Single Patient Treatment of Posaconazole in Invasive Fungal Infections (Study P05113)(COMPLETED)
This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
First received: May 27, 2008
Last updated: October 4, 2013
Last verified: October 2013
The purpose of this study is to provide posaconazole compassionate treatment to patients with invasive fungal infections: 1) which are resistant to standard antifungal therapies; 2) for which there are no effective therapies; 3) with a prior history of serious, severe, or life-threatening toxicities while receiving standard antifungal therapies, or 4) with pre-existing organ dysfunction which precludes the use of standard antifungal therapies.
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Single Patient Emergency Treatment Use of Posaconazole in Invasive Fungal Infections
Primary Outcome Measures:
- Clinical efficacy and safety of use [ Time Frame: Clinical outcome and adverse events measured every 3 months until the drug is marketed in the country. ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||January 2010 (Final data collection date for primary outcome measure)
Experimental: Single arm
Posaconazole oral suspension 400 mg twice daily with meal or nutritional supplement. Alternatively, if meal or nutritional supplement is not tolerated, posaconazole should be administered at a dose of 200 mg four times a day.
Other Name: SCH 056592
NCT00686621 was voluntarily registered even though it is a single patient use study, also known as compassionate exemption study; therefore results will not be disclosed for this study.
|Ages Eligible for Study:
||2 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
General Inclusion Criteria:
- Adults (age >=18 years) of either gender and of any race.
- Children (age >= 2 to 17 years) of either gender and of any race, who are not eligible for enrollment under any current clinical trial. Compassionate use will be permitted only under the direct supervision of qualified experts in pediatric infectious diseases with the written approval of the Schering Plough medical director (local country operations or headquarters project director).
- Subject or his/her legally authorized representative has given signed, written informed consent,
- Ability to take study medication orally by swallowing or via an enteral feeding tube.
- Subject is not considered eligible for any other clinical research program with posaconazole.
Safety Related Inclusion Criteria
Invasive Fungal Infection Inclusion Criteria
Each patient must have:
- A documented invasive fungal infection who have failed a reasonable trial of other licensed antifungal agents, either due to progression or lack of improvement of the infection, or
- Serious, severe or life-threatening toxicities related to current or prior antifungal therapy, or
- An invasive fungal infection for which there are currently no effective therapies.
- Patients with debilitating but not immediately life threatening fungal diseases, where significant morbidity may result in disability and where prior antifungal therapy has been unsuccessful (eg, chronic mucocutaneous candidiasis, recurrent oropharyngeal or esophageal candidiasis with dehydration and malnutrition, or cutaneous phaeohyphomycosis and mycetoma).
- Women who are pregnant or who will continue to breast-feed infants.
- History of serious or severe hypersensitivity or idiosyncratic reactions to azole antifungals.
- Patients who require ongoing treatment with any prohibited medication (see Core Clinical Data Sheet and list of Prohibited Medications) and for whom an appropriate washout period has not elapsed.
- Patients who are in a situation or have any condition requiring the use of prohibited drugs or unstable medical conditions where the risk of therapy would exceed any potential benefit i.e., hematological disorder such as unstable cardiac disorder (including acute myocardial infarction or unstable myocardial ischemia/angina within 30 days, ventricular arrhythmia within 30 days, uncontrolled atrial fibrillation, or atrial fibrillation/flutter with symptomatic bradycardia [sick sinus syndrome], or unstable congestive heart failure) or impairment expected to be unstable or progressive during the course of this study (e.g., recurrent or uncontrolled seizure disorders, demyelinating syndromes, or progressive peripheral neuropathy).
- Patients receiving vinca alkaloids or anthracyclines within 24 hours of study enrollment or requiring therapy with vinca alkaloids or anthracyclines within the next 30 days for treatment of uncontrolled (pre-existing) malignancy or requiring ongoing therapy with vinca alkaloids or anthracyclines, where the risk of toxicity from these medicinal products is considered to be significant.
- Any condition requiring the use of prohibited drugs (please consult current product labeling).
- Hepatic function tests: alanine amino transferase (ALT) or aspartate aminotransferase (AST) >10 times upper limit of normal, or evidence of severe hepatic dysfunction based on other clinical assessment.
No Contacts or Locations Provided
No publications provided
||Merck Sharp & Dohme Corp.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 27, 2008
||October 4, 2013
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 16, 2014