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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00106288
Other study ID # FG-463-21-08
Secondary ID
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


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
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