Single Dose Population Pharmacokinetics of Intravenous Posaconazole in Critically Ill Patients

NCT02968134 | Completed Phase 4 Results

• 1 other identifier: HREC/16/QRBW/377
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Systemic Fungal Infections

Outcome Measures

Primary Outcomes (2)

• Posaconazole Exposure Described as Area Under the Total Plasma Concentration-time Curve From Time Zero to Infinity After a Single Dose

  The primary outcome is plasma posaconazole exposure expressed as the area under the total plasma concentration-time curve from time zero to infinity resulting from a single dose of 300 mg of posaconazole administered intravenously.

  48 hours

• Posaconazole Exposure Expressed as Area Under the Unbound Concentrations-time Curve From Time Zero to Infinity

  This is a measure of free posaconazole ( not bound to plasma proteins) exposure in the plasma. This is an important measure of exposure because its the free concentration that distributes into targets sites of infection to produce clinical effect.

  48 hours

Study Arms (1)

Posaconazole

OTHER

The study will enrol eight patients with presumed or confirmed systemic fungal infections, who are admitted to ICU

Drug: Posaconazole

Interventions

Posaconazole DRUG

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.

Also known as: Noxafil

Posaconazole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Brisbane and Women's Hospital: lead
• The University of Queensland: collaborator

Related Publications (1)

• Sime FB, Stuart J, Butler J, Starr T, Wallis SC, Pandey S, Lipman J, Roberts JA. Pharmacokinetics of Intravenous Posaconazole in Critically Ill Patients. Antimicrob Agents Chemother. 2018 May 25;62(6):e00242-18. doi: 10.1128/AAC.00242-18. Print 2018 Jun.

  PMID: 29581122 RESULT

MeSH Terms

Interventions

posaconazole

Results Point of Contact

• Title: Prof. Jason Roberts
• Organization: The University of Queensland

j.roberts2@uq.edu.au

+61 7 3646 4108

Study Officials

• Jason A Roberts, BPharm

  Royal Brisbane and Womens Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 15, 2016
• First Posted: November 18, 2016
• Study Start: January 16, 2017
• Primary Completion: May 21, 2017
• Study Completion: May 21, 2017
• Last Updated: September 21, 2018
• Results First Posted: July 9, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share