Impact of Plasma Levels of Colistin in Patients with Carbapenem Resistant Acinetobacter baumannii Infection, prospective, observational study

Not Applicable

Recruiting

• Conditions: Certain infectious and parasitic diseases

• Registration Number: KCT0001520
• Lead Sponsor: Dongguk University Ilsan Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

(1) All adult patients (aged =18 years)
(2) Microbiological evidence (sputum, urine, blood) of infection due to carbapenem-resistant Acinetobacter baumannii during hospitalization
(3) Intravenous Colistimethate sodium treated patient with Acinetobacter baumannii infection who fulfill the above criteria
(4) Patients who agree to the gathering clinical information by means of an informed consent

Exclusion Criteria

(1) Pregnancy and lactating women
(2) Patients receiving Colistimethate sodium therapy for <48 hours
(3) Patient of chronic renal disease defined as a Creatinine clearance <10 mL/min, Or requirement for peritoneal or hemo-dialysis or hemofiltration
(4) Known hypersensitivity to Colistimethate sodium
(5) Receiving intravenous colistin therapy within the past 30 days
(6) Patients treated with nebulized Colistimethate sodium

Study & Design

• Study Type: Observational Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in plasma drug concentration between patients with nephrotoxicity and those without

Secondary Outcome Measures

Name	Time	Method
Difference in plasma drug concentration between patients showing clinical cure or improvement and those of treatment failure;Difference in plasma drug concentration according to microbiological response;Difference in plasma drug concentration according to in-hospital mortality;Difference in plasma drug concentration according to the RIFLE Criteria for nephrotoxicity;Nephrotoxicity and associated factors;Other adverse effect: plasma drug concentration between patients with abnormality of liver function, thrombocytopenia and neurotoxicity