A Study to Examine the Efficacy and Safety of Posaconazole When Introduced Early in the Treatment of Refractory Fungal Infections (P05090 AM2) (TIP)

This study has been completed.
Sponsor:
Collaborator:
JSS Medical Research Inc.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00550732
First received: October 29, 2007
Last updated: June 2, 2014
Last verified: June 2014

October 29, 2007
June 2, 2014
December 2007
November 2012   (final data collection date for primary outcome measure)
Percentage of Participants With Complete Response (CR) or Partial Response (PR) by 12 Weeks or End of Treatment [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
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.
Complete (resolution of clinical, radiologic and mycologic abnormalities, if present at baseline) or partial (meaningful improvement in clinical, radiologic and mycologic abnormalities, if present at baseline) response to posaconazole treatment. [ Time Frame: The proportion of subjects who respond to treatment will be reported at the end of treatment or at 12 weeks, whichever comes first. ]
Complete list of historical versions of study NCT00550732 on ClinicalTrials.gov Archive Site
  • Number of Participants With ≥50% Decrease in Lesion Size or Number [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 12 Weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 26 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Total number of participant survivors was assessed at 3 months.
  • Number of Participants With Response to Posaconazole in Combination Therapy [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
    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.
a) Response to treatment. b) Decrease in target lesion size. c) Time to response. d) Duration of clinical response. e) Infection-free survival at 6 months after the last study dose. f) Safety of posaconazole therapy. g) Survival at 3 months. [ Time Frame: 3 months to 6 months ]
Not Provided
Not Provided
 
A Study to Examine the Efficacy and Safety of Posaconazole When Introduced Early in the Treatment of Refractory Fungal Infections (P05090 AM2)
A Phase II Study on Treatment of Refractory Fungal Infections With Posaconazole. The "TIP" Study.

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Mycoses
Drug: Posaconazole
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.
Other Names:
  • SCH056592
  • Noxafil®
Experimental: Posaconazole
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: Drug: Posaconazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
November 2012
November 2012   (final data collection date for primary outcome measure)

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.
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00550732
P05090
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
JSS Medical Research Inc.
Not Provided
Merck Sharp & Dohme Corp.
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP