10/31/2007Possible or proven baseline invasive fungal disease were defined as were diagnosed within the 2 days of initiating echinocandin therapy for persistent febrile neutropenia
Outcome measures
| Measure |
Caspofungin Arm
n=149 Participants
All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC \< 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
|
Micafungin Arm
n=174 Participants
All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC \< 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
|
|---|---|---|
|
Successful Treatment of Any Baseline Invasive Fungal Disease (IFD)
No Baseline IFD
|
146 participants
|
168 participants
|
|
Successful Treatment of Any Baseline Invasive Fungal Disease (IFD)
Successfully treated baseline IFD
|
2 participants
|
4 participants
|
|
Successful Treatment of Any Baseline Invasive Fungal Disease (IFD)
Unsuccessfully treated baseline IFD
|
1 participants
|
2 participants
|
PRIMARY outcome
Timeframe: 11/1/2005 - 10/31/2007We assessed all patients in the study cohort who dischaged from the hospital alive
Outcome measures
| Measure |
Caspofungin Arm
n=149 Participants
All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC \< 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
|
Micafungin Arm
n=174 Participants
All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC \< 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
|
|---|---|---|
|
Mortality at Hospital Discharge
Alive at hospital discharge
|
137 participants
|
161 participants
|
|
Mortality at Hospital Discharge
Died before hospitial discharge
|
12 participants
|
13 participants
|
PRIMARY outcome
Timeframe: 11/1/2005 - 10/31/2007a breakthrough invasive fungal disesase was defined as any fungal infection that was diagnosed \> 3 days on or during therapy or within 7 days after completion of therapy with an echinocandin
Outcome measures
| Measure |
Caspofungin Arm
n=149 Participants
All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC \< 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
|
Micafungin Arm
n=174 Participants
All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC \< 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
|
|---|---|---|
|
Absence of Any Breakthrough Invasive Fungal Disease (IFD)
No breakthrough IFD
|
133 participants
|
153 participants
|
|
Absence of Any Breakthrough Invasive Fungal Disease (IFD)
Breakthrough IFD
|
16 participants
|
21 participants
|
PRIMARY outcome
Timeframe: 11/1/2005 - 10/31/2007Defined as any advsere event directly attributable to echinocandin treatment that led to discontinuation of therapy or switch to alternative therapy
Outcome measures
| Measure |
Caspofungin Arm
n=149 Participants
All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC \< 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
|
Micafungin Arm
n=174 Participants
All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC \< 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
|
|---|---|---|
|
Lack of an Adverse Drug Event (ADE) Attributable to Echinocandin (EC) Therapy That Led to Discontinuation of Therapy
No ADE
|
146 participants
|
172 participants
|
|
Lack of an Adverse Drug Event (ADE) Attributable to Echinocandin (EC) Therapy That Led to Discontinuation of Therapy
ADE which caused EC therapy discontinuation
|
3 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 11/1/2005 - 10/31/2007median duration of therapy with an echinocandin (caspofungin or micafungin) for persistent febrile neutropenia (FN)
Outcome measures
| Measure |
Caspofungin Arm
n=149 Participants
All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC \< 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
|
Micafungin Arm
n=174 Participants
All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC \< 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
|
|---|---|---|
|
Duration of Echinocadin Therapy for Persistent Febrile Neutropenia (FN)
|
10 days
Interval 6.0 to 18.0
|
9 days
Interval 6.0 to 16.0
|
SECONDARY outcome
Timeframe: 11/1/2005 - 10/31/2007aspartate aminotransferase (AST) or alanine aminotransferase (ALT)\> 5x the upper limit of normal (ULN) or total bilirubin \> 3x the upper limit of normal (ULN)
Outcome measures
| Measure |
Caspofungin Arm
n=149 Participants
All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC \< 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
|
Micafungin Arm
n=174 Participants
All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC \< 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
|
|---|---|---|
|
Liver Function Tests (LFTs) Elevated During or After Echinocandin Therapy
No LFT elevations
|
110 participants
|
132 participants
|
|
Liver Function Tests (LFTs) Elevated During or After Echinocandin Therapy
AST > 5x upper limit of normal
|
14 participants
|
15 participants
|
|
Liver Function Tests (LFTs) Elevated During or After Echinocandin Therapy
ALT > 5x upper limit of normal
|
10 participants
|
9 participants
|
|
Liver Function Tests (LFTs) Elevated During or After Echinocandin Therapy
Total Bilirubin >3x upper limit of normal
|
15 participants
|
18 participants
|
SECONDARY outcome
Timeframe: 11/1/2005 - 10/31/2007The description of the adverse event that resulted in discontinuation of echinocandin (EC) therapy
Outcome measures
| Measure |
Caspofungin Arm
n=149 Participants
All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC \< 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
|
Micafungin Arm
n=174 Participants
All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC \< 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
|
|---|---|---|
|
Specific Type of Adverse Event That Resulted in Echinocandin (EC) Therapy Discontinuation
No Adverse Event requiring EC discontinuation
|
146 participants
|
172 participants
|
|
Specific Type of Adverse Event That Resulted in Echinocandin (EC) Therapy Discontinuation
Rash
|
2 participants
|
1 participants
|
|
Specific Type of Adverse Event That Resulted in Echinocandin (EC) Therapy Discontinuation
Liver function Test (LFT) increase
|
0 participants
|
1 participants
|
|
Specific Type of Adverse Event That Resulted in Echinocandin (EC) Therapy Discontinuation
Anaphylaxis
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 11/1/2005 - 10/31/2007Median number of days patients were hospitalized during the study period
Outcome measures
| Measure |
Caspofungin Arm
n=149 Participants
All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC \< 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
|
Micafungin Arm
n=174 Participants
All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC \< 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
|
|---|---|---|
|
Duration of Hospitization
|
29 days
Interval 24.0 to 38.0
|
28 days
Interval 23.0 to 38.0
|
SECONDARY outcome
Timeframe: 11/1/2005 - 10/31/2007Median number of days patients were neutropenic during the study period
Outcome measures
| Measure |
Caspofungin Arm
n=149 Participants
All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC \< 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
|
Micafungin Arm
n=174 Participants
All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC \< 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
|
|---|---|---|
|
Duration of Neutropenia
|
20 days
Interval 13.0 to 30.0
|
17 days
Interval 13.0 to 28.0
|
Adverse Events
Caspofungin Arm
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
Micafungin Arm
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Caspofungin Arm
n=149 participants at risk
All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC \< 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
|
Micafungin Arm
n=174 participants at risk
All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC \< 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
1.3%
2/149 • Number of events 2
|
0.57%
1/174 • Number of events 1
|
|
Hepatobiliary disorders
Liver function test elevation
|
0.00%
0/149
|
0.57%
1/174 • Number of events 1
|
|
Immune system disorders
Anaphylaxis
|
0.67%
1/149 • Number of events 1
|
0.00%
0/174
|
Other adverse events
| Measure |
Caspofungin Arm
n=149 participants at risk
All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC \< 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
|
Micafungin Arm
n=174 participants at risk
All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC \< 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
|
|---|---|---|
|
Hepatobiliary disorders
AST > 5x ULN
|
9.4%
14/149 • Number of events 14
|
8.6%
15/174 • Number of events 15
|
|
Hepatobiliary disorders
ALT > 5x ULN
|
6.7%
10/149 • Number of events 10
|
5.2%
9/174 • Number of events 9
|
|
Hepatobiliary disorders
Total Bilirubin > 3x ULN
|
6.7%
10/149 • Number of events 15
|
10.3%
18/174 • Number of events 18
|
Additional Information
David Kubiak, Principle Investigator
Brigham and Women's Hospital
Phone: 617-525-8417
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place