NCT00036179

Brief Summary

The purpose of the study is to evaluate the safety and efficacy of FK463 in the treatment of patients with confirmed candidemia or invasive candidiasis.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 1999

Typical duration for phase_2

Geographic Reach
8 countries

23 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 27, 1999

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2002

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 9, 2002

Completed
Last Updated

January 10, 2018

Status Verified

June 1, 2015

Enrollment Period

2.9 years

First QC Date

May 8, 2002

Last Update Submit

January 8, 2018

Conditions

Candidiasis

Keywords

CandidemiaAnti-Fungal

Interventions

FK463DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Has Candidemia or invasive candidiasis documented by typical clinical signs and symptoms and confirmed by fungal culture or histologic confirmation

You may not qualify if:

  • Has abnormal liver test parameters, e.g., AST or ALT \> 10 times upper limit of normal
  • Has life expectancy judged to be less than 5 days
  • De novo patients who have received a systemic antifungal agent for the treatment of this episode of candidemia or invasive candidiasis for more than 48 hours prior to the first dose of FK463; or efficacy failure patients who have received =\< 5 days of prior systemic antifungal therapy for the treatment of this episode of candidemia or invasive candidiasis
  • Require treatment with topical or systemic antifungal agents for conditions other than candidemia or invasive candidiasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Medizinische Univ.-Klinik

Graz, A 8036, Austria

Location

Krankenhaus Elisabethinen Linz

Linz, A-4010, Austria

Location

Hopital Henri Mondor, Dervice d'Hematologie Clinique

Créteil, 94010, France

Location

Hotel Dieu, Service d"Hematologie

Nantes, 44093, France

Location

Hopital Saint Louis, Service D'Hematologie/Greffe de Moelle

Paris, 10, France

Location

Hopital Necker Enfants Malades, Service d"Hematologie

Paris, 75015, France

Location

Johann Wolfgang Goethe Universitat, Medizinische Klinik III

Frankfurt, D-60590, Germany

Location

Westpfalz Krankenhaus

Kaiserslautern, D-67655, Germany

Location

Medizinische Klinik und Poliklinik II, Abt. Hamatologie und Onkologie

Leipzig, D-04103, Germany

Location

Klinikum der Stadt, Medizinische Klinik A

Ludwigshafen, D-67063, Germany

Location

Uniklinik Mainz, III. Medizinische Klinik

Mainz, 55101, Germany

Location

LMU Munchen, Hamatopoetische Zell - Transplantation

München, D-81366, Germany

Location

Universitat Wurzburg, Institut fur Molekulare und Infectionsbiologie

Würzburg, D-97070, Germany

Location

Nationale Institute for Cancer Research

Genova, I 16132, Italy

Location

Ospedale Niguarda-Ca Granda, Dept. of Internal Medicine Padiglione Brera

Milan, 20162, Italy

Location

Institute of Haematology and Blood Transfusion

Warsaw, 00-957, Poland

Location

Hospital Clinic I Provencial, Servicio Enfermadades Infecciosas

Barcelona, 28041, Spain

Location

Hospital Gregorio Maranon, Servicio de Enfermadades Infecciosas

Madrid, ES 28007, Spain

Location

Hospital Doce de Octubre, Servicio de Microbiologia Y Enfermadades Infecciosas

Madrid, ES 28041, Spain

Location

Huddinge University Hospital, Dept. of Transplantation Surgery/Immunology

Huddinge, SE141 86, Sweden

Location

Royal Free Hospital, Dept. of Haematological Oncology

London, NW3 2QG, United Kingdom

Location

Christie Hospital NHS Trust

Manchester, M20 4BX, United Kingdom

Location

Royal Marsden Hospital

Sutton Surrey, SM2 5PT, United Kingdom

Location

Related Links

MeSH Terms

Conditions

CandidiasisCandidemia

Interventions

Micafungin

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfectionsCandidiasis, InvasiveInvasive Fungal InfectionsFungemiaSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LipopeptidesLipidsPeptidesAmino Acids, Peptides, and ProteinsEchinocandinsPeptides, Cyclic

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2002

First Posted

May 9, 2002

Study Start

February 27, 1999

Primary Completion

January 27, 2002

Study Completion

January 27, 2002

Last Updated

January 10, 2018

Record last verified: 2015-06

Locations

AU(2)DE(7)SE(1)FR(4)PL(1)GB(3)IT(2)ES(3)