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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Posaconazole | Experimental | Posaconazole 400 mg twice a day (BID) oral suspension for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Posaconazole | Drug | 400mg BID oral suspension for 12 weeks |
|
| 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 |
| 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. |
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Inclusion Criteria:
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
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.
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22324990 | Result | Huang X, Wang F, Chen Y, Liu T, Wang J, Hu J, Jie J, Chen F, Wang S, Shen Z, Yu L, Yu K, Liang Y. A multicenter, open-label study of posaconazole oral suspension in the treatment of invasive fungal infections in patients refractory to or intolerant of first-line therapy. Future Microbiol. 2012 Feb;7(2):201-9. doi: 10.2217/fmb.11.158. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Posaconazole | 400 mg twice a day (BID) oral suspension for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Posaconazole | 400 mg twice a day (BID) oral suspension for 12 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | 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. | Pool of participants were from the FAS: included all randomized participants who received at least one dose of study drug and who had valid data of primary efficacy endpoint for at least one follow-up visit after treatment. Did not include the 3 participants from the SS population (n=62) who withdrew from the study. | Posted | Number | Particpants | Treatment week 4 |
|
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63 participants were screened and enrolled; 62 participants started on study drug and comprised the Safety Set (SS). SS population included randomized subjects who received at least one dose of study drug and valid data of safety endpoints was available for at least one follow-up visit after treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | POSACONAZOLE | 400mg oral suspension BID for 12 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PERICARDIAL EFFUSION | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL DISCOMFORT | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C101425 | posaconazole |
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| 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 |
| Withdrawal by Subject |
|
| Cumulative use of antifungal agent |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Posaconazole |
400 mg twice a day (BID) oral suspension for 12 weeks |
|
|
| Secondary | 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. | Pool of participants were from the FAS: included all randomized participants who received at least one dose of study drug and who had valid data of primary efficacy endpoint for at least one follow-up visit after treatment. Did not include the 3 participants from the SS population (n=62) who withdrew from the study. | Posted | Number | Participants | Treatment week 8 |
|
|
|
| Secondary | 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. | Only FAS participants with positive fungal culture (of suspected site or blood) were evaluated. Last Observation Carried Forward (LOCF) was used for missing data. | Posted | Number | Participants | Treatment week 4 |
|
|
|
| Secondary | 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. | Only FAS participants with positive fungal culture (of suspected site or blood) were evaluated. LOCF was used for missing data. | Posted | Number | Participants | Treatment week 8 |
|
|
|
| Secondary | 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. | Only FAS participants with positive fungal culture (of suspected site or blood) were evaluated. LOCF was used for missing data. | Posted | Number | Participants | Treatment week 12 |
|
|
|
| Secondary | 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. | Pool of participants were from the FAS: included all randomized participants who received at least one dose of study drug and who had valid data of primary efficacy endpoint for at least one follow-up visit after treatment. Did not include the 3 participants from the SS population (n=62) who withdrew from the study. | Posted | Number | Participants | Follow-up week 14 |
|
|
|
| Primary | 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. | Pool of participants were from the Full Analysis Set (FAS): included all randomized participants who received at least one dose of study drug and who had valid data of primary efficacy endpoint for at least one follow-up visit after treatment. Did not include the 3 participants from the SS population (n=62) who withdrew from the study. | Posted | Number | Participants | Treatment week 12 |
|
|
|
| 5 |
| 62 |
| 40 |
| 62 |
| HAEMATEMESIS | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| ANAL ABSCESS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| LUNG INFECTION | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| ACUTE LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
|
| CEREBRAL HAEMORRHAGE | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA 13.1 | Systematic Assessment |
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| OEDEMA PERIPHERAL | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| HEPATIC FUNCTION ABNORMAL | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
|
| LUNG INFECTION | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| RASH | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
Principal Investigator (PI) agrees not to publish or publicly present any interim results of the Protocol study without the prior written consent of the Sponsor. PI further agrees to provide to the Sponsor thirty (30) days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the Protocol study. The sponsor shall have editorial rights with respect to publications, abstracts, slides, and manuscripts.
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