Critically ill patients who suspected Gram negative bacteria infection. Pharmacokinetic/Pharmacodynamic Study,
Conditions
Interventions
Blood samples will collect from an indwelling arterial cannula before the drug administration and at 30 min,
1 h,
2 h,
4 h,
6 h,
8 h,
and 12 h after administration of biapenem and fosfomycin sodium
Experimental Drug
Biapenem and Fosfomycin sodium
Sponsors
Faculty of Graduate Studies, Mahidol University
Thai Meiji Pharmaceutical Co.,
Ltd
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug level within 24 hour after drug administration HPLC | — |
Secondary
| Measure | Time frame |
|---|---|
| Population Pharmacokinetic parameter with 1 month after recieve drug level NONMEM program | — |
Countries
Thailand
Contacts
Public ContactJantana Houngsaitong
Faculty of Pharmacy, Mahidol university
Outcome results
None listed