NCT02328183

Efficacy of Polymyxin B Against Infections Caused by Extensively Drug-resistant (XDR) Gram-Negative Bacteria

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hospital Infection

Interventions

Type	Name	Description
DRUG	Polymyxin 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

Timeline

• Start date: 2014-12-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2014-12-31
• Last updated: 2015-09-01

Locations

1 site across 1 country: Thailand