The objective of the study is to evaluate the efficacy of Polymyxin B for treatment Gram negative bacterial infection. The hypothesis of study is Polymyxin B would be the new antibacterial agents for Thai Gram negative infected patients in case of desirable outcomes and minimal side effects.
* Investigator is notified by doctors who take care of gram negative infected patients. * Investigator inform patient or their relatives about all topics in project, eligible criteria, method, material and monitoring treatment. * After patient or their relatives are appreciated to join this project, investigator collect data in case record form;electronics form, then implement the drug. * Duration of treatment is determined by site and severity of infection, approximately 7-14 days. * Sample size calculation, by prevalence formula, we estimate the mortality rate about 50 %, deviation 10 %,and 2-sided 95% Confidence interval, therefore,97 persons * We estimate gather data about 100 persons. * Statistical descriptive analysis for descriptive data. * During the study is performing, all unexpected adverse event definitely report to Siriraj institutional Review Board immediately, in addition to subjects or their relatives.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
administrate drug by 0.75-1.25 mg/kg/dose intravenously q 12 hrs both saline and dextrose solution can be dissolved duration 7-14 days
Siriraj hospital
Bangkok, Bangkok, Thailand
RECRUITINGmortality rate
mortality rate of gram negative bacteria infected patients receiving Polymyxin B at day 28 after enrollment
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
adverse drug reactions
we assess adverse drug reactions in 2 aspects; nephrotoxicity and neurotoxicity
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
microbiological clearance
we perform culture and staining to assess bacterial clearance after apply the study drug every 3 days until culture is negative
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Peak Plasma Concentration (Cmax) of polymyxin B
we do the blood test for drug level at before the third date dose then 1,2,4 hours after administration of the polymixin B and before the fourth dose.
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
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