Isavuconazole in the Treatment of Candidemia and Other Invasive Candida Infections - Full Text View

Sponsored by:	Basilea Pharmaceutica
Information provided by:	Basilea Pharmaceutica
ClinicalTrials.gov Identifier:	NCT00413218

Purpose

The purpose of the study is to compare the safety and efficacy of Isavuconazole versus caspofungin followed by voriconazole in the treatment of candidemia and other invasive Candida infections.

Condition	Intervention	Phase
Mycoses Candidiasis	Drug: Isavuconazole Drug: Caspofungin followed by Voriconazole	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Phase III, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of Isavuconazole Versus Caspofungin Followed by Voriconazole in the Treatment of Candidemia and Other Invasive Candida Infections

Resource links provided by NLM:

MedlinePlus related topics: Fungal Infections Yeast Infections

Drug Information available for: Voriconazole Caspofungin Caspofungin Acetate

U.S. FDA Resources

Further study details as provided by Basilea Pharmaceutica:

Primary Outcome Measures:

Overall response: Resolution of signs and symptoms of infection plus mycological (presumed) eradication

Secondary Outcome Measures:

Mycological response
Time to first confirmed negative culture
All-cause mortality

Estimated Enrollment:	526
Study Start Date:	December 2006

Arms	Assigned Interventions
1: Experimental Isavuconazole	Drug: Isavuconazole Drug treatment
2: Active Comparator Caspofungin followed by Voriconazole	Drug: Caspofungin followed by Voriconazole Drug treatment

Detailed Description:

Candida infections, representing approximately 80% of all major systemic fungal infections, are the fourth most common cause of nosocomial bloodstream infections, with a mortality rate of 40%. Isavuconazole is not yet approved for the treatment of fungal infections. This study investigates the efficacy and safety of intravenous and oral Isavuconazole. Patients are randomized to Isavuconazole and the reference regimen. Patients with a positive blood- or deep tissue culture of candida fungi can be included.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with systemic candida infection
Positive blood or deep tissue culture.

Exclusion Criteria:

Patients with a sole diagnosis of mucocutaneous candidiasis, i.e. oropharyngeal, esophageal or genital candidiasis; or candidal lower urinary tract infection or Candida isolated solely from respiratory tract specimens.
Patients with candidemia who failed a previous antifungal therapy for the same infection.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00413218

Contacts

Contact: Markus Heep, MD

41-616-061 ext 316

markus.heep@basilea.com

Show 150 Study Locations

Sponsors and Collaborators

Basilea Pharmaceutica

Investigators

Study Director:

Markus Heep, MD

Basilea Pharmaceutica

More Information

No publications provided

Responsible Party:	Basilea Pharmaceutica ( Markus Heep, MD )
Study ID Numbers:	WSA-CS-008
Study First Received:	December 18, 2006
Last Updated:	July 10, 2008
ClinicalTrials.gov Identifier:	NCT00413218 History of Changes
Health Authority:	United States: Food and Drug Administration; European Union: European Medicines Agency; Australia: National Health and Medical Research Council

Keywords provided by Basilea Pharmaceutica:

Phase III study
Isavuconazole
Candidemia
Invasive Candida infections
Candidemia and other invasive candida infections

Study placed in the following topic categories:

Anti-Infective Agents
Mycoses
Candidiasis
Antifungal Agents

Caspofungin
Voriconazole
Torulopsis

Additional relevant MeSH terms:

Anti-Infective Agents
Mycoses
Candidiasis
Therapeutic Uses
Antifungal Agents

Caspofungin
Voriconazole
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2009