Posaconazole Treatment of Invasive Fungal Infection (IFI) (P05551) (COMPLETED)

This study has been completed.

Sponsor:

Information provided by:

Schering-Plough

ClinicalTrials.gov Identifier:

NCT00811642

First received: December 18, 2008

Last updated: March 31, 2011

Last verified: March 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	December 18, 2008
Last Updated Date	March 31, 2011
Start Date ^ICMJE	November 2008
Primary Completion Date	March 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 31, 2011)	Number of Participants Who Had Clinical Response at 12 Weeks With Posaconazole Treatment [ Time Frame: Treatment week 12 ] [ Designated as safety issue: No ] EVALUATION OF PARTICIPANTS' CLINICAL RESPONSE BASED ON CRITERIA: Complete Response: resolution of Invasive Fungal Infection (IFI) attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment. Partial Response: clinically significant improvement in IFI attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment, of which, one still had not achieved complete recession. Stable disease: no progress in IFI attributable symptoms, if present at enrollment. Failure: deterioration in IFI attributable clinical symptoms.
Original Primary Outcome Measures ^ICMJE (submitted: December 18, 2008)	Cumulative clinical effective rate at the end of POS treatment [ Time Frame: The maximum duration <=12 weeks since randomization ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00811642 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 31, 2011)	Number of Participants Who Had Clinical Response at 4 Weeks With Posaconazole Treatment [ Time Frame: Treatment week 4 ] [ Designated as safety issue: No ] EVALUATION OF PARTICIPANTS' CLINICAL RESPONSE BASED ON CRITERIA: Complete Response: resolution of IFI attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment. Partial Response: clinically significant improvement in IFI attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment, of which, one still had not achieved complete recession. Stable disease: no progress in IFI attributable symptoms, if present at enrollment. Failure: deterioration in IFI attributable clinical symptoms. Number of Participants Who Had Clinical Response at 8 Weeks With Posaconazole Treatment [ Time Frame: Treatment week 8 ] [ Designated as safety issue: No ] EVALUATION OF PARTICIPANTS' CLINICAL RESPONSE BASED ON CRITERIA: Complete Response: resolution of IFI attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment. Partial Response: clinically significant improvement in IFI attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment, of which, one still had not achieved complete recession. Stable disease: no progress in IFI attributable symptoms, if present at enrollment. Failure: deterioration in IFI attributable clinical symptoms. Number of Participants With Pathogenic Fungal Eradication at 4 Weeks With Posaconazole Treatment [ Time Frame: Treatment week 4 ] [ Designated as safety issue: No ] EVALUATION OF FUNGAL ERADICATION: Participants' mycological response to therapy was assessed by the following: Eradication: Negative culture or histologically documented absence of infecting fungal pathogen from a primary site previously positive. Presumed Eradication: Resolution of all IFI attributable symptoms, signs and laboratory or radiological abnormalities in which a repeat culture/biopsy was contraindicated. Persistence: Continued isolation of fungal pathogen from a primary site previously positive or cytological documentation of presence of fungal pathogen. Number of Participants With Pathogenic Fungal Eradication at 8 Weeks With Posaconazole Treatment [ Time Frame: Treatment week 8 ] [ Designated as safety issue: No ] EVALUATION OF FUNGAL ERADICATION: Participants' mycological response to therapy was assessed by the following: Eradication: Negative culture or histologically documented absence of infecting fungal pathogen from a primary site previously positive. Presumed Eradication: Resolution of all IFI attributable symptoms, signs and laboratory or radiological abnormalities in which a repeat culture/biopsy was contraindicated. Persistence: Continued isolation of fungal pathogen from a primary site previously positive or cytological documentation of presence of fungal pathogen. Number of Participants With Pathogenic Fungal Eradication at 12 Weeks With Posaconazole Treatment [ Time Frame: Treatment week 12 ] [ Designated as safety issue: No ] EVALUATION OF FUNGAL ERADICATION: Participants' mycological response to therapy was assessed by the following: Eradication: Negative culture or histologically documented absence of infecting fungal pathogen from a primary site previously positive. Presumed Eradication: Resolution of all IFI attributable symptoms, signs and laboratory or radiological abnormalities in which a repeat culture/biopsy was contraindicated. Persistence: Continued isolation of fungal pathogen from a primary site previously positive or cytological documentation of presence of fungal pathogen. Number of Participant Survivors at Week 14 of Post-Posaconazole Treatment Follow-up [ Time Frame: Follow-up week 14 ] [ Designated as safety issue: No ] Total number of participant deaths was assessed at the end of 2 week post-treatment follow-up (14 weeks). The total number of deaths was compared to the number of survivors at baseline.
Original Secondary Outcome Measures ^ICMJE (submitted: December 18, 2008)	Cumulative clinical effective rate at 4W, 8W of POS treatment [ Time Frame: The maximum duration <=12 weeks since randomization ] [ Designated as safety issue: No ] Cumulative pathogenic fungal eradication rate at 4W, 8W and the end of POS treatment [ Time Frame: The maximum duration <=12 weeks since randomization ] [ Designated as safety issue: No ] Cumulative survival rate at the end of POS treatment [ Time Frame: The maximum duration <=12 weeks since randomization ] [ Designated as safety issue: Yes ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Posaconazole Treatment of Invasive Fungal Infection (IFI) (P05551) (COMPLETED)
Official Title ^ICMJE	A Multicenter, Open Label Study to Evaluate Safety and Efficacy of Posaconazole Oral Suspension in Treatment of Invasive Fungal Infection
Brief Summary	The purpose of this multicenter, open label study, is to evaluate the safety and efficacy of a 12-week treatment with Posaconazole Oral Suspension in participants with IFI
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Mycoses
Intervention ^ICMJE	Drug: Posaconazole 400mg BID oral suspension for 12 weeks Other Name: Noxafil
Study Arm (s)	Experimental: Posaconazole Posaconazole 400 mg twice a day (BID) oral suspension for 12 weeks Intervention: Drug: Posaconazole
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	63
Completion Date	March 2010
Primary Completion Date	March 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Participants must be 18-70 years male or female Identified or clinically diagnosed IFI participants or high risk population who are resistant to, or recurrent from, or intolerable to, or may suffer toxic reaction from standard antifungal treatment. Sign informed consent form Exclusion Criteria: Female participants who are pregnant or are nursing. Participants with known or suspected hypersensitivity or idiosyncratic reaction to azole agents or amphotericin B Participants with progressive nervous system diseases( excluding those IFI caused) Participants who take the following drugs known with interference with azole antifungal preparations terfenadine, cisapride, and ebastine within 24 hours before entry astemizole at entry or within 10 days before entry cimetidine, rifampin, carbamazepine, phenytoin, rifabutin, barbiturates, isoniazid atharanthine and anthracyclines within 24 hours before entry The drugs listed above are prohibited during the investigation Serious organ diseases except hematological disorder such as cardiac or neurologic disorders or impairment expected to be unstable or progressive during the course of this study (eg, seizures or demyelinating syndromes, acute myocardial infarction within 3 months of study entry, myocardial ischemia, congestive heart failure, atrial fibrillation with ventricular rate <60/min, or history of torsades de pointes, symptomatic ventricular or sustained arrhythmias), unstable electrolyte abnormalities. Participants having an ECG with a prolonged QTc interval: QTc greater than 450 msec for men and greater than 470 msec for women. Expected to take during investigation or is taking systemic antifungal treatment Participants with severe renal insufficiency (estimated creatinine clearance less than 50 mL/minute or likely to require dialysis during the study), ALT,AST AKP or total bilirubin are >2×ULN. Participants expected to survive no more than 72hrs Participants receiving artificial aeration and will not withdraw within 24hrs Participants who have used any investigational drugs or biologic agents or anticipated other clinical trials within 30 days of study entry. Prior enrollment in this study. History of alcohol and/or drug abuse. Participants cannot be compliant in investigator's opinion.
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00811642
Other Study ID Numbers ^ICMJE	P05551
Has Data Monitoring Committee	No
Responsible Party	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Schering-Plough
Verification Date	March 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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