Infection, Invasive FungalNCT00230243
Historical Control Study of Refractory IFI or Patients Intolerant to Standard Antifungal Therapy in Patients With Invasive Fungal Infections (Study P02387)
An observational study of Infection, Invasive Fungal, run by Merck Sharp & Dohme LLC.
Trial summary
This retrospective study is designed to provide a consistent method of screening and collecting data on patients who will serve as controls for a comparison of the efficacy of the available antifungal therapies used as salvage treatments for patients with refractory IFI or for patients with refractory IFI or for… Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Infection, Invasive Fungal
- How many people
- 330 participants
- Where
- No sites listed yet
- Study dates
- Mar 1997to Sep 2002
- Phase
- Observational
- Are there results?
- None posted in the registry
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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Males and females of any race greater than or equal to 13 years of age
- Treatment for an IFI between April 30, 1996 and April 30, 2001 at one of the centers participating in P00041 or at other non-P00041 centers
- A diagnosis of proven or probable IFI based on MSG/EORTC criteria
- Refractory IFI or intolerence to standard therapy
- The date of diagnosis of an IFI will be the earliest date on which one or more of the following diagnostic procedures used to establish the diagnosis was performed:
- Fungal culture, histopathology, bronchoscopy, and autopsy report
- X-Rays, CT scan, MRI, ultrasound, and bone scan
- Serology
Who cannot join
- Female subject who was pregnant or nursing at the time IFI was diagnosed
- Hepatic function tests: ALT or AST greater than 10 times the upper limit of normal at the time IFI was diagnosed
- Enrollment in P00041 for treatment of the IFI
- Patient with sarcoidosis, aspergilloma, or allergic bronchopulmonary aspergillosis
- Patients with chronic invasive aspergillosis (chronic necrotizing pulmonary aspergillosis)
- Patients with diagnosis of CMV pneumonia
Show all 9Show fewer
- Patients with a diagnosis of pulmonary tuberculosis
- Death within 72 hours of the start of antifungal therapy
- Patients on artificial ventilation, who were not extubated within 24 hours of commencing standard antifungal therapy
About this study
Official title: A Retrospective Study to Establish an Historical Database on the Efficacy of Standard Antifungal Therapy in Patients With Invasive Fungal Infections
This retrospective study is designed to provide a consistent method of screening and collecting data on patients who will serve as controls for a comparison of the efficacy of the available antifungal therapies used as salvage treatments for patients with refractory IFI or for patients with refractory IFI or for patients with IFI who are intolerant to standard antifungal therapies.
Read the detailed description
The current clinical trial is designed to provide historicals controls comparable to the P00041 study population, that is, a) patients with invasive fungal infections which are refractory or resistant to standard antifungal therapies or b) patients who have developed intolerance to standard antifungal therapy. This clinical trial also serves to allow collection of historical data regarding the efficacy of available antifungal therapies against a variety of invasive fungal infections which although serious and life-threatening are sufficiently rare so that they cannot be studied in a controlled, randomized clinical trial.
This trial will be conducted primarily at the investigative sites that enrolled subjects into P00041 and/or investigators who are members of the Mycosis Study Group.
- Conditions
- Infection, Invasive Fungal
- Keywords
- Aspergillosis, CandidiasisMucormycosis, FusariosisCryptococcosis, Endemic Fungal infections, Phaeohyphomycosis
- Medical subject headings
- Invasive Fungal Infections, Aspergillosis, Phaeohyphomycosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2005 (estimated)
- Study startMar 1997
- Primary completionSep 2002
- Study completionSep 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, Invasive FungalStudies 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
- Time perspective
- Retrospective
- Enrolment
- 330 participants
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
- NCT00230243
- Sponsor's protocol ID
- P02387
- Status last verified
- Mar 2017
- First submitted
- 28 Sep 2005
- Last updated
- 10 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study to Establish an Historical Database on the Efficacy of Standard Antifungal Therapy in Patients With Invasive Fungal Infections
- ClinicalTrials.gov ID
- NCT00230243
- Acronym / sponsor ID
- P02387
- Conditions
- Infection, Invasive Fungal
- Keywords
- Aspergillosis, CandidiasisMucormycosis, FusariosisCryptococcosis, Endemic Fungal infections, Phaeohyphomycosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 1997
- Primary completion
- Sep 2002 (actual)
- Study completion
- Sep 2002 (actual)
- First posted
- 30 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This retrospective study is designed to provide a consistent method of screening and collecting data on patients who will serve as controls for a comparison of the efficacy of the available antifungal therapies used as salvage treatments for patients with refractory IFI or for patients with refractory IFI or for patients with IFI who are intolerant to standard antifungal therapies.
Detailed description
The current clinical trial is designed to provide historicals controls comparable to the P00041 study population, that is, a) patients with invasive fungal infections which are refractory or resistant to standard antifungal therapies or b) patients who have developed intolerance to standard antifungal therapy. This clinical trial also serves to allow collection of historical data regarding the efficacy of available antifungal therapies against a variety of invasive fungal infections which although serious and life-threatening are sufficiently rare so that they cannot be studied in a controlled, randomized clinical trial.
This trial will be conducted primarily at the investigative sites that enrolled subjects into P00041 and/or investigators who are members of the Mycosis Study Group.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Males and females of any race greater than or equal to 13 years of age
- Treatment for an IFI between April 30, 1996 and April 30, 2001 at one of the centers participating in P00041 or at other non-P00041 centers
- A diagnosis of proven or probable IFI based on MSG/EORTC criteria
- Refractory IFI or intolerence to standard therapy
- The date of diagnosis of an IFI will be the earliest date on which one or more of the following diagnostic procedures used to establish the diagnosis was performed:
Key exclusion criteria (9 listed)
- Female subject who was pregnant or nursing at the time IFI was diagnosed
- Hepatic function tests: ALT or AST greater than 10 times the upper limit of normal at the time IFI was diagnosed
- Enrollment in P00041 for treatment of the IFI
- Patient with sarcoidosis, aspergilloma, or allergic bronchopulmonary aspergillosis
- Patients with chronic invasive aspergillosis (chronic necrotizing pulmonary aspergillosis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2017.
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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 Infection, Invasive Fungal, 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 8 inclusion and 9 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 10 Mar 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 10 Mar 2017.