Efficacy and safety of a colistin loading dose, population pharmacokinetic-pharmacodynamic profiles and bacterial clearance rate in critically ill patients with extensively drug-resistant Acinetobacter baumanii (XDRAb) infections

Phase 4

• Conditions: Infections with extensively drug resistant Acinetobacter baumanii; Infection - Studies of infection and infectious agents

• Registration Number: ACTRN12613000862741
• Lead Sponsor: Helmi B Sulaiman

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1)Age 18 and above

2)Patients with a first episode of culture proven XDRAb from blood, CSF, sputum and tracheal aspirate samples.

3)Receive colistin treatment for more than 72 hours

4)Fulfill diagnostic criteria for ventilator-related pneumonia, hospital-acquired pneumonia, bacteremia (catheter- and non catheter-related), and meningitis or CSF infections, as defined in accordance with IDSA guidelines

Exclusion Criteria

1) Pregnant
2) Breastfeeding
3) ALT/AST more than 8 times upper limit of normal
5) Allergy to colistin or its prodrug

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
30-day mortality rate. We will use crude mortality data rather than infection specific mortality data for the 30 day mortality[Assessed at the 30th day after treatment commencement ]

Secondary Outcome Measures

Name	Time	Method
ICU length of stay <br><br>[We will review the patient medical record to ascertain the length of stay post colistin commencement];Hospital length of stay<br>[We will review the patient medical record to ascertain the length of stay post colistin commencement];PKPD parameters attainment[For PKPD parameters: the blood will be collected on day 1 and day 3, and the modelling of colistin will be done to ascertain the serum levels of colistin in both the study arms. Liquid chromatography mass spectrometry machine will be used for this ];bacterial clearance (using PCR technique)[For RT PCR bacterial clearance: Day 0,1,2,3 and the final day of the treatment. An RT PCR machine will be used for this]