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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 March 14, 2019

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.
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- 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.
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- 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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