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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00726609
First received: July 30, 2008
Last updated: March 17, 2014
Last verified: March 2014

July 30, 2008
March 17, 2014
January 2006
July 2008   (final data collection date for primary outcome measure)
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.

Safety: Adverse Reactions occurring during therapy. [ Time Frame: Before starting treatment with posaconazole and during treatment until the end of treatment. ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00726609 on ClinicalTrials.gov Archive Site
Not Provided
Efficacy: Therapy Outcome Usage of Posaconazole in Clinical Practice. [ Time Frame: Before starting treatment with posaconazole and during treatment until the end of treatment. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Post-marketing Surveillance Study of Invasive Mycosis With Posaconazole (Study P04641)
Post-marketing Surveillance (PMS) Management of Invasive Mycosis With Posaconazole

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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.

Mycoses
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®
Posaconazole (assigned by physician in normal practice)
  • Treatment of invasive fungal infection.
  • Prophylaxis of invasive fungal infection.
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
214
July 2008
July 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00726609
P04641
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
March 2014

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