Comparison of intravenous colistin plus nebulized colistin against intravenous ampicillin-sulbactam plus nebulized colistin in treating ventilator associated pneumonia caused by Acinetobacter baumannii

The efficacy and safety of intravenous colistin plus nebulized colistin against intravenous ampicillin-sulbactam plus nebulized colistin in treating ventilator associated pneumonia caused by Acinetobacter baumannii

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20120703010178N18

Enrollment

Registered

2019-03-13

Start date

2019-03-09

Completion date

Unknown

Last updated

2019-03-25

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 Acinetobacter baumannii. Pneumonia due to other aerobic Gram-negative bacteria

Interventions

Intervention 1: Intervention group: intravenous ampicillin sulbactam 6 g every 6 hours plus nebulized colistin 2 mIU every 8 hours. Intervention 2: Control group: intravenous colistin 9 mIU stat then

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Participant with endotracheal intubation days > 48 hours Pneumonia diagnosis as clinical features (which include the new onset of fever (T > 38), purulent sputum, leukocytosis or leukopenia (WBC > 11000 cells/mm3 or ?10?^5 CFU/ml) and radiographic evidences (new lung infiltrates) Sputum culture of Acinetobacter baumannii

Exclusion criteria

Exclusion criteria: History of hypersensitivity reactions to beta-lactam antibiotics or colistin Have received effective antibiotics for this episode of ventilator associated pneumonia for more than 72 hours before study medication administration Patients on dialysis Immunodeficiency (HIV with CD4 < 200 cells/mm3, ANC < 500/mm3? leukemia, lymphoma, chemotherapy within the last 3 weeks) Sever Acute respiratory distress syndrome (PaO2/Fio2 < 100) Endobronchial obstruction such as stenosis or mass in the endobronchial Sever bronchospasm Lung abscess Empyema Chest trauma Co-infection in another organs Comorbidities: cystic fibrosis? myasthenia or atelectasis Pregnancy and lactation

Design outcomes

Primary

Measure	Time frame
Microbiological evaluation. Timepoint: Before intervention and 4, 7 , 10 days after intervention. Method of measurement: Negative sputum culture for Acinetobacter.	—

Secondary

Measure	Time frame
Clinical signs evaluation. Timepoint: 4, 7 , 10 days after intervention. Method of measurement: Removing clinical and improving radiological manifestations - Successful weaning from ventilator between days 5 to 14 - Negative sputum culture for acinetocanter.;Side effects evaluation. Timepoint: Daily and until antibiotics are given. Method of measurement: Laboratory measurements Cr.;Procalcitonin level evaluation. Timepoint: before intervention and 4, 7 , 10 days after intervention. Method of measurement: Laboratory scaling.	—

Measure

Time frame

Clinical signs evaluation. Timepoint: 4, 7 , 10 days after intervention. Method of measurement: Removing clinical and improving radiological manifestations - Successful weaning from ventilator between days 5 to 14 - Negative sputum culture for acinetocanter.;Side effects evaluation. Timepoint: Daily and until antibiotics are given. Method of measurement: Laboratory measurements Cr.;Procalcitonin level evaluation. Timepoint: before intervention and 4, 7 , 10 days after intervention. Method of measurement: Laboratory scaling.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Sistanizad

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