OPEN-LABEL, NON-COMPARATIVE, STUDY OF INTRAVENOUSANIDULAFUNGIN, FOLLOWED OPTIONALLY BY ORAL VORICONAZOLE ORFLUCONAZOLE THERAPY, FOR TREATMENT OF DOCUMENTEDCANDIDEMIA/INVASIVE CANDIDIASIS IN INTENSIVE CARE UNIT PATIENTPOPULATIONS

• Conditions: CANDIDAEMIA/INVASIVE CANDIDIASIS; MedDRA version: 9.1Level: LLTClassification code 10064954Term: Invasive candidiasis

• Registration Number: EUCTR2007-004854-97-GB
• Lead Sponsor: Pfizer Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 186

Inclusion Criteria

Subjects who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures.
• Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
1. Male or female patient =18 years of age.
2. No contraindications to anidulafungin administration.
3. Patients with documented Candidemia (at least one blood culture positive for yeast) documented within 96 hours prior to initiation of study treatment.
or
Documented invasive candidiasis (histopathologic, microbiologic or cytopathologic examination of a needle aspiration, fluid sample or biopsy specimen from a normally sterile site excluding mucous membranes showing yeast cells) documented within 96 hours prior to initiation of study treatment.
Patients may be enrolled with a presumptive diagnosis of Candidemia, in which case a culture must be obtained at the screening visit and following completion of written informed consent, as well as daily thereafter in accordance with the protocol. Positive yeast cultures from urine in the absence of clinical symptoms of pyelonephritis; or a positive yeast culture from sputum, obtained by bronchoalveolar lavage or endotracheal aspirate, do not qualify as a positive culture. Candidemia patients who are later found to have no positive bloods culture from any of the three samples taken at screening or within 48 hours after commencing treatment will be considered to not meet entry criteria and will be withdrawn. This will then be considered as an early withdrawal and not as a treatment failure.
4. ICU patients with a diagnosis of documented candidemia or invasive candidiasis and belonging to one or more of the following specific populations:
• Post-abdominal surgery.
• Elderly > 65 years old.
• Renal insufficiency / failure / hemodialysis.
• Solid tumor.
• Solid-organ (liver, kidney, lung, heart) transplant recipients.
• Hepatic insufficiency.
• Neutropenic including hematology oncology patients.
5. Presence of one or more of the following signs and symptoms of acute fungal
infection within 48 hours prior to initiation of study treatment:
• Temperature =38,5°C or a hypothermia, defined as a core temperature <35.0°C.
• Heart rate >90/minute.
• Respiratory frequency>20/minute or PaCO2<32 mm Hg or mechanical
ventilation.
• White cell >12000/mm3 or <4000/mm3 or immature forms >10%.
• Localized signs and symptoms of inflammation (swelling, heat, erythema or purulence at a site infected with Candida spp.).
6. Patients having received another anti fungal treatment may be enrolled if in the opinion of the investigator the patient will benefit from the inclusion in the study and:
• The patient has received a systemic antifungal treatment other than an echinocandin, for no more than 48 hours prior to study entry and is showing no sign of improvement.
or
• The patient has received no more than 1 dose of an echinochandin
7. APACHE II score <25 at study entry or within the 48 hours prior to study entry.
8. Patients willing and able to give informed consent, or have a legally authorized
representative willing to give informed consent on their behalf. The person considered as the legally authorized representative must be in accordance with local law and Ethics Committee policices, including but not limited to a family member.
9. Expected survival (in the opinion of the investigator) greater than 4 days.
Are the trial subjects under 18? no
Number of subjects for this age range:

Exclusion Criteria

Subjects presenting with any of the following will not be included in the study:
1. Patients with poor venous access that would preclude IV drug delivery or multiple blood draws.
2. Patients with a known hypersensitivity or contraindications the use of anidulafungin, voriconazole or fluconazole or to any of the excipients.
3. Patient who have participated in a study of an investigational drug or device within four weeks of study entry.
4. Patient with suspected Candida osteomyelitis, endocarditis, meningitis, endopthalmitis.
5. Patient with a prosthetic device at a suspected site of infection unless the device was removed at study entry and prior to study drug initiation (hemodialysis shunts [AV fistulae] could remain in situ).
6. Female patients who are pregnant, lactating, or planning a pregnancy during the course of the study, or who are of child bearing potential and not using an acceptable method of birth control. Female patients should continue contraceptive methods during the study and for at least 28 days after receiving their last treatment.
7. Other severe or acute 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 & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified