Expired Study
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Birmingham, Alabama 35294


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.


Study summary:

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.


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.


Study is Available At:


Original ID:

FG-463-21-08


NCT ID:

NCT00106288


Secondary ID:


Study Acronym:


Brief Title:

Micafungin Versus AmBisome in Invasive Candidiasis and Candidemia


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


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Astellas Pharma Inc


Oversight 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


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

637


Enrollment Type:

Actual


Overall Contact Information

Official Name:Use Central Contact
Study Chair
Astellas Pharma Europe B.V.

Study Dates

Start Date:January 2003
Completion Date:December 2005
Completion Type:Actual
Primary Completion Date:December 2005
Primary Completion Type:Actual
Verification Date:September 2014
Last Changed Date:September 17, 2014
First Received Date:March 22, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Overall incidence of Adverse Events (AE)
Time Frame:Throughout study and post treatment followup period
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Incidence of acute infusion related reactions as pre-defined
Time Frame:During the 2 to 8 week treatment period
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Peak change of estimated glomerular filtration rate during the treatment period compared to Baseline
Time Frame:During the 2 to 8 week treatment period
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Independent Efficacy Review Committee's assessment of overall treatment success
Time Frame:Prior to database lock
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Overall incidence of emergent and recurrent fungal infections at the End of Study
Time Frame:End of the 12 week post treatment followup peroid
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Micafungin
Description:IV
Arm Name:1
Other Name:Mycamine
Intervention Type:Drug
Name:Liposomal Amphotericin B
Description:IV
Arm Name:2
Other Name:AmBisome

Study Arms

Study Arm Type:Experimental
Arm Name:1
Study Arm Type:Active Comparator
Arm Name:2

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Astellas Pharma Inc

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation: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.
PMID:20013016
Reference Type:Reference
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.
PMID:18679151
Reference Type:Reference
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.
PMID:17482982

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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