CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 8 enrolled
Drug / intervention
Posaconazoledrug
Likely dose
Posaconazole 300mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02968134
NCT02968134Phase 4Completed

Single Dose Population Pharmacokinetics of Intravenous Posaconazole in Critically Ill Patients

Royal Brisbane and Women's Hospital·interventional·Posted Nov 18, 2016·Updated Sep 21, 2018

In Brief

A Phase 4 clinical trial evaluating Posaconazole for Systemic Fungal Infections. Completed, enrolled 8 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 18, 2016
Enrollment StartJan 16, 2017
Primary CompletionMay 21, 2017
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 9.6 years ago

Interventions

Posaconazoledrug

A single dose of 300mg intravenous posaconazole will be administered and blood samples will be taken prior to start of infusion, at 15,45,75minutes, 3,5,8,12,18,24,30,36 and 48 hours.