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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20120703010178N15

Enrollment

Registered

2018-04-23

Start date

2017-12-01

Completion date

Unknown

Last updated

2018-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilator-Associated Pneumonia due to multi drug resistant Acinetobacter. Pneumonia due to other aerobic Gram-negative bacteria

Interventions

Intervention 1: Intervention group: Amp Ampicillin-sulbactam 6g 4 times a day with Amp Levofloxacin 750mg Daily. Intervention 2: Control group: Amp Colistin 9000000 unit stat and then Amp Colistin 450

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
30% Decreasing in CPIS score. Timepoint: Before intervention and 4, 7 , 10 days after intervention. Method of measurement: CPIS score.	—

Secondary

Measure	Time frame
Evaluation of ESR & CPR change in infection treatment. Timepoint: before intervention and 4, 7 , 10 days after intervention. Method of measurement: Laboratory scaling.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Sistanizad

Department of Clinical Pharmacy, Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences

sistanizadm@sbmu.ac.ir+98 218800087

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026