Postmarketing Surveillance Study on the Labeled Use of Oral Posaconazole 40 mg/mL Suspension (Study P04641)(COMPLETED) - Full Text View

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00726609

Purpose

The purpose of this postmarketing surveillance study is to collect an extensive body of data in a large patient population in every day life to investigate the efficacy and safety of NOXAFIL® (posaconazole) in the treatment of invasive fungal disease.

Condition	Intervention
Mycoses	Drug: Posaconazole

MedlinePlus related topics: Fungal Infections

Drug Information available for: Posaconazole

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Postmarketing Surveillance Study on the Labeled Use of NOXAFIL® 40 mg/mL Suspension for Oral Use

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Safety: Adverse Reactions occurring during therapy. [ Time Frame: Before starting treatment with posaconazole and during treatment until the end of treatment. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Efficacy: therapy outcome Usage of posaconazole in clinical practice. [ Time Frame: Before starting treatment with posaconazole and during treatment until the end of treatment. ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	130
Study Start Date:	January 2006
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Patients Adult subjects with invasive aspergillosis, fusariosis, chromoblastomycosis, mycetoma or coccidiomycosis resistant to, or intolerant of, treatment with amphotericin B, itraconazole or fluconazole.	Drug: Posaconazole The usual dose of NOXAFIL® is 400 mg twice daily (10 mL) at meals or with 240 mL of a food supplement. For patients unable to take meals or food supplements, NOXAFIL® is administered at a dose of 200 mg (5 mL) four times daily.

Detailed Description:

Data regarding demographics, underlying disease, prior fungal infection, prior antifungal medication, IFI signs & symptoms, concomitant medication, posaconazole use, tolerability, safety and therapy outcome is collected on abstracted eCRFs. This surveillance is limited to patients receiving posaconazole as salvage antifungal therapy as indicated.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

IFI patients refractory to first-line treatment or unable to tolerate it will be selected at hospitals in Germany.

Criteria

Inclusion Criteria:

Adult subjects with invasive aspergillosis, fusariosis, chromoblastomycosis, mycetoma or coccidiomycosis resistant to, or intolerant of, treatment with amphotericin B, itraconazole or fluconazole.

Resistance to treatment is defined as progression of infection or no response after at least 7 days of an effective antifungal treatment administered at therapeutic doses.

Exclusion Criteria:

N/A. The treating physician decides upon the use of posaconazole according to label.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00726609

Locations

Germany
Coordinating Location
Munich, Germany

Sponsors and Collaborators

Schering-Plough

More Information

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P04641
Study First Received:	July 30, 2008
Last Updated:	October 29, 2008
ClinicalTrials.gov Identifier:	NCT00726609
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Mycoses
Clotrimazole
Miconazole
Tioconazole
Posaconazole

Additional relevant MeSH terms:

Trypanocidal Agents
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents

Therapeutic Uses
Antifungal Agents
Antibiotics, Antifungal
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009