The Pharmacokinetic/Pharmacodynamic Study of Biapenem combination with Fosfomycin sodium against Acinetobacter baumannii infection in Thai Critically Ill
Phase 4
- Conditions
- Critically ill patients who suspected Gram negative bacteria infection.Pharmacokinetic/Pharmacodynamic Study,Acinetobacter baumannii,Critically Ill patients
- Registration Number
- TCTR20180222002
- Lead Sponsor
- Faculty of Graduate Studies, Mahidol University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Critically ill patients who (i) suspected Gram negative bacteria infection (ii) will prescribe iv. biapenem and fosfomycin sodium by the treating physician
The severity of illness of each patient describe by using the acute physiology and chronic health evaluation II (APACHE II) more than 15 and sequential organ failure assessment (SOFA) scores more than 2 on day 1 of treatment.
Exclusion Criteria
Patients meeting any of the following criteria will be excluded: (i) age less than 18 years, (ii) contraindication with biapenem, (iii) history of biapenem hypersensitivity (iv) pregnancy or lactation, and (v) consent not obtained.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Drug level within 24 hour after drug administration HPLC
- Secondary Outcome Measures
Name Time Method Population Pharmacokinetic parameter with 1 month after recieve drug level NONMEM program