Systemic Fungal Infections Clinical Trial
— POSAOfficial title:
Single Dose Population Pharmacokinetics of Intravenous Posaconazole in Critically Ill Patients
Verified date | August 2018 |
Source | Royal Brisbane and Women's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 8 |
Est. completion date | May 21, 2017 |
Est. primary completion date | May 21, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Royal Brisbane and Women's Hospital | The University of Queensland |
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). pii: e00242-18. doi: 10.1128/AAC.00242-18. Print 2018 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01686607 -
Short and Long-term Safety of Micafungin and Other Parenteral Antifungal Agents
|
||
Completed |
NCT00721578 -
A Study Of Indian Patients Receiving Therapy For Systemic Fungal Infections
|
N/A |