MycosesNCT00686621
Single Patient Treatment of Posaconazole in Invasive Fungal Infections (Study P05113)
A study testing Posaconazole in people with Mycoses, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to provide posaconazole compassionate treatment to patients with invasive fungal infections: 1) which are resistant to standard antifungal therapies; 2) for which there are no effective therapies; 3) with a prior history of serious, severe, or life-threatening toxicities while receiving… Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Mycoses
- What is being tested?
- Posaconazole
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- General Inclusion Criteria:
- Adults (age >=18 years) of either gender and of any race.
- Children (age >= 2 to 17 years) of either gender and of any race, who are not eligible for enrollment under any current clinical trial. Compassionate use will be permitted only under the direct supervision of qualified experts in pediatric infectious diseases with the written approval of the Schering Plough medical director (local country operations or headquarters project director).
- Subject or his/her legally authorized representative has given signed, written informed consent,
- Ability to take study medication orally by swallowing or via an enteral feeding tube.
- Subject is not considered eligible for any other clinical research program with posaconazole.
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- Safety Related Inclusion Criteria
- Male or a female patient who meets any one of the following criteria:
- postmenopausal, surgically sterilized, or documented to have primary ovarian failure due to prior cytotoxic chemotherapy or radiation therapy; abstinent from sexual intercourse or practicing effective birth control. Effective birth control methods must continue for at least 30 days after discontinuation of treatment with posaconazole.
- Known to be non pregnant by history or (preferably) by negative serum or urine pregnancy test prior to the first dose of posaconazole for all females of childbearing potential.
- Not breast feeding or if lactating, willing to discontinue breast feeding during treatment.
- Invasive Fungal Infection Inclusion Criteria
- Each patient must have:
- A documented invasive fungal infection who have failed a reasonable trial of other licensed antifungal agents, either due to progression or lack of improvement of the infection, or
- Serious, severe or life-threatening toxicities related to current or prior antifungal therapy, or
- An invasive fungal infection for which there are currently no effective therapies.
- Patients with debilitating but not immediately life threatening fungal diseases, where significant morbidity may result in disability and where prior antifungal therapy has been unsuccessful (eg, chronic mucocutaneous candidiasis, recurrent oropharyngeal or esophageal candidiasis with dehydration and malnutrition, or cutaneous phaeohyphomycosis and mycetoma).
Who cannot join
- Women who are pregnant or who will continue to breast-feed infants.
- History of serious or severe hypersensitivity or idiosyncratic reactions to azole antifungals.
- Patients who require ongoing treatment with any prohibited medication (see Core Clinical Data Sheet and list of Prohibited Medications) and for whom an appropriate washout period has not elapsed.
- Patients who are in a situation or have any condition requiring the use of prohibited drugs or unstable medical conditions where the risk of therapy would exceed any potential benefit i.e., hematological disorder such as unstable cardiac disorder (including acute myocardial infarction or unstable myocardial ischemia/angina within 30 days, ventricular arrhythmia within 30 days, uncontrolled atrial fibrillation, or atrial fibrillation/flutter with symptomatic bradycardia [sick sinus syndrome], or unstable congestive heart failure) or impairment expected to be unstable or progressive during the course of this study (e.g., recurrent or uncontrolled seizure disorders, demyelinating syndromes, or progressive peripheral neuropathy).
- Patients receiving vinca alkaloids or anthracyclines within 24 hours of study enrollment or requiring therapy with vinca alkaloids or anthracyclines within the next 30 days for treatment of uncontrolled (pre-existing) malignancy or requiring ongoing therapy with vinca alkaloids or anthracyclines, where the risk of toxicity from these medicinal products is considered to be significant.
- Any condition requiring the use of prohibited drugs (please consult current product labeling).
- Hepatic function tests: alanine amino transferase (ALT) or aspartate aminotransferase (AST) >10 times upper limit of normal, or evidence of severe hepatic dysfunction based on other clinical assessment.
About this study
Official title: Single Patient Emergency Treatment Use of Posaconazole in Invasive Fungal Infections
The purpose of this study is to provide posaconazole compassionate treatment to patients with invasive fungal infections: 1) which are resistant to standard antifungal therapies; 2) for which there are no effective therapies; 3) with a prior history of serious, severe, or life-threatening toxicities while receiving standard antifungal therapies, or 4) with pre-existing organ dysfunction which precludes the use of standard antifungal therapies.
Read the detailed description
NCT00686621 was voluntarily registered even though it is a single patient use study, also known as compassionate exemption study; therefore results will not be disclosed for this study.
- 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 056592
Posaconazole oral suspension 400 mg twice daily with meal or nutritional supplement. Alternatively, if meal or nutritional supplement is not tolerated, posaconazole should be administered at a dose of 200 mg four times a day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Expanded access
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
- NCT00686621
- Sponsor's protocol ID
- P05113
- Status last verified
- Nov 2018
- First submitted
- 27 May 2008
- Last updated
- 3 Dec 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Patient Emergency Treatment Use of Posaconazole in Invasive Fungal Infections
- ClinicalTrials.gov ID
- NCT00686621
- Acronym / sponsor ID
- P05113
- Conditions
- Mycoses
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- First posted
- 30 May 2008 (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.
The purpose of this study is to provide posaconazole compassionate treatment to patients with invasive fungal infections: 1) which are resistant to standard antifungal therapies; 2) for which there are no effective therapies; 3) with a prior history of serious, severe, or life-threatening toxicities while receiving standard antifungal therapies, or 4) with pre-existing organ dysfunction which precludes the use of standard antifungal therapies.
Detailed description
NCT00686621 was voluntarily registered even though it is a single patient use study, also known as compassionate exemption study; therefore results will not be disclosed for this study.
Study design
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (17 listed)
- Adults (age >=18 years) of either gender and of any race.
- Children (age >= 2 to 17 years) of either gender and of any race, who are not eligible for enrollment under any current clinical trial. Compassionate use will be permitted only under the direct supervision of qualified experts in pediatric infectious diseases with the written approval of the Schering Plough medical director (local country operations or headquarters project director).
- Subject or his/her legally authorized representative has given signed, written informed consent,
- Ability to take study medication orally by swallowing or via an enteral feeding tube.
- Subject is not considered eligible for any other clinical research program with posaconazole.
Key exclusion criteria (7 listed)
- Women who are pregnant or who will continue to breast-feed infants.
- History of serious or severe hypersensitivity or idiosyncratic reactions to azole antifungals.
- Patients who require ongoing treatment with any prohibited medication (see Core Clinical Data Sheet and list of Prohibited Medications) and for whom an appropriate washout period has not elapsed.
- Patients who are in a situation or have any condition requiring the use of prohibited drugs or unstable medical conditions where the risk of therapy would exceed any potential benefit i.e., hematological disorder such as unstable cardiac disorder (including acute myocardial infarction or unstable myocardial ischemia/angina within 30 days, ventricular arrhythmia within 30 days, uncontrolled atrial fibrillation, or atrial fibrillation/flutter with symptomatic bradycardia [sick sinus syndrome], or unstable congestive heart failure) or impairment expected to be unstable or progressive during the course of this study (e.g., recurrent or uncontrolled seizure disorders, demyelinating syndromes, or progressive peripheral neuropathy).
- Patients receiving vinca alkaloids or anthracyclines within 24 hours of study enrollment or requiring therapy with vinca alkaloids or anthracyclines within the next 30 days for treatment of uncontrolled (pre-existing) malignancy or requiring ongoing therapy with vinca alkaloids or anthracyclines, where the risk of toxicity from these medicinal products is considered to be significant.
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 056592Posaconazole oral suspension 400 mg twice daily with meal or nutritional supplement. Alternatively, if meal or nutritional supplement is not tolerated, posaconazole should be administered at a dose of 200 mg four times a day. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2018.
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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?
A study testing Posaconazole in people with 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 17 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 3 Dec 2018. 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?
Results are not available in the source record.
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 3 Dec 2018.