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Post-marketing Surveillance Study of Invasive Mycosis With Posaconazole (Study P04641)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00726609
Recruitment Status : Completed
First Posted : August 1, 2008
Results First Posted : September 22, 2009
Last Update Posted : March 5, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Brief Summary:
The purpose of this postmarketing surveillance study is to collect an extensive body of data in a large patient population in every day life to investigate the safety and efficacy of NOXAFIL® (posaconazole) in the treatment of invasive fungal disease.

Condition or disease Intervention/treatment
Mycoses Drug: Posaconazole

Detailed Description:

Data regarding demographics, underlying disease, prior fungal infection, prior antifungal medication, invasive fungal infection signs & symptoms, concomitant medication, posaconazole use, tolerability, safety and therapy outcome will be collected on abstracted electronic Case Report Forms.

This surveillance study was originally limited to subjects receiving posaconazole as salvage antifungal therapy as indicated. A subgroup of subjects at risk for invasive fungal infection was included for prophylactic treatment following the enlargement of the marketing authorization for NOXAFIL® (posaconazole) during the course of the study. These participants only contributed data for the assessment of safety.

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Study Type : Observational
Actual Enrollment : 214 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Post-marketing Surveillance (PMS) Management of Invasive Mycosis With Posaconazole
Study Start Date : January 2006
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Posaconazole (assigned by physician in normal practice)
  • Treatment of invasive fungal infection.
  • Prophylaxis of invasive fungal infection.
Drug: Posaconazole
The usual dose of NOXAFIL® is 400 mg twice daily (10 mL) at meals or with 240 mL of a food supplement. For patients unable to take meals or food supplements, NOXAFIL® is administered at a dose of 200 mg (5 mL) four times daily.
Other Names:
  • SCH 56592

Primary Outcome Measures :
  1. Number of Participants Reporting Adverse Drug Reactions. [ Time Frame: Before starting treatment with posaconazole, during treatment, and until 100 days after treatment. ]

    The severity of an Adverse Drug Reaction is determined on the basis of the following definitions:

    Mild: The abnormality, symptom or event is noticed but well tolerated.

    Moderate: Symptoms impair normal activities and may require intervention.

    Severe: Clinical status is significantly impaired, normal activity is no longer possible, intervention is required.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Subjects with invasive fungal infection refractory to first-line treatment or unable to tolerate it were selected at hospitals in Germany.

Following the enlargement of the marketing authorization for posaconazole, subjects at risk for invasive fungal infection were also enrolled.


Inclusion Criteria:

Adult subjects with:

  • Invasive aspergillosis refractory to, or intolerant of, amphotericin B or itraconazole,
  • Fusariosis refractory to, or intolerant of, amphotericin B,
  • Chromoblastomycosis and mycetoma refractory to, or intolerant of, itraconazole,
  • Coccidiomycosis refractory to, or intolerant of, amphotericin B, itraconazole or fluconazole.
  • Subjects receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk for developing invasive fungal infections.
  • Hematopoietic stem-cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for Graft-versus-host disease and who are at high risk for developing invasive fungal infections.

Exclusion Criteria:

  • Comedication of the participant with ergotamine, dihydroergotamine, terfenadine, astemizole, cisapride, pimozide, halofantrine, or chinidine.
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Responsible Party: Merck Sharp & Dohme LLC Identifier: NCT00726609    
Other Study ID Numbers: P04641
First Posted: August 1, 2008    Key Record Dates
Results First Posted: September 22, 2009
Last Update Posted: March 5, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Invasive Fungal Infections
Bacterial Infections and Mycoses
Antifungal Agents
Anti-Infective Agents
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs