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

Mahidol University

Status and phase: Unknown; Phase 4

Conditions: Hospital Infection

Treatments: Drug: Polymyxin B

Study type: Interventional

Funder types: Other

Identifiers

NCT02328183

568/2557(EC4)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Polymyxin B

Experimental group

Description:

Polymyxin B 1.5-2.5 mg/kg/day intravenous q 12 hrs duration 7-14 days

Treatment:

Drug: Polymyxin B