Micafungin Versus AmBisome in Invasive Candidiasis and Candidemia

Candidiasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00106288
• Other study ID #: FG-463-21-08
• Status: Completed
• Phase: Phase 3
• First received: March 22, 2005
• Last updated: September 17, 2014
• Start date: January 2003
• Est. completion date: December 2005

Study information

• Verified date: September 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods AdministrationThailand: Ministry of Public HealthSouth Africa: Medicines Control CouncilBrazil: National Committee of Ethics in ResearchBrazil: National Health Surveillance AgencyCanada: Health CanadaGermany: Federal Institute for Drugs and Medical DevicesBulgaria: Bulgarian Drug AgencySwitzerland: SwissmedicIreland: Irish Medicines BoardBelgium: Ministry of Social Affairs, Public Health and the EnvironmentFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Spain: Spanish Agency of MedicinesPortugal: National Pharmacy and Medicines InstituteItaly: The Italian Medicines AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyPoland: Ministry of HealthCzech Republic: State Institute for Drug ControlHungary: National Institute of PharmacySlovenia: Ministry of HealthCroatia: Ministry of Health and Social CareSerbia and Montenegro: Agency for Drugs and Medicinal DevicesAustria: Federal Ministry for Health and Women
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 637
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Candidemia
• Candidiasis
• Candidiasis, Invasive

Intervention

Drug:
• Micafungin
IV
• Liposomal Amphotericin B
IV

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (3)

Horn DL, Ostrosky-Zeichner L, Morris MI, Ullmann AJ, Wu C, Buell DN, Kovanda LL, Cornely OA. Factors related to survival and treatment success in invasive candidiasis or candidemia: a pooled analysis of two large, prospective, micafungin trials. Eur J Clin Microbiol Infect Dis. 2010 Feb;29(2):223-9. doi: 10.1007/s10096-009-0843-0. Epub 2009 Dec 15. — View Citation

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. — View Citation

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. doi: 10.1097/INF.0b013e31817275e6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		6 and 12 weeks post treatment	No
Secondary	Clinical response (complete, partial, stabilization, progression) during the treatment period and the post-treatment period		During the 2 to 8 week treatment period and the 12 week post treatment followup period	No
Secondary	Mycological response (eradication, presumed eradication, persistence) during the treatment period and the post-treatment period		During the 2 to 8 week treatment period and the 12 week post treatment followup period	No
Secondary	Overall incidence of emergent and recurrent fungal infections at the End of Study		End of the 12 week post treatment followup peroid	No
Secondary	Independent Efficacy Review Committee's assessment of overall treatment success		Prior to database lock	No
Secondary	Peak change of estimated glomerular filtration rate during the treatment period compared to Baseline		During the 2 to 8 week treatment period	No
Secondary	Incidence of acute infusion related reactions as pre-defined		During the 2 to 8 week treatment period	No
Secondary	Patient survival at the End of Therapy and at the End of Study		End of the 2 to 8 week treatment period and end of the 12 week post treatment followup period	No
Secondary	Overall incidence of Adverse Events (AE)		Throughout study and post treatment followup period	No

External Links

•   Link to Results on JAPIC - enter 140598 in the JapicCTI-RNo. field