Hospital Infection
Conditions
Keywords
polymyxin B, carbapenem resistant bacteria
Brief summary
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.
Detailed description
* 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.
Interventions
DRUGPolymyxin B
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
Sponsors
Mahidol University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-75 year-old * The infection caused by carbapenem-resistant (CR) Enterobacteriaceae, CR P.aeruginosa or CR A. baumannii which susceptible to colistin * The duration of treatment approximately between 7-14 days * Kidney function, according to Kidney Disease Improving Global Outcomes (KDIGO) classification, should less than stage 4 and no replacement therapy in all modality. * The patients are anticipated to live more than 48 hrs after participation. * In case of Colistin administration beforehand, it should not exceed 24 hrs. * All of participants should be willing to join this project.
Exclusion criteria
* Pregnancy and lactation * End stage renal disease who take renal replacement therapy * Any type of Neuromuscular disease * Body mass index exceed 30 * Infection that require treatment more than 14 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mortality rate | participants will be followed for the duration of hospital stay, an expected average of 4 weeks | mortality rate of gram negative bacteria infected patients receiving Polymyxin B at day 28 after enrollment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| adverse drug reactions | participants will be followed for the duration of hospital stay, an expected average of 4 weeks | we assess adverse drug reactions in 2 aspects; nephrotoxicity and neurotoxicity |
| microbiological clearance | participants will be followed for the duration of hospital stay, an expected average of 4 weeks | we perform culture and staining to assess bacterial clearance after apply the study drug every 3 days until culture is negative |
| Peak Plasma Concentration (Cmax) of polymyxin B | participants will be followed for the duration of hospital stay, an expected average of 4 weeks | 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. |
Countries
Thailand
Contacts
Primary ContactThundon Ngamprasertchai, MD.
Backup ContactAdhiratha Boonyasiri, MD
Outcome results
None listed