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Efficacy of levofloxacin and colistin inhalation form in treatment of pneumonia

Comparison the efficacy of adding levofloxacin and colistin inhalation form to basic regimen of colistin and meropenem in treatment of ventilator associated pneumonia (VAP) caused by multidrug resistant pathogens: a double-blind randomized clinical trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20100107003014N26
Enrollment
46
Registered
2023-11-13
Start date
2023-10-23
Completion date
Unknown
Last updated
2025-01-08

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

Conditions

Ventilator associated pneumonia (VAP) caused by multidrug resistant pathogens. Ventilator associated pneumonia

Interventions

Intervention 1: Intervention group: Inhaled colistin at a dose of 2 million units every 8 hours with ultrasound nebulizer along with meropenem infusion 1 gram every 8 hours for 3 hours and colistin in

Sponsors

Mazandaran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Age older than 18 years and less than 80 years Mechanical ventilation for more than 48 hours Pneumonia diagnosis based on the 2016 guidelines of the Infectious Diseases Society of America (IDSA) CPIS score above 6 Positive culture of sputum sample and growth of gram-negative bacteria resistant to treatment (MDR) (Acinetobacter baumannii, Pseudomonas aeruginosa, Enterobacteriaceae, etc.)

Exclusion criteria

Exclusion criteria: Pregnancy or breastfeeding History of allergy to any of the drugs Colistin, Levofloxacin and Meropenem Acute respiratory distress syndrome Pulmonary tuberculosis disease under treatment Cystic fibrosis disease Major interaction of other drugs used by the patient with levofloxacin, colistin or meropenem Baseline creatinine clearance less than 15 mL/min History of receiving antibiotics effective against MDR pathogens during hospitalization Presence of pneumonia before intubation

Design outcomes

Primary

MeasureTime frame
Average CPIS score reduction in two groups. Timepoint: days 1, 5, 7 (or stop intervention day). Method of measurement: CPIS scoring table.

Secondary

MeasureTime frame
The incidence of acute kidney injury (AKI) in patients of two groups during treatment according to the KDIGO definition, defined as increase in serum creatinine of 0.3 mg/dl or more within 48 hours or an increase in serum creatinine of = 1.5 times. Timepoint: Days 1, 3, 5 and 7 of intervention. Method of measurement: Blood sample sent to the laboratory.;Registration of bronchospasm complication occurred during treatment in two groups of patients. Timepoint: During the intervention. Method of measurement: Airway resistance in the ventilator.;Improvement rate in compliance and resistance of the respiratory tract in patients of two groups. Timepoint: Days 1, 3, 5 and 7 of intervention. Method of measurement: Ventilator data and calculation according to the formula.;Mortality rate of patients in two groups until the duration of hospitalization in ICU. Timepoint: During the intervention up to the duration of ICU stay. Method of measurement: Patient database.;The 28-day mortality rate of patients in two groups. Timepoint: 28 days after pneumonia caused by mechanical ventilation. Method of measurement: Patient database.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShahram Ala

Mazandaran University of Medical Sciences

sala@mazums.ac.ir+98 11 3354 3083

Outcome results

None listed

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