- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00548262
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
December 15, 2010 updated by: Pfizer
Open-Label, Non-Comparative, Study Of Intravenous Anidulafungin, Followed Optionally By Oral Voriconazole, For Treatment Of Documented Candidemia/Invasive Candidiasis In Hospitalized Patients
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
DF
-
Brasilia, DF, Brazil, 70710-905
- Pfizer Investigational Site
-
-
PR
-
Curitiba, PR, Brazil, 80060-900
- Pfizer Investigational Site
-
-
RJ
-
Rio de Janeiro, RJ, Brazil, 21941-913
- Pfizer Investigational Site
-
-
RS
-
Porto Alegre, RS, Brazil, 90020-090
- Pfizer Investigational Site
-
Porto Alegre, RS, Brazil, 90110-270
- Pfizer Investigational Site
-
-
SP
-
Sao Jose do Rio Preto, SP, Brazil, 15090-000
- Pfizer Investigational Site
-
-
-
-
Santiago, RM
-
Independencia, Santiago, RM, Chile, 8380456
- Pfizer Investigational Site
-
-
-
-
Cundinamarca
-
Bogota DC, Cundinamarca, Colombia, 0000
- Pfizer Investigational Site
-
-
Valle Del Cauca
-
Cali, Valle Del Cauca, Colombia, 0000
- Pfizer Investigational Site
-
-
-
-
-
San Luis Potosi, Mexico, 78240
- Pfizer Investigational Site
-
-
Guanajuato
-
Leon, Guanajuato, Mexico, 37320
- Pfizer Investigational Site
-
-
Jalisco
-
Guadalajara, Jalisco, Mexico, 44280
- Pfizer Investigational Site
-
-
-
-
-
Panama, Panama
- Pfizer Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
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.
Other Names:
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).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants for Global Response (Based on Clinical and Microbiological Success or Failure) at End of Treatment
Time Frame: End of Treatment (EOT) (up to Day 42)
|
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).
|
End of Treatment (EOT) (up to Day 42)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants for Global Response (Based on Clinical and Microbiological Success or Failure)
Time Frame: End of Intravenous Treatment (EIVT) (up to Day 42), Week 2 Follow-up
|
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).
|
End of Intravenous Treatment (EIVT) (up to Day 42), Week 2 Follow-up
|
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT
Time Frame: Baseline, EIVT (up to Day 42)
|
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.
|
Baseline, EIVT (up to Day 42)
|
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT
Time Frame: Baseline, EOT (up to Day 42)
|
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.
|
Baseline, EOT (up to Day 42)
|
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up
Time Frame: 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.
|
Baseline, Week 2 Follow-up
|
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT
Time Frame: Baseline, EOT (up to Day 42)
|
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.
|
Baseline, EOT (up to Day 42)
|
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT
Time Frame: EIVT (up to Day 42)
|
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.
|
EIVT (up to Day 42)
|
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up
Time Frame: Baseline, Week 2 Follow-up (F/U)
|
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.
|
Baseline, Week 2 Follow-up (F/U)
|
Number of Participants for Global Response by Acute Physiological Assessment and Chronic Health Evaluation II (APACHE II) Score
Time Frame: EIVT (up to Day 42), EOT (up to Day 42), 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 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.
|
EIVT (up to Day 42), EOT (up to Day 42), Week 2 Follow-up
|
Number of Participants Per Survival Status (Alive or Dead) on Day 30
Time Frame: Day 30
|
Day 30
|
|
Number of Participants With Death Attributable (Yes or No) to Candidemia or Invasive Candidiasis
Time Frame: Baseline to Week 6 Follow-up
|
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.
|
Baseline to Week 6 Follow-up
|
Time to Negative Blood, Specimen, or Tissue Culture
Time Frame: Baseline to Week 2 Follow-up
|
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).
|
Baseline to Week 2 Follow-up
|
Duration of Exposure to Intravenous Anidulafungin Prior to Switch to Oral Voriconazole Treatment
Time Frame: Baseline to Day 42
|
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.
|
Baseline to Day 42
|
Length of Hospital Stay
Time Frame: Baseline to Week 6 Follow-up
|
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.
|
Baseline to Week 6 Follow-up
|
Length of Stay in Intensive Care Unit (ICU)
Time Frame: Baseline up to Week 6 Follow-up
|
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.
|
Baseline up to Week 6 Follow-up
|
Change From Baseline in Vital Signs: Supine Blood Pressure
Time Frame: Baseline to Week 2 Follow-up
|
Supine systolic and diastolic blood pressure BP) measured as millimeters of mercury (mmHg).
|
Baseline to Week 2 Follow-up
|
Change From Baseline in Vital Signs: Supine Heart Rate
Time Frame: Baseline to Week 2 Follow-up
|
Supine heart rate measured as beats per minute (bpm).
|
Baseline to Week 2 Follow-up
|
Change From Baseline in Vital Signs: Weight
Time Frame: Baseline to Week 2 Follow-up
|
Weight measured as kilograms (kg).
|
Baseline to Week 2 Follow-up
|
Change From Baseline in Vital Signs: Temperature
Time Frame: Baseline to Week 2 Follow-up
|
Temperature measured as degrees of Celsius (C).
|
Baseline to Week 2 Follow-up
|
Change From Baseline in Vital Signs: Respiration Rate
Time Frame: Baseline to Week 2 Follow-up
|
Respiration rate measured as respirations per minute (resp/min).
|
Baseline to Week 2 Follow-up
|
Change From Baseline in Chemistry Laboratory Test Data (Measured as mg/dL)
Time Frame: Baseline to Week 2 Follow-up
|
Chemistry laboratory test data measured as milligrams per deciliter (mg/dL).
|
Baseline to Week 2 Follow-up
|
Change From Baseline in Chemistry Laboratory Test Data (Measured as IU/L)
Time Frame: Baseline to Week 2 Follow-up
|
Chemistry laboratory test data measured as international units per (IU/L).
|
Baseline to Week 2 Follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (Actual)
October 1, 2009
Study Completion (Actual)
October 1, 2009
Study Registration Dates
First Submitted
October 19, 2007
First Submitted That Met QC Criteria
October 19, 2007
First Posted (Estimate)
October 23, 2007
Study Record Updates
Last Update Posted (Estimate)
January 17, 2011
Last Update Submitted That Met QC Criteria
December 15, 2010
Last Verified
December 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Systemic Inflammatory Response Syndrome
- Inflammation
- Bacterial Infections and Mycoses
- Sepsis
- Mycoses
- Invasive Fungal Infections
- Fungemia
- Candidiasis
- Candidemia
- Candidiasis, Invasive
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Antifungal Agents
- Steroid Synthesis Inhibitors
- 14-alpha Demethylase Inhibitors
- Anidulafungin
- Voriconazole
Other Study ID Numbers
- A8851015
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Candidemia
-
Taipei Medical University WanFang HospitalCompletedNon-albicans CandidemiaTaiwan
-
Taipei Medical University WanFang HospitalUnknownCandidemia Prognostic Factor and Mycobiological Analysis.Taiwan
-
Fujian Shengdi Pharmaceutical Co., Ltd.Not yet recruitingPatients With Candidemia and/or Invasive Candidiasis
-
Centre Hospitalier Universitaire DijonUnknown
-
Karolinska University HospitalCompletedThe Value of Procalcitonin in Patients With Suspected CandidemiaSweden
-
Radboud University Medical CenterHorizon 2020 - European CommissionRecruitingCandidemiaNetherlands, United States, Switzerland, Germany, Romania, Greece
-
AM-PharmaWithdrawn
-
Assistance Publique - Hôpitaux de ParisUnknownInfection, FungalFrance
-
Universidade Federal do Rio de JaneiroCompleted
Clinical Trials on Anidulafungin
-
Radboud University Medical CenterCompletedLeukemia | Leukemia, Myeloid, Acute | Myelodysplastic SyndromeNetherlands
-
National Cancer Institute (NCI)CompletedUnspecified Childhood Solid Tumor, Protocol Specific | Neutropenia | InfectionUnited States
-
PfizerCompletedCandidiasisUnited Kingdom
-
Daren K. HeylandPfizer; Queen's University; The Physicians' Services Incorporated FoundationTerminatedVentilator Associated Pneumonia | Respiratory Tract InfectionCanada
-
Radboud University Medical CenterCompletedObesity MorbidNetherlands
-
PfizerTerminatedCandidiasis | Fungemia | NeutropeniaPoland, Russian Federation, France, Bosnia and Herzegovina, Italy, Slovakia
-
PfizerVicuron PharmaceuticalsCompleted
-
PfizerVicuron PharmaceuticalsCompleted
-
PfizerVicuron PharmaceuticalsCompleted
-
PfizerVicuron PharmaceuticalsCompletedNeutropeniaUnited States