EFFICACY AND SAFETY OF ERAXIS?/ECALTA (ANIDULAFUNGIN) COMPARED TO CANCIDAS (CASPOFUNGIN) IN NEUTROPENIC PATIENTS WITH INVASIVE CANDIDA INFECTION - ND

• Register: EUCTR
• Last refreshed on: 12 June 2012
• Main ID: EUCTR2008-005277-35-IT
• Date of registration: 17/03/2009
• Prospective Registration: No
• Primary sponsor: PFIZER
• Public title: EFFICACY AND SAFETY OF ERAXIS?/ECALTA (ANIDULAFUNGIN) COMPARED TO CANCIDAS (CASPOFUNGIN) IN NEUTROPENIC PATIENTS WITH INVASIVE CANDIDA INFECTION - ND
• Scientific title: EFFICACY AND SAFETY OF ERAXIS?/ECALTA (ANIDULAFUNGIN) COMPARED TO CANCIDAS (CASPOFUNGIN) IN NEUTROPENIC PATIENTS WITH INVASIVE CANDIDA INFECTION - ND
• Date of first enrolment: 18/12/2008
• Target sample size: 70
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-005277-35
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Bulgaria, France, Ireland, Italy, Netherlands

Key inclusion & exclusion criteria

Inclusion criteria:
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study: 1. Absolute neutrophil count less than or equal to 500 cells/&#956;L. A total WBC count less than or equal to 500 cells/&#956;L meets this criteria (no differential is required); 2. Diagnosis of Candida infection, defined as follows: growth of Candida sp. from a culture specimen obtained from a normally sterile site, the sample having been taken within 96 hours before study entry or at Screening; The diagnosis will be based on at least one of the following: A. Candidemia: At least one blood culture positive for Candida sp. B. Other forms of invasive candidiasis: Positive culture for Candida sp. from a specimen from a normally sterile site with or without a positive blood culture; Positive culture for Candida sp. from a drain placed for <24 hours in a normally sterile site; or Any positive blood culture for Candida sp. plus ophthalmic findings consistent with Candida endophthalmitis. C. At least one of the following: Fever, defined as an oral or tympanic temperature &#8805;38.0C (100.4F); Hypothermia, defined as a temperature less than 36.0C (96.8F); Systolic blood pressure less than 100 mmHg, or a decrease in systolic blood pressure of at least 30 mmHg from baseline; Signs and/or symptoms of Candida infection; Radiologic findings consistent with Candida infection
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Subjects presenting with any of the following will not be included in the study: 1. Females who are pregnant, lactating (breast feeding) or planning a pregnancy during the course of the study, or who are of childbearing potential and not using an acceptable method of birth control (ie, surgically sterile, intrauterine device, oral contraceptive plus barrier contraceptive, hormone delivery system plus barrier contraceptive or condom in combination with contraceptive cream, jelly or foam). Subjects are to continue contraceptive methods during the study and for at least 30 days after receiving their last treatment; 2. Received prior antifungal treatment with either study drug (anidulafungin or caspofungin) within 30 days prior to enrollment in this study. 3. Ongoing antifungal therapy initiated more than 48 hours prior to enrollment. IMPORTANT NOTE: Prior azole prophylaxis is allowed. 4. Requiring continued treatment with another systemic antifungal agent. IMPORTANT NOTE: Use of oral non-absorbable azoles (eg, clotrimazole troches) is permitted. 5. Known to be intolerant to fructose or sucrose. 6. Child-Pugh score > 9 or with any of the following abnormal laboratory values: a. Bilirubin >5 times the upper limit of normal; b. AST or ALT >10 times the upper limit of normal. 7. Poor venous access that would preclude intravenous drug delivery or multiple blood draws. 8. Known hypersensitivity to echinocandin therapy or to any of the excipients used in the formulation of the study drugs. 9. Participated in a study of an investigational drug or device (without any FDA and EMEA approved indications) within 4 weeks of study entry. The investigational use prior to study start and expected to remain on the same stable regimen for the duration of this study; 10. Life expectancy <72 hours. 11. Suspected Candida osteomyelitis, endocarditis, meningitis or any other infections of the central nervous system. 12. Having a prosthetic device and/or intravenous catheter (including a central venous catheter or an implantable port) at a suspected site of infection, unless the device is removed at study entry or soon after randomization. [Hemodialysis shunts (AV fistulae) may remain in situ)]. 13. Having a prosthetic heart valve or vascular graft suspected to be the site of the Candida infection and positive blood cultures. 14. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Invasive candida infections
MedDRA version: 9.1 Level: LLT Classification code 10064954 Term: Invasive candidiasis

Intervention(s)

Trade Name: Ecalta
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Anidulafungin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Powder for solution for injection
Route of administration of the placebo: Intravenous use

Trade Name: CANCIDAS*EV FL 50MG 10ML
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Caspofungin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Powder for infusion*
Route of administration of the placebo: Intravenous use

Trade Name: CANCIDAS*EV FL 70MG 10ML
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Caspofungin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 70-
Pharmaceutical form of the placebo: Powder for infusion*
Route of administration of the placebo: Intravenous use

Trade Name: VFEND*28CPR RIV 50MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Voriconazole
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Trade Name: VFEND*OS FL 45G 40MG/ML
Pharmaceutical Form: Oral suspension
INN or Proposed INN: Voriconazole
Concentration unit: mg/l milligram(s)/litre
Concentration type: equal
Concentration number: 40-

Trade Name: VFEND*28CPR RIV 200MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Voriconazole
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-

Trade Name: DIFLUCAN*7CPS 50MG
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Fluconazole
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Trade Name: DIFLUCAN*10CPS 100MG
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Fluconazole
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Trade Name: DIFLUCAN*7CPS 200MG
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Fluco

Primary Outcome(s)

Main Objective: To assess the efficacy of anidulafungin and caspofungin with respect to the overall global response (clinical and microbiological success) at the EOIVT in neutropenic subjects with a confirmed diagnosis of invasive infection due to Candida sp.

Primary end point(s): The primary efficacy endpoint is the global response at EOIVT in the MITT evaluable population. Global response is based on the following definitions: Success: clinical AND microbiological success; Failure: clinical OR microbiological failure. Clinical and microbiological assessments will be conducted by the Investigator as described in Section 7: Assessments.

Secondary Objective: To evaluate the safety profile of anidulafungin and of caspofungin in this population; To evaluate the clinical and microbiological efficacy of anidulafungin and of caspofungin at various time points.

Secondary ID(s)

A8851021

2008-005277-35-NL