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

Study Overview
=================
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

Official Title
-----------------
A Multicenter, Open Label Study to Evaluate Safety and Efficacy of Posaconazole Oral Suspension in Treatment of Invasive Fungal Infection

Conditions
-----------------
Fungal Infection

Intervention / Treatment
-----------------
* Drug: Posaconazole


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Posaconazole<br>Posaconazole 400 mg twice a day (BID) oral suspension for 12 weeks | Drug: Posaconazole<br>* 400mg BID oral suspension for 12 weeks<br>* Other names: Noxafil;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Had Clinical Response at 12 Weeks With Posaconazole Treatment | 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. | Treatment week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Had Clinical Response at 4 Weeks With Posaconazole Treatment | 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. | Treatment week 4 | 
| Number of Participants Who Had Clinical Response at 8 Weeks With Posaconazole Treatment | 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. | Treatment week 8 | 
| Number of Participants With Pathogenic Fungal Eradication at 4 Weeks With Posaconazole Treatment | 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. | Treatment week 4 | 
| Number of Participants With Pathogenic Fungal Eradication at 8 Weeks With Posaconazole Treatment | 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. | Treatment week 8 | 
| Number of Participants With Pathogenic Fungal Eradication at 12 Weeks With Posaconazole Treatment | 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. | Treatment week 12 | 
| Number of Participant Survivors at Week 14 of Post-Posaconazole Treatment Follow-up | 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. | Follow-up week 14 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
refractory or first line medication intolerable invasive fungal infection