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

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 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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: Amphotericin B Micafungin sodium Micafungin Liposomal 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
Experimental: 1	Drug: Micafungin IV Other Names: Mycamine FK463
Active Comparator: 2	Drug: Liposomal Amphotericin B IV Other Name: AmBisome

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

No publications provided by Astellas Pharma Inc

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Shorr AF, Wu C, Kothari S. Outcomes with micafungin in patients with candidaemia or invasive candidiasis due to Candida glabrata and Candida krusei. J Antimicrob Chemother. 2011 Feb;66(2):375-80. Epub 2010 Dec 8.

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:	Disclosure Office Europe, Astellas Pharma Europe BV
ClinicalTrials.gov Identifier:	NCT00106288 History of Changes
Other Study ID Numbers:	FG-463-21-08
Study First Received:	March 22, 2005
Last Updated:	December 9, 2008
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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) 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:

Candidiasis
Candidemia
Candidiasis, Invasive
Mycoses
Fungemia
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Amphotericin B

Liposomal amphotericin B
Micafungin
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 16, 2013