MycosesNCT00726609
Post-marketing Surveillance Study of Invasive Mycosis With Posaconazole (Study P04641)
An observational study of Mycoses, run by Merck Sharp & Dohme LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mycoses
- What is being tested?
- Posaconazole
- How many people
- 214 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Jul 2008
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Comedication of the participant with ergotamine, dihydroergotamine, terfenadine, astemizole, cisapride, pimozide, halofantrine, or chinidine.
About this study
Official title: 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.
Read the 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.
- Conditions
- Mycoses
- Being tested
- Posaconazole
- Medical subject headings
- Mycoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PosaconazoleDrug
Also called SCH 56592, NOXAFIL®
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.
| Study group | Role | What they receive |
|---|---|---|
| Posaconazole (assigned by physician in normal practice) | * Treatment of invasive fungal infection.
* Prophylaxis of invasive fungal infection. Receives: Drug: Posaconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting Adverse Drug Reactions.
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.
Measured: Before starting treatment with posaconazole, during treatment, and until 100 days after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2008 (estimated)
- Study startJan 2006
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MycosesStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00726609
- Sponsor's protocol ID
- P04641
- Status last verified
- Feb 2015
- First submitted
- 30 Jul 2008
- Last updated
- 5 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Surveillance (PMS) Management of Invasive Mycosis With Posaconazole
- ClinicalTrials.gov ID
- NCT00726609
- Acronym / sponsor ID
- P04641
- Conditions
- Mycoses
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 1 Aug 2008 (estimated)
- Results
- Posted 22 Sep 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Posaconazole (assigned by physician in normal practice) | – | Drug: Posaconazole* Treatment of invasive fungal infection. * Prophylaxis of invasive fungal infection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (1 listed)
- Comedication of the participant with ergotamine, dihydroergotamine, terfenadine, astemizole, cisapride, pimozide, halofantrine, or chinidine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PosaconazoleAlso: SCH 56592, NOXAFIL®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. | Drug | Posaconazole (assigned by physician in normal practice) |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Mycoses, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Sep 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2015.