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Posaconazole for Fungal Infection
Study Summary
This trial will study how a drug called posaconazole works in young children with a fungal infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have a fungal infection that is not candidiasis, and it responds to POS medication.I have had symptoms of a fungal infection for less than 30 days.I have or might have Gilbert's syndrome.If you are suspected of having a fungal infection, you have certain risk factors that make it more likely.I am being treated for a fungal infection that POS is known to work against.I have a hereditary sugar digestion problem.I have not taken any prohibited medications recently.I have or will have a central line placed for IV treatments.I have a history of serious heart rhythm problems or recent heart attack.I have serious liver problems.I have a confirmed fungal infection diagnosed through tissue or blood tests.If you have a possible or probable invasive fungal infection, you must meet the listed criteria to be enrolled in the study.I have been diagnosed with invasive candidiasis.I have a hereditary sugar digestion problem.I have cystic fibrosis, pulmonary sarcoidosis, aspergilloma, or allergic bronchopulmonary aspergillosis.My body weight is at least 500 grams.I have received POS within the last 30 days.I currently have or might have COVID-19.You have had a bad reaction or allergy to any azole antifungal medication or any other ingredient in the study treatment.I am not expected to live more than 5 days due to unstable blood pressure or circulation.I have a fungal infection that hasn't improved after 30 days or more of treatment.
- Group 1: Panel B: POS PFS
- Group 2: Panel B: POS IV
- Group 3: Panel A: POS IV
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What results are anticipated from the execution of this clinical experiment?
"According to Merck Sharp & Dohme LLC, the primary outcome of this trial that will be observed from Pre-dose and 0.25 Post-infusion on Day 1; Weeks 1, 2, 4 6 9 12 is Cavg of multiple dose PFS POS (Panel B). In addition to this key measure, researchers will also review secondary metrics such as Percentage of participants with all cause mortality (ACM) [Panel B], Percentage of participants presenting a drug related Adverse Event (AE), and the portion of individuals who discontinue study therapy due to AE's postulated by investigators."
What is the participation size of this trial?
"Right. The clinical trial posted on February 22nd 2022 is still seeking participants, as indicated on the information available from clinicaltrials.gov. Forty patients need to be recruited across 5 locations and this data was last updated on November 17th 2022."
Is there current availability for participants to join this trial?
"Per the details hosted on clinicaltrials.gov, this trial is presently scouting for participants and was first posted back in February of 2022 with its most recent update occuring mid-November."
What does Posaconazole IV 6 mg/kg typically resolve?
"Posaconazole IV 6 mg/kg is the standard of care for HIV, and can be prescribed to treat candidiasis or immunocompromised patients as a prophylaxis against further fungal infections."
Am I qualified to participate in this research project?
"In order to be eligible to participate in this medical experiment, prospective patients must have a confirmed case of invasive fungal infection and fall between the ages of one day old and two years. The research team is hoping to recruit approximately 40 individuals."
Are there any further investigations into the efficacy of Posaconazole IV 6 mg/kg?
"Initially tested in 2018 at Centre Hospitalier Lyon Sud, hematology department, posaconazole IV 6 mg/kg has since been studied 37 times. Currently 9 studies are operational with a large number of them based in San Diego, California."
What potential hazard is associated with administrating Posaconazole IV 6 mg/kg to individuals?
"Although Phase 2 trials lack evidence of the efficacy, our team at Power allocated Posaconazole IV 6 mg/kg a score of two due to existing safety data."
Is this particular research endeavor enrolling elderly individuals?
"This research project has determined that eligible patients must be between 1 day old and 2 years of age. Additionally, there are 209 clinical trials for minors and 659 studies targeting older adults who exceed 65 years in age."
How many venues are facilitating this experiment?
"Apart from Rady Children's Hospital-San Diego (Site 2101) in San Diego, California, Nicklaus Children's Hospital ( Site 2109) in Miami, Florida and Driscoll Children's Hospital ( Site 2113) in Corpus Christi, Texas; this trial is also recruiting patients at five other medical centres."
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What portion of applicants met pre-screening criteria?
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