An adaptive pharmacological approach for the individualisation of voriconazole antifungal therapy
- Conditions
- Invasive fungal infectionInfections and Infestations
- Registration Number
- ISRCTN83902726
- Lead Sponsor
- niversity of Liverpool (UK)
- Brief Summary
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30670416 (added 12/06/2019)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 19
1. Patients =18 years old
2. Patients where a new course of voriconazole is indicated for prevention or treatment of an invasive fungal infection
3. Patients with sufficient venous access to enable repeated blood samples
4. Estimated creatinine clearance = 50 mL/min
5. Able to give written informed consent
6. Able to remain in the hospital for at least 5 days
7. Willing to use adequate contraception if necessary
1. Estimated creatinine clearance < 50 mL/minute
2. Use of haemodialysis or haemofiltration
3. Hepatic insufficiency (Child?s B or C)
4. Hepatitis with LFTs > three-times upper limit of normal
5. Pregnancy, breastfeeding or planning pregnancy during the study
6. Past history of intolerance to voriconazole
7. Microbiological evidence of resistance to voriconazole
8. QT prolongation (see 20.6 page 68)
9. Use of other medications that contraindicate the use of voriconazole
10. Hypersensitivity to voriconazole, its excipients or other triazole antifungal agents
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The safety and efficacy of computer software to attain pre-defined plasma concentrations of voriconazole for immunocompromised patients. Successful therapy is a trough concentration of 1-3 mg/L at the end of the 10th dosing interval on day 10.
- Secondary Outcome Measures
Name Time Method <br> 1. Toxicity of patients receiving individualised voriconazole dosing at 35 days<br> 2. Mortality of patients receiving individualised voriconazole dosing at 35 days<br>