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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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Brasilia, DF, 70710-905 Brazil
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Candidemia, Invasive Candidiasis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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 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.

NCT00548262
Pfizer
Completed
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

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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
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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Candidemia
  • Invasive Candidiasis
  • Drug: Anidulafungin
    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 Name: Eraxis
  • Drug: Voriconazole
    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 Name: Vfend
Experimental: 1
Interventions:
  • Drug: Anidulafungin
  • Drug: Voriconazole
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
October 2009
October 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Brazil,   Chile,   Colombia,   Mexico,   Panama
Venezuela
 
NCT00548262
A8851015
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

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1-800-718-1021

BY EMAIL

Contact

[email protected]



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