Micafungin Versus AmBisome in Invasive Candidiasis and Candidemia - Full Text View

Sponsor:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00106288

Purpose

The purpose of this study is to determine the efficacy and safety of micafungin (FK463) versus liposomal amphotericin B (AmBisome) in treating neutropenic and non-neutropenic patients with confirmed invasive candidiasis or candidemia. Enrollment will include adult and pediatric patients.

Condition	Intervention	Phase
Candidiasis	Drug: Micafungin Drug: Liposomal Amphotericin B	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Double Blind, Comparative, Randomized Study to Evaluate the Efficacy and Safety of Micafungin (FK463) Versus Liposomal Amphotericin B (AmBisome) in the Treatment of Invasive Candidiasis and Candidemia

Resource links provided by NLM:

MedlinePlus related topics: Yeast Infections

Drug Information available for: FK 463 Micafungin Amphotericin B

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Investigator's assessment of overall treatment success. Success is defined as clinical (complete or partial) and mycological (eradication or presumed eradication) response at the End of Therapy. [ Time Frame: 6 and 12 weeks post treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical response (complete, partial, stabilization, progression) during the treatment period and the post-treatment period [ Time Frame: During the 2 to 8 week treatment period and the 12 week post treatment followup period ] [ Designated as safety issue: No ]
Mycological response (eradication, presumed eradication, persistence) during the treatment period and the post-treatment period [ Time Frame: During the 2 to 8 week treatment period and the 12 week post treatment followup period ] [ Designated as safety issue: No ]
Overall incidence of emergent and recurrent fungal infections at the End of Study [ Time Frame: End of the 12 week post treatment followup peroid ] [ Designated as safety issue: No ]
Independent Efficacy Review Committee's assessment of overall treatment success [ Time Frame: Prior to database lock ] [ Designated as safety issue: No ]
Peak change of estimated glomerular filtration rate during the treatment period compared to Baseline [ Time Frame: During the 2 to 8 week treatment period ] [ Designated as safety issue: No ]
Incidence of acute infusion related reactions as pre-defined [ Time Frame: During the 2 to 8 week treatment period ] [ Designated as safety issue: No ]
Patient survival at the End of Therapy and at the End of Study [ Time Frame: End of the 2 to 8 week treatment period and end of the 12 week post treatment followup period ] [ Designated as safety issue: No ]
Overall incidence of Adverse Events (AE) [ Time Frame: Throughout study and post treatment followup period ] [ Designated as safety issue: No ]

Enrollment:	637
Study Start Date:	January 2003
Study Completion Date:	December 2005
Primary Completion Date:	December 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Micafungin IV
2: Active Comparator	Drug: Liposomal Amphotericin B IV

Detailed Description:

A phase III, multicenter, double-blind, comparative, parallel, randomized study. Enrollment will include adult and pediatric patients. The adult population is sized to test for non-inferiority. For the pediatric population, descriptive analyses are planned.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients either non-neutropenic with absolute neutrophil counts >= 500 cells/mm3 or neutropenic with absolute neutrophil counts < 500 cells/mm3 must have:

Candidemia or invasive candidiasis,
Confirmation and typical clinical signs and symptoms by fungal culture and/or histology,
Positive culture obtained no more than four days prior to the first dose of study medication.

Exclusion Criteria:

Patient is pregnant or nursing
Patients with evidence of liver disease as defined by: a) SGOT/AST or SGPT/ALT > 10 times the upper limit of normal (ULN); or b) Total bilirubin > 5 times ULN.
Patients whose sole diagnosis is oropharyngeal and/or esophageal candidiasis and/or with positive cultures of urine specimens, sputum specimens, bronchoalveolar-lavage specimens or samples from indwelling drains.
Patients who have received prophylactic/empiric therapy with azoles or conventional amphotericin B for more than three days within one week prior to enrollment. Neutropenic patients, however, may have received prophylactic azoles without time restrictions.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00106288

Show 37 Study Locations

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Chair:

Use Central Contact

Astellas Pharma Europe B.V.

More Information

Additional Information:

Link to results on ClinicalStudyResults.org This link exits the ClinicalTrials.gov site

No publications provided by Astellas Pharma Inc

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Dupont BF, Lortholary O, Ostrosky-Zeichner L, Stucker F, Yeldandi V. Treatment of candidemia and invasive candidiasis in the intensive care unit: post hoc analysis of a randomized, controlled trial comparing micafungin and liposomal amphotericin B. Crit Care. 2009;13(5):R159. Epub 2009 Oct 5.

Queiroz-Telles F, Berezin E, Leverger G, Freire A, van der Vyver A, Chotpitayasunondh T, Konja J, Diekmann-Berndt H, Koblinger S, Groll AH, Arrieta A; Micafungin Invasive Candidiasis Study Group. Micafungin versus liposomal amphotericin B for pediatric patients with invasive candidiasis: substudy of a randomized double-blind trial. Pediatr Infect Dis J. 2008 Sep;27(9):820-6.

Kuse ER, Chetchotisakd P, da Cunha CA, Ruhnke M, Barrios C, Raghunadharao D, Sekhon JS, Freire A, Ramasubramanian V, Demeyer I, Nucci M, Leelarasamee A, Jacobs F, Decruyenaere J, Pittet D, Ullmann AJ, Ostrosky-Zeichner L, Lortholary O, Koblinger S, Diekmann-Berndt H, Cornely OA; Micafungin Invasive Candidiasis Working Group. Micafungin versus liposomal amphotericin B for candidaemia and invasive candidosis: a phase III randomised double-blind trial. Lancet. 2007 May 5;369(9572):1519-27.

Responsible Party:	Astellas Pharma Europe BV ( Disclosure Office Europe )
Study ID Numbers:	FG-463-21-08
Study First Received:	March 22, 2005
Last Updated:	December 9, 2008
ClinicalTrials.gov Identifier:	NCT00106288 History of Changes
Health Authority:	United States: Food and Drug Administration; Australia: Department of Health and Ageing Therapeutic Goods Administration; Thailand: Ministry of Public Health; South Africa: Medicines Control Council; Brazil: National Committee of Ethics in Research; Brazil: National Health Surveillance Agency; Canada: Health Canada; Germany: Federal Institute for Drugs and Medical Devices; Bulgaria: Bulgarian Drug Agency; Switzerland: Swissmedic; Ireland: Irish Medicines Board; Belgium: Ministry of Social Affairs, Public Health and the Environment; France: Afssaps - French Health Products Safety Agency; Spain: Spanish Agency of Medicines; Portugal: National Pharmacy and Medicines Institute; Italy: The Italian Medicines Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Poland: Ministry of Health; Czech Republic: State Institute for Drug Control; Hungary: National Institute of Pharmacy; Slovenia: Ministry of Health; Croatia: Ministry of Health and Social Care; Serbia and Montenegro: Agency for Drugs and Medicinal Devices; Austria: Federal Ministry for Health and Women

Keywords provided by Astellas Pharma Inc:

Candidaemia
Micafungin

Additional relevant MeSH terms:

Abelcet
Amphotericin B
Anti-Infective Agents
Antiprotozoal Agents
Candidiasis
Liposomal amphotericin B
Pharmacologic Actions
Micafungin

Anti-Bacterial Agents
Mycoses
Antiparasitic Agents
Therapeutic Uses
Antifungal Agents
Antibiotics, Antifungal
Amebicides

ClinicalTrials.gov processed this record on February 08, 2010