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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00726609
First received: July 30, 2008
Last updated: March 22, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention
Mycoses
 Drug: Posaconazole

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Post-marketing Surveillance (PMS) Management of Invasive Mycosis With Posaconazole

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

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

    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.



Enrollment: 214
Study Start Date: January 2006
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
  • NOXAFIL®

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00726609

Locations
Germany
Coordinating Location
Munich, Germany
Sponsors and Collaborators
Merck
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT00726609     History of Changes
Other Study ID Numbers: P04641
Study First Received: July 30, 2008
Results First Received: August 13, 2009
Last Updated: March 22, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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 May 16, 2013