CANDIDAEMIA/INVASIVE CANDIDIASIS MedDRA version: 9.1 Level: LLT Classification code 10064954 Term: Invasive candidiasis
Conditions
Interventions
Trade Name: Ecalta®
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: Anidulafungin
CAS Number: 166663-25-8
Concentration unit: mg milligram(s)
Concentration t
Sponsors
Pfizer Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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 blood 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at screening or within 48 hours after commencing treatment will be considered to not meet entry criteria and will be withdrawn.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 90/minute. • Respiratory frequency>20/minute or PaCO212000/mm3 or 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 policies, 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: F.1.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of anidulafungin for the treatment of Documented Candidemia and Invasive Candidiasis in the following adult specific ICU patient populations with one or more of the following covariates: • Post-abdominal surgery. • Elderly > 65 years old. • Renal insufficiency / failure /dialysis. • Solid tumor. • Solid-organ (liver, kidney, lung, heart, pancreas) transplant recipients. • Hepatic insufficiency. • Neutropenic including hematology oncology patients. The primary efficacy endpoint will be the global (clinical and microbiological) response at the End Of all Treatment (EOT). The global response will be assessed by the investigator based on a combination of clinical and microbiological responses.;Secondary Objective: To assess the global treatment response at the End Of IV (EOIV) treatment with anidulafungin. To assess global response at 2 weeks after EOT. To assess global response at 6 weeks after EOT. To assess the safety and tolerability of anidulafungin in these adult specific ICU patient populations. To measure the time to first negative blood/tissue culture. To evaluate the Day 90 survival (Day 1 being defined as the first day of therapy with anidulafungin). To measure the time to ICU discharge. ;Primary end point(s): The primary efficacy endpoint will be the global treatment response at the EOT. The global response will be assessed by the investigator based on a combination of clinical and microbiological outcomes, and will be defined as: • Global success: Clinical success and microbiological success. • Global failure: All other combinations. Clinical success will be recorded when the clinical response is cure or improvement. The clinical response will be assessed by the investigator using the following definitions: • Cure: Resolution of the signs and symptoms of the Candida infection. • Improvement: Significant, but incomplete resolution of the signs and symptoms of the Candida infection. • Failure: No significant improvement | — |
Countries
Austria, Belgium, Czech Republic, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Slovakia, United Kingdom
Outcome results
None listed