Phase 4
N=8
Single Dose Population Pharmacokinetics of Intravenous Posaconazole in Critically Ill Patients
Systemic Fungal Infections
Bottom Line
View on ClinicalTrials.gov: NCT02968134 ↗Enrolled (actual)
8
Serious AEs
12.5%
Results posted
Jul 2018
Primary outcome: Primary: Posaconazole Exposure Described as Area Under the Total Plasma Concentration-time Curve From Time Zero to Infinity After a Single Dose — 17932 ng*h/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Posaconazole (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Royal Brisbane and Women's Hospital
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Posaconazole Exposure Described as Area Under the Total Plasma Concentration-time Curve From Time Zero to Infinity After a Single Dose |
17932 | — |
| PRIMARY Posaconazole Exposure Expressed as Area Under the Unbound Concentrations-time Curve From Time Zero to Infinity |
97.2 | — |
Summary
The purpose of this study is to try to find out how critically ill patients receiving the anti fungal medication, posaconazole, process it in their body. Investigators would like to study if the recommended doses of posaconazole achieve adequate concentrations in the patients blood to treat fungal infections.The disease process in critically ill patients can profoundly influence the concentration of anti fungal medication in the blood. The process by which a drug travels through the body in blood, how it is broken down and removed by the body is called pharmacokinetics (PK).
This information is important to know because if antifungal levels are low in the blood, the fungal infection has an opportunity to become resistant to the antifungal medication which can lead to the medication being less effective against the fungal infection potentially exposing future patients with infection to a limited range of effective antifungals.
Investigators can measure the PK by taking blood samples at specific times after the anti fungal medication is given.
This study will enroll 8 patients who are admitted to the intensive care unit and are being treated with an antifungal medication for a fungal infection. Patients will be consented and given a single dose of posaconazole and serial blood samples will be collected just prior to the dose and at 15, 45,75 minutes during the infusion and at 3, 5, 8, 12, 18, 24, 30 36 and 48 hours . Information about the patients stay in the ICU will also be collected including blood pressure, temperature, blood test results.
Eligibility Criteria
Inclusion Criteria
- Age greater than 18 years
- Admission for ICU care
- The presence of suspected or confirmed fungal infection requiring systemic antifungal therapy
- Presence of central venous access for drug administration
Exclusion Criteria
- Age < 18 years
- Pregnancy
- Prescription of drugs that are known to interact with posaconazole
- Oral posaconazole use within the last two week prior to enrolment
- Documented history of drug reaction to the triazole antifungal medications
Data sourced from ClinicalTrials.gov (NCT02968134). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.