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

Hospital Infection Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hospital Infection
• Infection

• NCT number: NCT02328183
• Study type: Interventional
• Source: Mahidol University
• Contact: Thundon Ngamprasertchai, MD.
• Phone: 66850887736
• Email: thundon_ngamprasertchai@hotmail.com
• Status: Recruiting
• Phase: Phase 4
• Start date: December 2014
• Completion date: November 2015