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The purpose of this study is to describe the real world effectiveness of anidulafungin in clinical practice in a large Liver Unit in the United Kingdom.
All subjects that have been treated with Anidulafungin according to its licence during the period of July 2009 and September 2010 will be included.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anidulafungin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anidulafungin | Drug | A single 200 mg loading dose should be administered on Day 1, followed by 100 mg daily thereafter. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Favorable Outcome | Favorable outcome was defined as favorable clinical response and documented or presumed microbial eradication (two negative follow-up blood cultures for bloodstream infections or a successful clinical response without follow-up cultures for other infections). Favorable clinical response was defined as clinical resolution of signs and symptoms of infection and no need to change or add to antifungal therapy, or transition to oral antifungal to complete therapy. | Day 28 post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Unfavorable Outcome | Unfavorable outcome was defined as the need to change to another antifungal agent because of lack of clinical response or death due to the antifungal infection or microbiologic persistence of the fungus or superinfection with a new Candida, Aspergillus or other fungal strain occurring at least 3 days and up to 14 days of anidulafungin therapy, or a lack of follow up data about clinical and microbiologic responses at the end of anidulafungin therapy. |
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Inclusion Criteria:
Patients admitted to specialist liver unit wards and the Liver Intensive Therapy Unit during this period
Exclusion Criteria:
Patients who received anidulafungin for infection prophylaxis
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Subjects admitted with candidiasis infections to the Liver Unit at King's College Hospital (United Kingdom) who are prescribed anidulafungin.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | London | SE5 9RS | United Kingdom |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Anidulafungin | Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Anidulafungin | Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Favorable Outcome | Favorable outcome was defined as favorable clinical response and documented or presumed microbial eradication (two negative follow-up blood cultures for bloodstream infections or a successful clinical response without follow-up cultures for other infections). Favorable clinical response was defined as clinical resolution of signs and symptoms of infection and no need to change or add to antifungal therapy, or transition to oral antifungal to complete therapy. | Full analysis set included all participants who met the defined eligibility criteria. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 28 post-treatment |
|
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Anidulafungin | Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| New Candida parapsilosis infection | General disorders | No coding system | Non-systematic Assessment |
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Protocol-specified endpoint, percentage of participants with presumed eradication of infecting species, was not presented as a separate outcome measure because the 'presumed eradication' was considered same as favorable clinical response.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D002177 | Candidiasis |
| C536972 | Torulopsis |
| D058387 | Candidemia |
| C536777 | Systemic candidiasis |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D058365 | Candidiasis, Invasive |
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| ID | Term |
|---|---|
| D000077612 | Anidulafungin |
| ID | Term |
|---|---|
| D054714 | Echinocandins |
| D010456 | Peptides, Cyclic |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Day 28 post-treatment |
| Percentage of Participants Who Died Due to All Causes | Death due to all causes included death attributable to fungal infection, death unrelated to fungal infection and death due to multiple causes. | Baseline up to Day 28 post-treatment |
| Percentage of Participants With Death Attributable to Fungal Infection | Baseline up to Day 28 post-treatment |
| Percentage of Participants With Death Unrelated to Fungal Infection | Baseline up to Day 28 post-treatment |
| Percentage of Participants With Favorable Clinical Response | Favorable clinical response was defined as clinical resolution of signs and symptoms of infection and no need to change or add to antifungal therapy, or transition to oral antifungal to complete therapy. | Day 28 post-treatment |
| Percentage of Participants With Lack of Clinical Response | Favorable clinical response was defined as clinical resolution of signs and symptoms of infection and no need to change or add to antifungal therapy, or transition to oral antifungal to complete therapy. | Day 28 post-treatment |
| Percentage of Participants Requiring Change or Additional Antifungal Therapy | Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100). | Baseline up to Day 28 post-treatment |
| Percentage of Participants With Oral Antifungal Started to Complete Therapy | Baseline up to Day 28 post-treatment |
| Percentage of Participants With Documented Eradication of Infecting Species | Documented microbial eradication was defined as 2 negative follow-up blood cultures for bloodstream infections. | Baseline |
| Percentage of Participants With Resolution of Signs of Infection According to Ultrasound Scan Results | An ultrasound scan was performed and the resultant scan was reviewed for the presence of the infection as per investigator's discretion. | Baseline up to Day 28 post-treatment |
| Percentage of Participants With Resolution of Signs of Infection According to Computerized Tomography (CT) Scan Results | A CT scan was performed and the resultant scan was reviewed for the presence of the infection as per investigator's discretion. | Baseline up to Day 28 post-treatment |
| Percentage of Participants With Abnormal Results for Liver Function at Initiation of Drug Therapy | Percentage of participants with abnormal liver function results were based on 4 liver function variables- bilirubin, aspartate transaminase, alkaline phosphatase and gamma glutamyl transferase. Normal reference ranges of these variables are: plasma bilirubin: 3-17 micromoles/L or 2.5-10 mg/L for adults; aspartate transaminase: 6-34 International Units/Liter (IU/L) for females and 8-40 IU/L for males; alkaline phosphatase: 5-38 IU/L for females and 10-50 IU/L for males; gamma glutamyl transferase: 7-32 IU/L for females and 11-50 IU/L for males. Upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100 by standard calculations (outside the valid range of 0 to 100). | Baseline |
| Percentage of Participants With Abnormal Results for Liver Function at End of Drug Therapy | Percentage of participants with abnormal liver function results were based on 4 liver function variables- bilirubin, aspartate transaminase, alkaline phosphatase and gamma glutamyl transferase. Normal reference ranges of these variables are: plasma bilirubin: 3-17 micromoles/L or 2.5-10 mg/L for adults; aspartate transaminase: 6-34 IU/L for females and 8-40 IU/L for males; alkaline phosphatase: 5-38 IU/L for females and 10-50 IU/L for males; gamma glutamyl transferase: 7-32 IU/L for females and 11-50 IU/L for males. | Day 28 post-treatment |
| Percentage of Participants With Liver Function Test Results at Least Twice the Baseline Value During Period of Drug Therapy | Percentage of participants with liver function test results at least twice the baseline value during period of drug therapy was calculated for the liver function variables, bilirubin, aspartate transaminase, alkaline phosphatase and gamma glutamyl transferase. | Baseline up to Day 28 post-treatment |
| Percentage of Participants With Creatinine Clearance at Least Twice the Baseline Value During Period of Drug Therapy | Baseline up to Day 28 post-treatment |
| Percentage of Participants Admitted to Liver Intensive Therapy Unit (LITU) | Baseline |
| Duration of Stay at Liver Intensive Therapy Unit (LITU) | Baseline up to Day 28 post-treatment |
| Percentage of Participants With Absolute Neutrophil Count Less Than 500 Per Cubic Millimeter (/mm^3) and Greater Than or Equal to 500 /mm^3 | Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 and upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100, by standard calculations (outside the valid range of 0 to 100). | Baseline |
| Percentage of Participants With Concomitant Bacterial or Viral Infection | Upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100 by standard calculations (outside the valid range of 0 to 100). | Baseline |
| Percentage of Participants Prescribed With Systemic Antifungal Within 30 Days Before Study Start | Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100). | Baseline |
| Dose Changes for Immunosuppressant Drugs | Baseline up to Day 28 post-treatment |
| Percentage of Participants With Probable or Proven Fungal Infection at the Initiation of Drug Therapy | Baseline |
| Percentage of Participants With Documented Body Temperature Above 38.0 Degree Celsius or Below 36.0 Degree Celsius Within 24 Hour Period Prior to Initiation of Drug Therapy | Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 and upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100, by standard calculations (outside the valid range of 0 to 100). | Baseline |
| Percentage of Participants With Systolic Blood Pressure More Than 2 Standard Deviations Below the Mean for Age Recorded Within 24 Hour Period Prior to Initiation of Drug Therapy | Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100). | Baseline |
| Number of Participants With Infection Sites as Per Microbiological Analysis | Infection sites included blood, chest, urinary tract, intra-abdominal, bile duct, liver, kidney, mouth and esophagus. | Baseline |
| Number of Participants With Infection Sites as Per Ultrasound Scan and Computerized Tomography (CT) Scan | Baseline |
| Infecting Organisms by Species | Baseline up to Day 14 post-treatment |
| Percentage of Participants With Prior Colonization With Candida by Species | Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100). | Baseline |
| Percentage of Participants With Prior Colonization With Candida by Colonization Index | Baseline |
| Percentage of Participants With Other Prior Fungal Infection by Species and Colonization Index | Baseline |
| Number of Participants Who Received Water-based and Ethanol-based Formulation | Baseline |
| Percentage of Participants Who Received Water-based and Ethanol-based Formulation | Baseline |
| Percentage of Participants Who Received 200 mg Loading Dose | Day 1 |
| Percentage of Participants Who Received 100 mg Dose on Day 2 | Day 2 |
| Percentage of Participants Who Received 200 mg Dose on Day 1 and 100 mg for All Subsequent Doses | Baseline up to Day 28 post-treatment |
| Number of Participants With Other Dosing Patterns | The other dosing patterns for anidulafungin included any dosing pattern different from 200 mg loading dose on Day 1 followed by 100 mg doses subsequently starting from Day 2. | Baseline up to Day 28 post-treatment |
| Duration of Anidulafungin Therapy | Baseline |
| Number of Serious Adverse Events (SAEs) | Any untoward medical occurrence in a participant who received study treatment was considered an adverse event (AE) without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Baseline up to Day 28 post-treatment |
| Percentage of Participants With One or More Drug-related Serious Adverse Events (SAEs) | Baseline up to Day 28 post-treatment |
| Number of Participants With Different Types of Drug-related Serious Adverse Events | Baseline up to Day 28 post-treatment |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Percentage of participants with elective or emergency hospital admission | Number | percentage of participants |
|
| Overall duration of hospital stay | Mean | Inter-Quartile Range | days |
|
| Number of participants with underlying liver disease | Number | participants |
|
| Number of participants with relevant co-morbidities | Other co-morbidities included renal failure or impairment, multi-organ failure, previous liver transplants, liver abscess and hepatic artery thrombosis. | Number | participants |
|
| Number of participants with markers of illness severity | Number | participants |
|
| Percentage of participants with Model for End-Stage Liver Disease (MELD) score | MELD is a scoring system for assessing the severity of chronic liver disease. MELD uses the participant's values for serum bilirubin, serum creatinine, and the INR for prothrombin time to predict survival. In interpreting the MELD score in hospitalized participants, the 3 month mortality is: greater than or equal to 40 - 71.3% mortality; 30-39 - 52.6% mortality; 20-29 - 19.6% mortality; 10-19 - 6.0% mortality; less than 10 - 1.9% mortality. | Number | percentage of participants |
|
| Number of participants with disease severity score | Disease severity score was based on acute physiological assessment and chronic health evaluation (APACHE), used for assessing severity of illness in acutely ill participants in intensive care units (ICUs). Total possible score range: 0 to 71 where higher score represented higher predicted mortality. | Number | participants |
|
| Number of participants with total white cell count | Number | participants |
|
| Number of participants with International Normalized Ratio (INR) results | Prothrombin time is a measure of the extrinsic pathway of coagulation that is used to determine the clotting tendency of blood. INR is the ratio of a participant's prothrombin time to a normal (control) sample. | Number | participants |
|
| Number of participants with C-reactive protein (CRP) levels | CRP levels were categorized either less than 5 mg/L and greater than or equal to 5 mg/L. Those participants with CRP levels not analyzed were reported under 'not done' category. | Number | participants |
|
| Number of participants with urea levels | Number | participants |
|
| Percentage of participants with creatinine clearance outside normal range | Normal values for creatinine clearance for an adult are below 80 milliliter/minute (mL/min). | Number | percentage of participants |
|
| Percentage of participants prescribed with immunosuppressant drugs | Number | percentage of participants |
|
| Percentage of participants prescribed with concomitant systemic antifungals | Number | percentage of participants |
|
| Percentage of participants prescribed with concomitant antibiotics | Number | percentage of participants |
|
| Number of participants with concomitant antibiotics prescribed | Participants were categorized into 6 categories, 0 to 5 based on the number of concomitant antibiotics prescribed to them. | Number | participants |
|
| Duration of antibiotic course | Median | Inter-Quartile Range | days |
|
| Percentage of participants prescribed with antiviral courses | Number | percentage of participants |
|
| Duration of antiviral courses | Median | Inter-Quartile Range | days |
|
|
|
| Secondary | Percentage of Participants With Unfavorable Outcome | Unfavorable outcome was defined as the need to change to another antifungal agent because of lack of clinical response or death due to the antifungal infection or microbiologic persistence of the fungus or superinfection with a new Candida, Aspergillus or other fungal strain occurring at least 3 days and up to 14 days of anidulafungin therapy, or a lack of follow up data about clinical and microbiologic responses at the end of anidulafungin therapy. | Full analysis set included all participants who met the defined eligibility criteria. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 28 post-treatment |
|
|
|
| Secondary | Percentage of Participants Who Died Due to All Causes | Death due to all causes included death attributable to fungal infection, death unrelated to fungal infection and death due to multiple causes. | Full analysis set included all participants who met the defined eligibility criteria. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to Day 28 post-treatment |
|
|
|
| Secondary | Percentage of Participants With Death Attributable to Fungal Infection | Full analysis set included all participants who met the defined eligibility criteria. | Posted | Number | percentage of participants | Baseline up to Day 28 post-treatment |
|
|
|
| Secondary | Percentage of Participants With Death Unrelated to Fungal Infection | Full analysis set included all participants who met the defined eligibility criteria. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to Day 28 post-treatment |
|
|
|
| Secondary | Percentage of Participants With Favorable Clinical Response | Favorable clinical response was defined as clinical resolution of signs and symptoms of infection and no need to change or add to antifungal therapy, or transition to oral antifungal to complete therapy. | Full analysis set included all participants who met the defined eligibility criteria. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 28 post-treatment |
|
|
|
| Secondary | Percentage of Participants With Lack of Clinical Response | Favorable clinical response was defined as clinical resolution of signs and symptoms of infection and no need to change or add to antifungal therapy, or transition to oral antifungal to complete therapy. | Full analysis set included all participants who met the defined eligibility criteria. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 28 post-treatment |
|
|
|
| Secondary | Percentage of Participants Requiring Change or Additional Antifungal Therapy | Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100). | Full analysis set included all participants who met the defined eligibility criteria. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to Day 28 post-treatment |
|
|
|
| Secondary | Percentage of Participants With Oral Antifungal Started to Complete Therapy | Full analysis set included all participants who met the defined eligibility criteria. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to Day 28 post-treatment |
|
|
|
| Secondary | Percentage of Participants With Documented Eradication of Infecting Species | Documented microbial eradication was defined as 2 negative follow-up blood cultures for bloodstream infections. | Data was not analyzed as the study was retrospective and data for eradication of candida infection was not documented in the participants' medical notes. | Posted | Baseline |
|
|
| Secondary | Percentage of Participants With Resolution of Signs of Infection According to Ultrasound Scan Results | An ultrasound scan was performed and the resultant scan was reviewed for the presence of the infection as per investigator's discretion. | Full analysis set included all participants who met the defined eligibility criteria. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to Day 28 post-treatment |
|
|
|
| Secondary | Percentage of Participants With Resolution of Signs of Infection According to Computerized Tomography (CT) Scan Results | A CT scan was performed and the resultant scan was reviewed for the presence of the infection as per investigator's discretion. | Full analysis set included all participants who met the defined eligibility criteria. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to Day 28 post-treatment |
|
|
|
| Secondary | Percentage of Participants With Abnormal Results for Liver Function at Initiation of Drug Therapy | Percentage of participants with abnormal liver function results were based on 4 liver function variables- bilirubin, aspartate transaminase, alkaline phosphatase and gamma glutamyl transferase. Normal reference ranges of these variables are: plasma bilirubin: 3-17 micromoles/L or 2.5-10 mg/L for adults; aspartate transaminase: 6-34 International Units/Liter (IU/L) for females and 8-40 IU/L for males; alkaline phosphatase: 5-38 IU/L for females and 10-50 IU/L for males; gamma glutamyl transferase: 7-32 IU/L for females and 11-50 IU/L for males. Upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100 by standard calculations (outside the valid range of 0 to 100). | Full analysis set included all participants who met the defined eligibility criteria. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline |
|
|
|
| Secondary | Percentage of Participants With Abnormal Results for Liver Function at End of Drug Therapy | Percentage of participants with abnormal liver function results were based on 4 liver function variables- bilirubin, aspartate transaminase, alkaline phosphatase and gamma glutamyl transferase. Normal reference ranges of these variables are: plasma bilirubin: 3-17 micromoles/L or 2.5-10 mg/L for adults; aspartate transaminase: 6-34 IU/L for females and 8-40 IU/L for males; alkaline phosphatase: 5-38 IU/L for females and 10-50 IU/L for males; gamma glutamyl transferase: 7-32 IU/L for females and 11-50 IU/L for males. | Full analysis set included all participants who met the defined eligibility criteria. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 28 post-treatment |
|
|
|
| Secondary | Percentage of Participants With Liver Function Test Results at Least Twice the Baseline Value During Period of Drug Therapy | Percentage of participants with liver function test results at least twice the baseline value during period of drug therapy was calculated for the liver function variables, bilirubin, aspartate transaminase, alkaline phosphatase and gamma glutamyl transferase. | Full analysis set included all participants who met the defined eligibility criteria. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to Day 28 post-treatment |
|
|
|
| Secondary | Percentage of Participants With Creatinine Clearance at Least Twice the Baseline Value During Period of Drug Therapy | Data was not analyzed as the study was retrospective and data for creatinine clearance was not available for the participants. | Posted | Baseline up to Day 28 post-treatment |
|
|
| Secondary | Percentage of Participants Admitted to Liver Intensive Therapy Unit (LITU) | Full analysis set included all participants who met the defined eligibility criteria. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline |
|
|
|
| Secondary | Duration of Stay at Liver Intensive Therapy Unit (LITU) | Full analysis set included all participants who met the defined eligibility criteria. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Mean | Inter-Quartile Range | days | Baseline up to Day 28 post-treatment |
|
|
|
| Secondary | Percentage of Participants With Absolute Neutrophil Count Less Than 500 Per Cubic Millimeter (/mm^3) and Greater Than or Equal to 500 /mm^3 | Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 and upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100, by standard calculations (outside the valid range of 0 to 100). | Full analysis set included all participants who met the defined eligibility criteria. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline |
|
|
|
| Secondary | Percentage of Participants With Concomitant Bacterial or Viral Infection | Upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100 by standard calculations (outside the valid range of 0 to 100). | Full analysis set included all participants who met the defined eligibility criteria. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline |
|
|
|
| Secondary | Percentage of Participants Prescribed With Systemic Antifungal Within 30 Days Before Study Start | Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100). | Full analysis set included all participants who met the defined eligibility criteria. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline |
|
|
|
| Secondary | Dose Changes for Immunosuppressant Drugs | Data was not analyzed as the study was retrospective and data for dose change for immunosuppressant drugs was not available. | Posted | Baseline up to Day 28 post-treatment |
|
|
| Secondary | Percentage of Participants With Probable or Proven Fungal Infection at the Initiation of Drug Therapy | Full analysis set included all participants who met the defined eligibility criteria. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline |
|
|
|
| Secondary | Percentage of Participants With Documented Body Temperature Above 38.0 Degree Celsius or Below 36.0 Degree Celsius Within 24 Hour Period Prior to Initiation of Drug Therapy | Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 and upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100, by standard calculations (outside the valid range of 0 to 100). | Full analysis set included all participants who met the defined eligibility criteria. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline |
|
|
|
| Secondary | Percentage of Participants With Systolic Blood Pressure More Than 2 Standard Deviations Below the Mean for Age Recorded Within 24 Hour Period Prior to Initiation of Drug Therapy | Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100). | Full analysis set included all participants who met the defined eligibility criteria. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline |
|
|
|
| Secondary | Number of Participants With Infection Sites as Per Microbiological Analysis | Infection sites included blood, chest, urinary tract, intra-abdominal, bile duct, liver, kidney, mouth and esophagus. | Full analysis set included all participants who met the defined eligibility criteria. | Posted | Number | participants | Baseline |
|
|
|
| Secondary | Number of Participants With Infection Sites as Per Ultrasound Scan and Computerized Tomography (CT) Scan | Data was not analyzed as the study was retrospective and data for infection site as per ultrasound and CT scan was not available. | Posted | Baseline |
|
|
| Secondary | Infecting Organisms by Species | Full analysis set included all participants who met the defined eligibility criteria. | Posted | Number | participants | Baseline up to Day 14 post-treatment |
|
|
|
| Secondary | Percentage of Participants With Prior Colonization With Candida by Species | Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100). | Full analysis set included all participants who met the defined eligibility criteria. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline |
|
|
|
| Secondary | Percentage of Participants With Prior Colonization With Candida by Colonization Index | Data for prior colonization by colonization index was not analyzed as the study was retrospective and colonization index was not recorded for the participants. | Posted | Baseline |
|
|
| Secondary | Percentage of Participants With Other Prior Fungal Infection by Species and Colonization Index | Full analysis set included all participants who met the defined eligibility criteria. | Posted | Number | percentage of participants | Baseline |
|
|
|
| Secondary | Number of Participants Who Received Water-based and Ethanol-based Formulation | Full analysis set included all participants who met the defined eligibility criteria. | Posted | Number | participants | Baseline |
|
|
|
| Secondary | Percentage of Participants Who Received Water-based and Ethanol-based Formulation | Full analysis set included all participants who met the defined eligibility criteria. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline |
|
|
|
| Secondary | Percentage of Participants Who Received 200 mg Loading Dose | Full analysis set included all participants who met the defined eligibility criteria. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1 |
|
|
|
| Secondary | Percentage of Participants Who Received 100 mg Dose on Day 2 | Full analysis set included all participants who met the defined eligibility criteria. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 2 |
|
|
|
| Secondary | Percentage of Participants Who Received 200 mg Dose on Day 1 and 100 mg for All Subsequent Doses | Full analysis set included all participants who met the defined eligibility criteria. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to Day 28 post-treatment |
|
|
|
| Secondary | Number of Participants With Other Dosing Patterns | The other dosing patterns for anidulafungin included any dosing pattern different from 200 mg loading dose on Day 1 followed by 100 mg doses subsequently starting from Day 2. | Full analysis set included all participants who met the defined eligibility criteria. | Posted | Number | participants | Baseline up to Day 28 post-treatment |
|
|
|
| Secondary | Duration of Anidulafungin Therapy | Full analysis set included all participants who met the defined eligibility criteria. | Posted | Mean | Standard Deviation | days | Baseline |
|
|
|
| Secondary | Number of Serious Adverse Events (SAEs) | Any untoward medical occurrence in a participant who received study treatment was considered an adverse event (AE) without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Full analysis set included all participants who met the defined eligibility criteria. | Posted | Number | events | Baseline up to Day 28 post-treatment |
|
|
|
| Secondary | Percentage of Participants With One or More Drug-related Serious Adverse Events (SAEs) | Full analysis set included all participants who met the defined eligibility criteria. | Posted | Number | percentage of participants | Baseline up to Day 28 post-treatment |
|
|
|
| Secondary | Number of Participants With Different Types of Drug-related Serious Adverse Events | Full analysis set included all participants who met the defined eligibility criteria. | Posted | Number | participants | Baseline up to Day 28 post-treatment |
|
|
|
| 5 |
| 50 |
| 0 |
| 50 |
| Breakthrough Candida glabrata infection | General disorders | No coding system | Non-systematic Assessment |
|
| Breakthrough Candida parapsilosis infection | General disorders | No coding system | Non-systematic Assessment |
|
| Continuing Candida glabrata infection | General disorders | No coding system | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D000072742 |
| Invasive Fungal Infections |
| D016469 | Fungemia |
| D018805 | Sepsis |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
|
|
| Gamma glutamyl transferase test |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Chest only |
|
| Intra-abdominal |
|
| Intra-abdominal and bile duct |
|
| Intra-abdominal and blood |
|
| Intra-abdominal, chest and liver |
|
| Intra-abdominal and kidney |
|
| Intra-abdominal and liver |
|
| Liver only |
|
| Liver and urinary tract |
|
| Esophagus and mouth |
|
| Urinary tract and chest |
|
| Urinary tract and esophagus |
|
| Candida krusei |
|
| Candida parapsilosis |
|
| Candida species (spp) |
|
| Candida spp (non Candida albicans) |
|
| Candida tropicalis |
|
| Fusarium dimerum |
|
| Saccharomyces cerevisiae |
|
| Yeast |
|
| Adenovirus |
|
| Citrobacter |
|
| Clostridium difficile |
|
| Cytomegalovirus (CMV) |
|
| Escherichia coli |
|
| Escherichia faecalis |
|
| Escherichia faecium |
|
| Epstein-Barr virus (EBV) |
|
| Elizabeth meningoseptica cum chrysobacterium |
|
| Enterobacter cloacae |
|
| Enterobacter spp |
|
| Hemagglutinin 1 Neuraminidase 1 (H1N1)- swine flu |
|
| Herpes simplex virus type 1 |
|
| Klebsiella oxytoca |
|
| Klebsiella pneumonia |
|
| Klebsiella spp |
|
| Methicillin-resistent Staphylococcus aureus |
|
| Pneumocystic jiroveci |
|
| Pseudomonas spp |
|
| Respiratory syncytial virus |
|
| Rhinovirus |
|
| Staphylococcus aureus |
|
| Staphylococcus capitis |
|
| Stenotrophomonas maltophilia |
|
| Stenotrophomonas spp |
|
| Vancomycin-resistant enterococcus |
|
| Pseudomonas aeruginosa |
|
| Staphylococcus epidermidis |
|
| Title | Measurements |
|---|---|
|
| Candida spp |
|
| Candida tropicalis |
|
| Candida species unknown |
|