Efficacy of Polymyxin B Against Infections Caused by Extensively Drug-resistant (XDR) Gram-Negative Bacteria
- Registration Number
- NCT02328183
- Lead Sponsor
- Mahidol University
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Polymyxin B Polymyxin B Polymyxin B 1.5-2.5 mg/kg/day intravenous q 12 hrs duration 7-14 days
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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
Trial Locations
- Locations (1)
Siriraj hospital
🇹ðŸ‡Bangkok, Thailand