Isavuconazole in the Treatment of Aspergillosis and Rare Fungi - Full Text View

Purpose

The purpose of this study is to investigate the safety and efficacy of isavuconazole in the treatment of invasive fungal infections that are caused by aspergillus and rare fungi.

Condition	Intervention	Phase
Aspergillosis Invasive Fungal Infections	Drug: isavuconazole	Phase III

MedlinePlus related topics:

Fungal Infections Molds

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	Open Label Study of Isavuconazole in the Treatment of Patients With Aspergillosis and Renal Impairment or of Patients With Invasive Fungal Disease Caused by Rare Moulds, Yeasts or Dimorphic Fungi

Further study details as provided by Basilea Pharmaceutica:

Primary Outcome Measures:

Overall outcome of treatment (clinical, mycological and radiological response) [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical response by sub-group [ Designated as safety issue: No ]
Mycological response by pathogen group [ Designated as safety issue: No ]
Survival status by subgroup [ Designated as safety issue: No ]
Overall incidence of adverse events, clinically significant laboratory changes, physical examination, vital signs, ECG, concomitant medication [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	April 2008

Intervention Details:

Administration of 200mg isavuconazole tree times a day iv or oral (in the vein or as a capsule for 2 days, followed by daily administration of 200mg isavuconazole iv or oral

Detailed Description:

Acute invasive fungal infections caused by aspergillus, rare moulds, yeasts or dimorphic fungi are life threatening diseases. Early treatment with highly effective anti-fungals reduces mortality. Isavuconazole is not approved for the treatment of fungal infections. This study investigates the safety and efficacy of isavuconazole in patients with aspergillosis and renal impairment, and in patients suffering from invasive infections from rare fungi.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

patients with proven/probable invasive fungal disease caused by aspergillus fumigatus and who have also renal impairment
patients with proven/probable invasive fungal disease caused by rare moulds, yeasts and dimorphic fungi

Exclusion Criteria:

a known condition of the patient that may jeopardize adherence to the protocol requirements

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00634049

Contacts


Contact: Markus Heep, MD	+41 616061 ext 316	markus.heep@basilea.com

Locations


Australia
		Recruiting
	Woolloongabba, Australia
		Recruiting
	South Brisbane, Australia

Belgium
		Not yet recruiting
	Brussels, Belgium
		Not yet recruiting
	Leuven, Belgium
		Not yet recruiting
	Gent, Belgium
		Not yet recruiting
	Brugge, Belgium
		Not yet recruiting
	Aalst, Belgium

Germany
	49-01		Not yet recruiting
	Berlin, Germany
		Not yet recruiting
	Lübeck, Germany
	49-04		Not yet recruiting
	Berlin, Germany
		Not yet recruiting
	Würzburg, Germany
		Not yet recruiting
	Köln, Germany
		Not yet recruiting
	Leipzig, Germany

Hungary
		Recruiting
	Gyor, Hungary

India
		Not yet recruiting
	Mangalore, India
		Not yet recruiting
	Noida, India
		Not yet recruiting
	Hyderabad, India, 500082
		Not yet recruiting
	Mumbai, India
		Not yet recruiting
	Kolkata, India
		Not yet recruiting
	Hyderabad, India, 500033

Israel
		Not yet recruiting
	Jerusalem, Israel
		Not yet recruiting
	Afula, Israel
		Recruiting
	Haifa, Israel
		Recruiting
	Ramat-Gan, Israel
		Not yet recruiting
	Tel Aviv, Israel
		Recruiting
	Petah Tikva, Israel

Malaysia
		Recruiting
	Ampang, Malaysia

Sponsors and Collaborators

Basilea Pharmaceutica

More Information

Responsible Party:	Basilea Pharmaceutica ( Basilea Pharmaceutica )
Study ID Numbers:	WSA-CS-003
First Received:	March 5, 2008
Last Updated:	July 9, 2008
ClinicalTrials.gov Identifier:	NCT00634049
Health Authority:	United States: Food and Drug Administration

Keywords provided by Basilea Pharmaceutica:

Aspergillosis in patients with renal disease

invasive fungal infections caused by rare molds, rare yeasts

or by dimorphic fungi

Study placed in the following topic categories:

Mycoses

Aspergillosis

Kidney Diseases

Additional relevant MeSH terms:

Infection

ClinicalTrials.gov processed this record on September 23, 2008

Sponsored by:	Basilea Pharmaceutica
Information provided by:	Basilea Pharmaceutica
ClinicalTrials.gov Identifier:	NCT00634049