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The Role of Aerosolized Colistin in the Treatment of Ventilator-associated Pneumonia, Caused by Multidrug-resistant Gram-negative Bacteria

Evaluation of Aerosolized (AS) Colistin as Adjunctive Treatment Versus Intravenous Colistin Alone in the Treatment of Ventilator-associated Pneumonia (VAP) Caused by Multidrug-resistant Gram-negative Bacteria

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20151227025726N9
Enrollment
34
Registered
2018-08-15
Start date
2016-04-04
Completion date
Unknown
Last updated
2018-09-11

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

Conditions

Ventilator-associated Pneumonia (VAP). Bacterial pneumonia, not elsewhere classified

Interventions

Intervention 1: Intervention group: Received IV colistin (Colistimethate Sodium Injection, powder for solution parenteral 1000000 [IU] that belongs to Forest Laboratories Uk) based on Glomerular Filtr
AS colistin was prescribed only for a period of seven days (OMRON Mesh Nebulizer Model NE-U22). To prevent bronchospasm caused by nebulized colistin, patients were premedicated with salbutamol prior t

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Age above 18 years Antibiogram of positive culture that is sensitive to Colistin and resistant to all other antibiotics The new continuous pulmonary secretions based on lung radiography among patients who are received mechanical ventilation for at least 48 hours Fever above 38ºC without any specific reason White Blood Cell number more than 12000 cells or less than 4000 cells in each milliliter Purulent tracheal secretions

Exclusion criteria

Exclusion criteria: Pregnancy Breastfeeding Septic shock

Design outcomes

Primary

MeasureTime frame
The correlation between antibiotic therapy initiation and the time of negative procalcitonin (PCT) test. Timepoint: Days of 0, 3, 5, 7 after antibiotic initiation. Method of measurement: Immunochromatographic test (PCT-Q).;The correlation between antibiotic therapy initiation and the time of negative sputum culture. Timepoint: Days of 0, 4, 7 after antibiotic initiation. Method of measurement: Sputum culture.

Secondary

MeasureTime frame
Duration of ICU stay. Timepoint: Daily. Method of measurement: By the date of admission and discharge mentioned in Clinical records.;Time of fever discontinuation. Timepoint: Every other day. Method of measurement: Thermometer.;The correlation between antibiotic therapy initiation and the reduction of WBC. Timepoint: Every other day. Method of measurement: Hematologic test.;The correlation between antibiotic therapy initiation and improvement of PaO2/FiO2. Timepoint: Every other day. Method of measurement: By arterial and venous blood gasses (ABG and VBG).;Chest X-Ray changes. Timepoint: Every other day. Method of measurement: By chest x-ray radiography.;Improvement of Clinical Pulmonary Infection Score (CPIS). Timepoint: Every other day. Method of measurement: BY CPIS score.;All the adverse effects associated with the use of colistin including bronchospasm, neurotoxicity, and hypersensitivity reactions. Timepoint: Daily. Method of measurement: Clinical records.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFaezeh Feizabadi

Shahid Beheshti University of Medical Sciences

faezehfe@gmail.com+98 21 2230 8287

Outcome results

None listed

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