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:
Merck
Collaborator:
JSS Medical Research Inc.
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00550732
First received: October 29, 2007
Last updated: December 11, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Mycoses |
Drug: posaconazole |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study on Treatment of Refractory Fungal Infections With Posaconazole. The "TIP" Study. |
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- Proportion of participants with complete response (CR) or partial response (PR) [ Time Frame: At least 12 weeks or until end of treatment (up to 6 months) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number of participants with ≥50% decrease in lesion size or number [ Time Frame: At least 12 weeks or until end of treatment (up to 6 months) ] [ Designated as safety issue: No ]
- Time to response of target lesion [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
- Duration of clinical response in participants with CR or PR [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
- Number of participants with infection-free survival after the last dose of study drug [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: At 3 months and up to 6 months ] [ Designated as safety issue: No ]
- Number of participants with response to posaconazole in combination therapy [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
- Number of participants experiencing adverse events (AEs) [ Time Frame: Baseline to study completion or participant discontinuation ] [ Designated as safety issue: Yes ]
| Enrollment: | 40 |
| Study Start Date: | December 2007 |
| Study Completion Date: | November 2012 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Posaconazole |
Drug: posaconazole
posaconazole oral suspension, 400 mg twice daily, or 200 mg 4 times daily for participants intolerant of food or nutritional supplements
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT00550732 History of Changes |
| Other Study ID Numbers: | P05090 |
| Study First Received: | October 29, 2007 |
| Last Updated: | December 11, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Merck:
|
Triazoles |
Additional relevant MeSH terms:
|
Mycoses Posaconazole Antifungal Agents Anti-Infective Agents Therapeutic Uses |
Pharmacologic Actions Trypanocidal Agents Antiprotozoal Agents Antiparasitic Agents |
ClinicalTrials.gov processed this record on June 17, 2013