A clinical trial to study the effect of nebulization of Colistin or Amikacin for prevention of ventilator-associated pneumonia in patients requiring ventilatory support in intensive care unit.

Effect of prophylactic nebulization of Colistin versus Amikacin on the incidence of ventilator-associated pneumonia in an intensive care unit setting with prevalent multidrug-resistant bacteria: A prospective double-blind randomized placebo-controlled trial. - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/06/068660

Enrollment

156

Registered

2024-06-11

Start date

Unknown

Completion date

Unknown

Last updated

2024-06-24

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

Conditions

Health Condition 1: J22- Unspecified acute lower respiratory infection

Interventions

Intervention1: Nebulization with colistin: The allotted patients will receive nebulization with colistin (colistimethate sodium, 1.5M IU, diluted in water for injection) once a day for 3 days prepar

Eligibility

Inclusion criteria

Inclusion criteria: Patients requiring mechanical ventilation for more than 72 hours.

Exclusion criteria

Exclusion criteria: Grossly purulent sputum or pneumonia on admission; new and persistent infiltrates on chest radiography within 48 hours from admission. Severe chronic obstructive pulmonary disease (COPD) or preexisting lung disease requiring long-term inhalation drug therapy. Long-term therapy with corticosteroids or immunosuppressive drugs, human immunodeficiency virus infection, cancer. Colonization or infection with a strain resistant to colistin and amikacin on admission. Acute kidney injury on the day of inclusion. Patients undergoing renal replacement therapy or for whom a decision had been made to initiate renal replacement therapy can be included whatever the KDIGO stage. Chronic kidney failure. Pregnancy and breastfeeding women. Allergy to colistin or amikacin. Myasthenia gravis.

Design outcomes

Primary

Measure	Time frame
To compare the incidence of VAP at Day 14Timepoint: At Day 14	—

Secondary

Measure	Time frame
To compare the incidence of VAP at day 28. Comparison of VAP incidence due to organisms with in vitro susceptibility to study drug. Ventilator associated events comprising ventilator-associated conditions. Clinical pulmonary infection score evolution after randomization. The number of antibiotic-days (the sum of the number of systemic antibiotic treatments received each day). Duration of mechanical ventilation from randomization to day 28. Duration of ICU stay and hospital stay from randomization to day 28. Evaluation of nebulization safety and side effects. ICU-acquired infection with antibiotic-resistant bacteria, culture-confirmed urinary tract infections, blood stream infection, catheter-related blood stream infection, soft tissue infection, and intra-abdominal infection. Timepoint: At day 28	—

Measure

Time frame

To compare the incidence of VAP at day 28. Comparison of VAP incidence due to organisms with in vitro susceptibility to study drug. Ventilator associated events comprising ventilator-associated conditions. Clinical pulmonary infection score evolution after randomization. The number of antibiotic-days (the sum of the number of systemic antibiotic treatments received each day). Duration of mechanical ventilation from randomization to day 28. Duration of ICU stay and hospital stay from randomization to day 28. Evaluation of nebulization safety and side effects. ICU-acquired infection with antibiotic-resistant bacteria, culture-confirmed urinary tract infections, blood stream infection, catheter-related blood stream infection, soft tissue infection, and intra-abdominal infection. Timepoint: At day 28

—

Countries

India

Contacts

Public ContactDr Ankila Gupta

All India Institute of Medical Sciences, Jodhpur

drmsadik@gmail.com9466380301

Outcome results

None listed

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