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Comparison of Levofloxacin/Colistin with Levofloxacin/high dose Ampicillin-sulbactam infusion in treatment of Ventilator-Associated Pneumonia due to multi drug resistant Acinetobacter

Not Applicable
Recruiting
Conditions
Ventilator-Associated Pneumonia due to multi drug resistant Acinetobacter.
Pneumonia due to other aerobic Gram-negative bacteria
Registration Number
IRCT20120703010178N15
Lead Sponsor
Shahid Beheshti University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
56
Inclusion Criteria

Participant has received mechanical ventilation for > 48 hours
Acute Physiology and Chronic Health Evaluation (APACHE) II score of more than 8
CPIS score >6
ETT culture of MDR acinetobacter (‘MDR Acinetobacter spp.’ will be defined as the isolate resistant to at least three classes of antimicrobial agents as below:all penicillins and cephalosporins (including inhibitor combinations), fluroquinolones, and aminoglycosides.)

Exclusion Criteria

History of moderate or severe hypersensitivity reactions to beta-lactam antibiotics or colistin
Kidney injury defined as GFR<30ml/min (day 0 to 3 of the study)
Have received antibiotics for this episode of ventilator-associated pneumonia for more than 96 hours before study medication administration
co-infection in another organs
Acute respiratory distress syndrome
Has any of the following conditions: chest trauma with a fracture of the sternum, ribs, or both
Has lung cancer within the last 2 years
chronic bronchitis with an increase in severity within the last 30 days
tuberculosis on treatment
suspected atypical pneumonia
cystic fibrosis and severe burns to greater than 15% of the body

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
30% Decreasing in CPIS score. Timepoint: Before intervention and 4, 7 , 10 days after intervention. Method of measurement: CPIS score.
Secondary Outcome Measures
NameTimeMethod
Evaluation of ESR & CPR change in infection treatment. Timepoint: before intervention and 4, 7 , 10 days after intervention. Method of measurement: Laboratory scaling.
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