Back to resultsA Study to Examine the Efficacy and Safety of Posaconazole When Introduced Early in the Treatment of Refractory Fungal Infections (P05090 AM2) (TIP)
Primary Purpose
Mycoses
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Posaconazole
Sponsored by
About this trial
This is an interventional treatment trial for Mycoses focused on measuring Triazoles
Eligibility Criteria
Inclusion Criteria:
- Proven or probable invasive fungal infection (IFI) including breakthrough infection while on antifungal treatment for at least 7 days.
- Refractory or intolerant to prior antifungal therapy, or medically unable to receive standard antifungal therapy.
- Age ≥13 years old.
- Expected to survive >1 month.
- Negative pregnancy test (serum or urine) at baseline for women of childbearing potential.
Exclusion Criteria:
- Serum bilirubin >10 times upper limit of normal (ULN).
- Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >10 times ULN.
- Documented allergy to azoles.
- Unable to take oral suspension medications or enteral feeding.
- Pregnant or breastfeeding.
- Participants who have received an investigational drug are allowed to be enrolled if the investigational drug was given 30 days prior to study registration, unless approved by the Sponsor.
- Requires surgery.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Posaconazole
Arm Description
Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
Outcomes
Primary Outcome Measures
Percentage of Participants With Complete Response (CR) or Partial Response (PR) by 12 Weeks or End of Treatment
Complete Response was defined as resolution of all attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline. Partial Response was defined as clinically meaningful improvement in attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline.
Secondary Outcome Measures
Number of Participants With ≥50% Decrease in Lesion Size or Number
Reduction in lesion size was analyzed by computed tomography (CT) scan. An imaging response was defined as >=50% reduction in lesion size for pulmonary and cerebral disease or >=50% reduction in the number of lesions for liver disease.
Percentage of Participants With a CR or PR by 12 Weeks
Complete Response was defined as resolution of all attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline. Partial Response was defined as clinically meaningful improvement in attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline.
Percentage of Participants With CR or PR by 4 Weeks and by 26 Weeks
Complete Response was defined as resolution of all attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline. Partial Response was defined as clinically meaningful improvement in attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline.
Percentage of Participants With Infection-free Survival After the Last Dose of Study Drug
Infection-free survival was the proportion of evaluable participants included in the efficacy analysis who are infection-free and alive at 6 months post last dose visit. Infection-free is defined as the resolution of signs and symptoms of infection.
Overall Survival at 3 Months
Total number of participant survivors was assessed at 3 months.
Number of Participants With Response to Posaconazole in Combination Therapy
Complete Response was defined as resolution of all attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline. Partial Response was defined as clinically meaningful improvement in attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline.
Number of Participants Experiencing Adverse Events (AEs)
An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the study drug.
Full Information
NCT ID
NCT00550732
First Posted
October 29, 2007
Last Updated
March 9, 2017
Sponsor
Merck Sharp & Dohme LLC
Collaborators
JSS Medical Research Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00550732
Brief Title
A Study to Examine the Efficacy and Safety of Posaconazole When Introduced Early in the Treatment of Refractory Fungal Infections (P05090 AM2)
Acronym
TIP
Official Title
A Phase II Study on Treatment of Refractory Fungal Infections With Posaconazole. The "TIP" Study.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
Collaborators
JSS Medical Research Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of posaconazole in the early treatment of fungal infections in participants who are refractory to, intolerant to, or medically precluded from first-line monotherapy or first-line combination antifungal therapy.
Detailed Description
In the past two decades, invasive fungal infections (IFI) have become increasingly common among immunocompromised people, including solid-organ or hematopoietic stem-cell transplant recipients, those with HIV infection, those with hematological malignancies, and individuals on immunosuppressive drug regimens. There is a high rate of morbidity and mortality associated with IFI. Over the past decade, there has been an increase in resistance to commonly used antifungal agents and an epidemiological shift to more drug-resistant strains. This has demonstrated the need for the development of a new generation of azoles.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mycoses
Keywords
Triazoles
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Posaconazole
Arm Type
Experimental
Arm Description
Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
Intervention Type
Drug
Intervention Name(s)
Posaconazole
Other Intervention Name(s)
SCH056592, Noxafil®
Intervention Description
Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
Primary Outcome Measure Information:
Title
Percentage of Participants With Complete Response (CR) or Partial Response (PR) by 12 Weeks or End of Treatment
Description
Complete Response was defined as resolution of all attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline. Partial Response was defined as clinically meaningful improvement in attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline.
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
Number of Participants With ≥50% Decrease in Lesion Size or Number
Description
Reduction in lesion size was analyzed by computed tomography (CT) scan. An imaging response was defined as >=50% reduction in lesion size for pulmonary and cerebral disease or >=50% reduction in the number of lesions for liver disease.
Time Frame
Up to 6 months
Title
Percentage of Participants With a CR or PR by 12 Weeks
Description
Complete Response was defined as resolution of all attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline. Partial Response was defined as clinically meaningful improvement in attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline.
Time Frame
Up to 12 Weeks
Title
Percentage of Participants With CR or PR by 4 Weeks and by 26 Weeks
Description
Complete Response was defined as resolution of all attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline. Partial Response was defined as clinically meaningful improvement in attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline.
Time Frame
Up to 26 weeks
Title
Percentage of Participants With Infection-free Survival After the Last Dose of Study Drug
Description
Infection-free survival was the proportion of evaluable participants included in the efficacy analysis who are infection-free and alive at 6 months post last dose visit. Infection-free is defined as the resolution of signs and symptoms of infection.
Time Frame
Up to 6 months
Title
Overall Survival at 3 Months
Description
Total number of participant survivors was assessed at 3 months.
Time Frame
3 months
Title
Number of Participants With Response to Posaconazole in Combination Therapy
Description
Complete Response was defined as resolution of all attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline. Partial Response was defined as clinically meaningful improvement in attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline.
Time Frame
Up to 6 months
Title
Number of Participants Experiencing Adverse Events (AEs)
Description
An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the study drug.
Time Frame
Up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Proven or probable invasive fungal infection (IFI) including breakthrough infection while on antifungal treatment for at least 7 days.
Refractory or intolerant to prior antifungal therapy, or medically unable to receive standard antifungal therapy.
Age ≥13 years old.
Expected to survive >1 month.
Negative pregnancy test (serum or urine) at baseline for women of childbearing potential.
Exclusion Criteria:
Serum bilirubin >10 times upper limit of normal (ULN).
Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >10 times ULN.
Documented allergy to azoles.
Unable to take oral suspension medications or enteral feeding.
Pregnant or breastfeeding.
Participants who have received an investigational drug are allowed to be enrolled if the investigational drug was given 30 days prior to study registration, unless approved by the Sponsor.
Requires surgery.
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
http://engagezone.msd.com/ds_documentation.php
Learn more about this trial
A Study to Examine the Efficacy and Safety of Posaconazole When Introduced Early in the Treatment of Refractory Fungal Infections (P05090 AM2)
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