search
Back to results

This Is An Open-Label, Non-Comparative Study Designed To Evaluate A Short Course Of IV Anidulafungin, Followed Optionally By Oral Voriconazole, For The Treatment Of Candidemia And Invasive Candidiasis

Primary Purpose

Candidemia, Invasive Candidiasis

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Anidulafungin
Voriconazole
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Candidemia focused on measuring Open-label, non-comparative study to evaluate short course of IV anidulafungin, followed by oral voriconazole, for tx of candidemia/invasive candidiasis.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female patient 18 years of age and older.
  • If female, must be post-menopausal, surgically sterile or using adequate contraception,not lactating, and have a negative urine or blood pregnancy test at screening, prior to administration of study medication.
  • Presence of candidemia (positive blood culture) or invasive candidiasis (histopathologic or cytopathologic examination of a needle aspiration or biopsy specimen from a normally sterile site excluding mucous membranes showing yeast cells) obtained within the prior 96 hours to study entry ((informed consent provided).
  • Presence of one or more of the following signs and symptoms of acute fungal infection within the prior 48 hours to initiation of study treatment:

    • Fever defined as oral temperature greater than or equal to 38 degrees C (100.4 degrees F); rectal or core temperature greater than or equal to 38.6 degrees C (101.4 degrees F), or axillary temperature greater than or equal to 37.5 degrees Celsius (99.5 degrees F). Hypothermia defined as rectal or core temperature less than 36.0 degrees C (96.8 degrees F).
    • Hypotension (systolic blood pressure [SBP] less than 100 mmHg, or SBP decrease greater than or equal to 30 mm Hg from baseline.
    • Localized signs and symptoms of inflammation (swelling, heat, erythema or purulence at a site infected with Candida spp.).
  • Patient is classified in one of following categories based on previous antifungal treatment: received less than 48 hours of previous systemic antifungal therapy and no more than a single dose of echinocandin therapy prior to study entry; intolerant to infusion related toxicities of amphotericin B preparations despite appropriate supportive measures or serum creatinine increased by >1.5 mg/dl while receiving conventional or lipid amphotericin B therapy; or lack of clinical response and/or persistent positive blood culture after at least seven days of systemic antifungal treatment with a polyene or fluconazole at an adequate dose.
  • APACHE II 9 score < 25 at study entry.
  • Patients willing and able to give informed consent, or have a legally authorized representative willing to give informed consent on the patients behalf.
  • Expected survival (in the opinion of the investigator) greater than 4 days.

Exclusion Criteria:

  • Hypersensitivity to anidulafungin, other echinocandins or azoles.
  • Participation presently or within the last 30 days in a trial with other investigational drug(s). Patients on antiretroviral or chemotherapy regimens which include an investigational drug may participate provided that there has been no change in their therapy during the past 4 weeks and no change in treatment is anticipated during study participation.
  • Chronic refractory neutropenia defined as absolute neutrophils count <500 cells/mm3 for 28 days prior to the baseline visit.
  • Confirmed or suspected Candida osteomyelitis, endocarditis or meningitis.
  • Poor venous access that would preclude IV drug delivery or multiple blood draws.
  • Prosthetic devices at a suspected site of infection unless the device is removed within 24 hours of study entry.
  • Fungal endophthalmitis confirmed by fundoscopy.
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration that may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the Patient inappropriate for entry into this trial.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants for Global Response (Based on Clinical and Microbiological Success or Failure) at End of Treatment
Clinical Success (cure=resolution of Candida signs and symptoms [s/s] or improvement=significant but incomplete resolution of s/s) or Failure (at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological Success (eradication=negative culture for baseline Candida species (spp) or presumed eradication=follow-up (f/u) culture not available (n/a) and clinical outcome defined as success) or Failure (persistence=positive culture for at least 1 baseline Candida spp or presumed persistence=f/u culture n/a and clinical outcome defined as failure).

Secondary Outcome Measures

Number of Participants for Global Response (Based on Clinical and Microbiological Success or Failure)
Clinical Success (cure=resolution of Candida signs and symptoms [s/s] or improvement=significant but incomplete resolution of s/s) or Failure (at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological Success (eradication=negative culture for baseline Candida species (spp) or presumed eradication=follow-up (f/u) culture not available (n/a) and clinical outcome defined as success) or Failure (persistence=positive culture for at least 1 baseline Candida spp or presumed persistence=f/u culture n/a and clinical outcome defined as failure).
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT
Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Categorized as global Success if both clinical and microbiological response=success; Failure defined as all other combinations. Global response at EIVT was assessed per the type of Candida species that was isolated at the baseline visit.
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT
Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Categorized as global Success if both clinical and microbiological response=success; Failure defined as all other combinations. Global response at EOT was assessed per the type of Candida species that was isolated at the baseline visit.
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up
Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Categorized as global Success if both clinical and microbiological response=success; Failure defined as all other combinations. Global response at Week 2 Follow-up was assessed per the type of Candida species that was isolated at the baseline visit.
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT
Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Global response at EOT was assessed for participants categorized with baseline risk factors (Yes or No status) for Intensive Care Unit (ICU) stay ≥ 4 days, mechanical ventilation, broad spectrum antibiotics (antibiotics), central venous (CV) catheter, total parental nutrition (TPN), dialysis, abdominal surgery, solid organ transplant, renal insufficiency, chemotherapy, pancreatitis, systemic steroids or immunosuppressives (Systemic steroids/immunos), neutropenic status, or elderly.
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT
Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Global response at EIVT was assessed for participants categorized with baseline risk factors for Candidemia and Invasive Candidiasis: ICU stay ≥ 4 days, mechanical ventilation, broad spectrum antibiotics (antibiotics), central venous (CV) catheter, total parental nutrition (TPN), dialysis, abdominal surgery, solid organ transplant, renal insufficiency, chemotherapy, pancreatitis, systemic steroids or immunosuppressives (Systemic steroids/immunos), neutropenic status, or elderly.
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up
Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Global response at Week 2 F/U was assessed for participants categorized with baseline risk factors for Candidemia and Invasive Candidiasis: ICU stay ≥ 4 days, mechanical ventilation, broad spectrum antibiotics (antibiotics), central venous (CV) catheter, total parental nutrition (TPN), dialysis, abdominal surgery, solid organ transplant, renal insufficiency, chemotherapy, pancreatitis, systemic steroids or immunosuppressives (Systemic steroids/immunos), neutropenic status, or elderly.
Number of Participants for Global Response by Acute Physiological Assessment and Chronic Health Evaluation II (APACHE II) Score
Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Categorized as global Success if both clinical and microbiological response=success; Failure defined as all other combinations. Global response assessed as APACHE II score <20 (less affected) or ≥20 (more severe). APACHE II assesses severity of illness in acutely ill participants; measurements computed for physiologic variables were transformed to integer score ranging 0 (normal) to 71 (more severe). Higher scores indicate more severe disease and higher risk of death.
Number of Participants Per Survival Status (Alive or Dead) on Day 30
Number of Participants With Death Attributable (Yes or No) to Candidemia or Invasive Candidiasis
Death is attributable to Candidemia or Invasive Candidiasis if investigator recorded "disease under study" as cause of death. Candidemia (positive blood culture) or Invasive Cadidiasis (yeast cells in histopathological or cytopathological exam). Week 6 Follow-up visit conducted by phone.
Time to Negative Blood, Specimen, or Tissue Culture
Defined as time from first drug administratin to date of earliest recorded documentation of negative blood, specimen, or tissue culture (absence of Candidemia or Invasive Candidiasis). Candidemia (positive blood culture) or Invasive Cadidiasis (yeast cells in histopathological or cytopathological exam).
Duration of Exposure to Intravenous Anidulafungin Prior to Switch to Oral Voriconazole Treatment
Defined as time in days from first intravenous administration of Anidulafungin to the date of earliest recorded documentation of switch to oral Voriconazole treatment. Participants received at least 5 days (and a maximum of 42 days) of IV Anidulafungin; after this, they may continue treatment with oral Voriconazole for at least 14 days from the day of last positive culture up to a maximum of 42 days.
Length of Hospital Stay
Defined as the number of days from date of first drug administration to date of first hospital discharge if participant was discharged to home or other location. Week 6 Follow-up visit conducted by phone.
Length of Stay in Intensive Care Unit (ICU)
Defined as the number of days from date of first drug administration to date of first ICU discharge. Week 6 Follow-up visit conducted by phone.
Change From Baseline in Vital Signs: Supine Blood Pressure
Supine systolic and diastolic blood pressure BP) measured as millimeters of mercury (mmHg).
Change From Baseline in Vital Signs: Supine Heart Rate
Supine heart rate measured as beats per minute (bpm).
Change From Baseline in Vital Signs: Weight
Weight measured as kilograms (kg).
Change From Baseline in Vital Signs: Temperature
Temperature measured as degrees of Celsius (C).
Change From Baseline in Vital Signs: Respiration Rate
Respiration rate measured as respirations per minute (resp/min).
Change From Baseline in Chemistry Laboratory Test Data (Measured as mg/dL)
Chemistry laboratory test data measured as milligrams per deciliter (mg/dL).
Change From Baseline in Chemistry Laboratory Test Data (Measured as IU/L)
Chemistry laboratory test data measured as international units per (IU/L).

Full Information

First Posted
October 19, 2007
Last Updated
December 15, 2010
Sponsor
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT00548262
Brief Title
This Is An Open-Label, Non-Comparative Study Designed To Evaluate A Short Course Of IV Anidulafungin, Followed Optionally By Oral Voriconazole, For The Treatment Of Candidemia And Invasive Candidiasis
Official Title
Open-Label, Non-Comparative, Study Of Intravenous Anidulafungin, Followed Optionally By Oral Voriconazole, For Treatment Of Documented Candidemia/Invasive Candidiasis In Hospitalized Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective is to estimate global response rate. Clinical, microbiological and global response rates and its 95% confidence intervals will be computed. No hypotheses will be tested.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candidemia, Invasive Candidiasis
Keywords
Open-label, non-comparative study to evaluate short course of IV anidulafungin, followed by oral voriconazole, for tx of candidemia/invasive candidiasis.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Anidulafungin
Other Intervention Name(s)
Eraxis
Intervention Description
All patients will receive anidulafungin 200 mg IV dose on Day 1. On Day 2 and daily thereafter the patients will receive one daily IV dose of 100 mg of anidulafungin.
Intervention Type
Drug
Intervention Name(s)
Voriconazole
Other Intervention Name(s)
Vfend
Intervention Description
Patients who complete a minimum of 5 days of IV treatment with anidulafungin may be switched to oral voriconazole 200 mg BID (or 100 mg BID if <40 kg body weight) therapy on Day 5 and thereafter, starting with a loading dose of 400 mg BID (or 200 mg BID if <40 kg body weight).
Primary Outcome Measure Information:
Title
Number of Participants for Global Response (Based on Clinical and Microbiological Success or Failure) at End of Treatment
Description
Clinical Success (cure=resolution of Candida signs and symptoms [s/s] or improvement=significant but incomplete resolution of s/s) or Failure (at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological Success (eradication=negative culture for baseline Candida species (spp) or presumed eradication=follow-up (f/u) culture not available (n/a) and clinical outcome defined as success) or Failure (persistence=positive culture for at least 1 baseline Candida spp or presumed persistence=f/u culture n/a and clinical outcome defined as failure).
Time Frame
End of Treatment (EOT) (up to Day 42)
Secondary Outcome Measure Information:
Title
Number of Participants for Global Response (Based on Clinical and Microbiological Success or Failure)
Description
Clinical Success (cure=resolution of Candida signs and symptoms [s/s] or improvement=significant but incomplete resolution of s/s) or Failure (at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological Success (eradication=negative culture for baseline Candida species (spp) or presumed eradication=follow-up (f/u) culture not available (n/a) and clinical outcome defined as success) or Failure (persistence=positive culture for at least 1 baseline Candida spp or presumed persistence=f/u culture n/a and clinical outcome defined as failure).
Time Frame
End of Intravenous Treatment (EIVT) (up to Day 42), Week 2 Follow-up
Title
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT
Description
Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Categorized as global Success if both clinical and microbiological response=success; Failure defined as all other combinations. Global response at EIVT was assessed per the type of Candida species that was isolated at the baseline visit.
Time Frame
Baseline, EIVT (up to Day 42)
Title
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT
Description
Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Categorized as global Success if both clinical and microbiological response=success; Failure defined as all other combinations. Global response at EOT was assessed per the type of Candida species that was isolated at the baseline visit.
Time Frame
Baseline, EOT (up to Day 42)
Title
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up
Description
Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Categorized as global Success if both clinical and microbiological response=success; Failure defined as all other combinations. Global response at Week 2 Follow-up was assessed per the type of Candida species that was isolated at the baseline visit.
Time Frame
Baseline, Week 2 Follow-up
Title
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT
Description
Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Global response at EOT was assessed for participants categorized with baseline risk factors (Yes or No status) for Intensive Care Unit (ICU) stay ≥ 4 days, mechanical ventilation, broad spectrum antibiotics (antibiotics), central venous (CV) catheter, total parental nutrition (TPN), dialysis, abdominal surgery, solid organ transplant, renal insufficiency, chemotherapy, pancreatitis, systemic steroids or immunosuppressives (Systemic steroids/immunos), neutropenic status, or elderly.
Time Frame
Baseline, EOT (up to Day 42)
Title
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT
Description
Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Global response at EIVT was assessed for participants categorized with baseline risk factors for Candidemia and Invasive Candidiasis: ICU stay ≥ 4 days, mechanical ventilation, broad spectrum antibiotics (antibiotics), central venous (CV) catheter, total parental nutrition (TPN), dialysis, abdominal surgery, solid organ transplant, renal insufficiency, chemotherapy, pancreatitis, systemic steroids or immunosuppressives (Systemic steroids/immunos), neutropenic status, or elderly.
Time Frame
EIVT (up to Day 42)
Title
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up
Description
Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Global response at Week 2 F/U was assessed for participants categorized with baseline risk factors for Candidemia and Invasive Candidiasis: ICU stay ≥ 4 days, mechanical ventilation, broad spectrum antibiotics (antibiotics), central venous (CV) catheter, total parental nutrition (TPN), dialysis, abdominal surgery, solid organ transplant, renal insufficiency, chemotherapy, pancreatitis, systemic steroids or immunosuppressives (Systemic steroids/immunos), neutropenic status, or elderly.
Time Frame
Baseline, Week 2 Follow-up (F/U)
Title
Number of Participants for Global Response by Acute Physiological Assessment and Chronic Health Evaluation II (APACHE II) Score
Description
Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Categorized as global Success if both clinical and microbiological response=success; Failure defined as all other combinations. Global response assessed as APACHE II score <20 (less affected) or ≥20 (more severe). APACHE II assesses severity of illness in acutely ill participants; measurements computed for physiologic variables were transformed to integer score ranging 0 (normal) to 71 (more severe). Higher scores indicate more severe disease and higher risk of death.
Time Frame
EIVT (up to Day 42), EOT (up to Day 42), Week 2 Follow-up
Title
Number of Participants Per Survival Status (Alive or Dead) on Day 30
Time Frame
Day 30
Title
Number of Participants With Death Attributable (Yes or No) to Candidemia or Invasive Candidiasis
Description
Death is attributable to Candidemia or Invasive Candidiasis if investigator recorded "disease under study" as cause of death. Candidemia (positive blood culture) or Invasive Cadidiasis (yeast cells in histopathological or cytopathological exam). Week 6 Follow-up visit conducted by phone.
Time Frame
Baseline to Week 6 Follow-up
Title
Time to Negative Blood, Specimen, or Tissue Culture
Description
Defined as time from first drug administratin to date of earliest recorded documentation of negative blood, specimen, or tissue culture (absence of Candidemia or Invasive Candidiasis). Candidemia (positive blood culture) or Invasive Cadidiasis (yeast cells in histopathological or cytopathological exam).
Time Frame
Baseline to Week 2 Follow-up
Title
Duration of Exposure to Intravenous Anidulafungin Prior to Switch to Oral Voriconazole Treatment
Description
Defined as time in days from first intravenous administration of Anidulafungin to the date of earliest recorded documentation of switch to oral Voriconazole treatment. Participants received at least 5 days (and a maximum of 42 days) of IV Anidulafungin; after this, they may continue treatment with oral Voriconazole for at least 14 days from the day of last positive culture up to a maximum of 42 days.
Time Frame
Baseline to Day 42
Title
Length of Hospital Stay
Description
Defined as the number of days from date of first drug administration to date of first hospital discharge if participant was discharged to home or other location. Week 6 Follow-up visit conducted by phone.
Time Frame
Baseline to Week 6 Follow-up
Title
Length of Stay in Intensive Care Unit (ICU)
Description
Defined as the number of days from date of first drug administration to date of first ICU discharge. Week 6 Follow-up visit conducted by phone.
Time Frame
Baseline up to Week 6 Follow-up
Title
Change From Baseline in Vital Signs: Supine Blood Pressure
Description
Supine systolic and diastolic blood pressure BP) measured as millimeters of mercury (mmHg).
Time Frame
Baseline to Week 2 Follow-up
Title
Change From Baseline in Vital Signs: Supine Heart Rate
Description
Supine heart rate measured as beats per minute (bpm).
Time Frame
Baseline to Week 2 Follow-up
Title
Change From Baseline in Vital Signs: Weight
Description
Weight measured as kilograms (kg).
Time Frame
Baseline to Week 2 Follow-up
Title
Change From Baseline in Vital Signs: Temperature
Description
Temperature measured as degrees of Celsius (C).
Time Frame
Baseline to Week 2 Follow-up
Title
Change From Baseline in Vital Signs: Respiration Rate
Description
Respiration rate measured as respirations per minute (resp/min).
Time Frame
Baseline to Week 2 Follow-up
Title
Change From Baseline in Chemistry Laboratory Test Data (Measured as mg/dL)
Description
Chemistry laboratory test data measured as milligrams per deciliter (mg/dL).
Time Frame
Baseline to Week 2 Follow-up
Title
Change From Baseline in Chemistry Laboratory Test Data (Measured as IU/L)
Description
Chemistry laboratory test data measured as international units per (IU/L).
Time Frame
Baseline to Week 2 Follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female patient 18 years of age and older. If female, must be post-menopausal, surgically sterile or using adequate contraception,not lactating, and have a negative urine or blood pregnancy test at screening, prior to administration of study medication. Presence of candidemia (positive blood culture) or invasive candidiasis (histopathologic or cytopathologic examination of a needle aspiration or biopsy specimen from a normally sterile site excluding mucous membranes showing yeast cells) obtained within the prior 96 hours to study entry ((informed consent provided). Presence of one or more of the following signs and symptoms of acute fungal infection within the prior 48 hours to initiation of study treatment: Fever defined as oral temperature greater than or equal to 38 degrees C (100.4 degrees F); rectal or core temperature greater than or equal to 38.6 degrees C (101.4 degrees F), or axillary temperature greater than or equal to 37.5 degrees Celsius (99.5 degrees F). Hypothermia defined as rectal or core temperature less than 36.0 degrees C (96.8 degrees F). Hypotension (systolic blood pressure [SBP] less than 100 mmHg, or SBP decrease greater than or equal to 30 mm Hg from baseline. Localized signs and symptoms of inflammation (swelling, heat, erythema or purulence at a site infected with Candida spp.). Patient is classified in one of following categories based on previous antifungal treatment: received less than 48 hours of previous systemic antifungal therapy and no more than a single dose of echinocandin therapy prior to study entry; intolerant to infusion related toxicities of amphotericin B preparations despite appropriate supportive measures or serum creatinine increased by >1.5 mg/dl while receiving conventional or lipid amphotericin B therapy; or lack of clinical response and/or persistent positive blood culture after at least seven days of systemic antifungal treatment with a polyene or fluconazole at an adequate dose. APACHE II 9 score < 25 at study entry. Patients willing and able to give informed consent, or have a legally authorized representative willing to give informed consent on the patients behalf. Expected survival (in the opinion of the investigator) greater than 4 days. Exclusion Criteria: Hypersensitivity to anidulafungin, other echinocandins or azoles. Participation presently or within the last 30 days in a trial with other investigational drug(s). Patients on antiretroviral or chemotherapy regimens which include an investigational drug may participate provided that there has been no change in their therapy during the past 4 weeks and no change in treatment is anticipated during study participation. Chronic refractory neutropenia defined as absolute neutrophils count <500 cells/mm3 for 28 days prior to the baseline visit. Confirmed or suspected Candida osteomyelitis, endocarditis or meningitis. Poor venous access that would preclude IV drug delivery or multiple blood draws. Prosthetic devices at a suspected site of infection unless the device is removed within 24 hours of study entry. Fungal endophthalmitis confirmed by fundoscopy. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration that may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the Patient inappropriate for entry into this trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Brasilia
State/Province
DF
ZIP/Postal Code
70710-905
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Curitiba
State/Province
PR
ZIP/Postal Code
80060-900
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
21941-913
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90020-090
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90110-270
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Sao Jose do Rio Preto
State/Province
SP
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Independencia
State/Province
Santiago, RM
ZIP/Postal Code
8380456
Country
Chile
Facility Name
Pfizer Investigational Site
City
Bogota DC
State/Province
Cundinamarca
ZIP/Postal Code
0000
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
0000
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Leon
State/Province
Guanajuato
ZIP/Postal Code
37320
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Pfizer Investigational Site
City
San Luis Potosi
ZIP/Postal Code
78240
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Panama
Country
Panama

12. IPD Sharing Statement

Citations:
PubMed Identifier
33891293
Citation
De Rosa FG, Busca A, Capparella MR, Yan JL, Aram JA. Invasive Candidiasis in Patients with Solid Tumors Treated with Anidulafungin: A Post Hoc Analysis of Efficacy and Safety of Six Pooled Studies. Clin Drug Investig. 2021 Jun;41(6):539-548. doi: 10.1007/s40261-021-01024-7. Epub 2021 Apr 23.
Results Reference
derived
PubMed Identifier
31280481
Citation
Sganga G, Wang M, Capparella MR, Tawadrous M, Yan JL, Aram JA, Montravers P. Evaluation of anidulafungin in the treatment of intra-abdominal candidiasis: a pooled analysis of patient-level data from 5 prospective studies. Eur J Clin Microbiol Infect Dis. 2019 Oct;38(10):1849-1856. doi: 10.1007/s10096-019-03617-9. Epub 2019 Jul 6.
Results Reference
derived
PubMed Identifier
28597967
Citation
Kontoyiannis DP, Bassetti M, Nucci M, Capparella MR, Yan JL, Aram J, Hogan PA. Anidulafungin for the treatment of candidaemia caused by Candida parapsilosis: Analysis of pooled data from six prospective clinical studies. Mycoses. 2017 Oct;60(10):663-667. doi: 10.1111/myc.12641. Epub 2017 Jun 9.
Results Reference
derived
PubMed Identifier
28459966
Citation
Kullberg BJ, Vasquez J, Mootsikapun P, Nucci M, Paiva JA, Garbino J, Yan JL, Aram J, Capparella MR, Conte U, Schlamm H, Swanson R, Herbrecht R. Efficacy of anidulafungin in 539 patients with invasive candidiasis: a patient-level pooled analysis of six clinical trials. J Antimicrob Chemother. 2017 Aug 1;72(8):2368-2377. doi: 10.1093/jac/dkx116.
Results Reference
derived
PubMed Identifier
23710653
Citation
Nucci M, Colombo AL, Petti M, Magana M, Abreu P, Schlamm HT, Sanchez SP. An open-label study of anidulafungin for the treatment of candidaemia/invasive candidiasis in Latin America. Mycoses. 2014 Jan;57(1):12-8. doi: 10.1111/myc.12094. Epub 2013 May 26.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A8851015&StudyName=This%20Is%20An%20Open-Label%2C%20Non-Comparative%20Study%20Designed%20To%20Evaluate%20A%20Short%20Course%20Of%20IV%20Anidulafungin%2C%20Followed%20Optionally%20By%20Oral%20Vo
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

This Is An Open-Label, Non-Comparative Study Designed To Evaluate A Short Course Of IV Anidulafungin, Followed Optionally By Oral Voriconazole, For The Treatment Of Candidemia And Invasive Candidiasis

We'll reach out to this number within 24 hrs