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Comparison of the effectiveness and safety of the Intravenous colistin alone vs. intravenous colistin plus inhaled colistin in patients on ventilator having pneumonia

Efficacy and safety of intravenous colistin plus nebulized colistin versus intravenous colistin alone in patients with clinically suspected ventilator-associated pneumonia: a single-centre prospective cohort study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/11/076911
Enrollment
66
Registered
2024-11-18
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Health Condition 1: J188- Other pneumonia, unspecified organism

Interventions

Intervention1: Intravenous colistin plus Nebulized colistin: Intravenous colistin plus nebulized colistin along with STANDARD OF CARE(SOC) will be given in study cohort Control Intervention1: Intraven

Sponsors

All India Institute of Medical Sciences Raipur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged 18 years or older patients admitted to critical care unit for more than 48 hours patients clinically suspected with ventilator associated pneumonia patients who will be receiving intravenous colistin and/or nebulized colistin

Exclusion criteria

Exclusion criteria: patients who will be discharged, leave against medical advise patient who are re-admitted to ICU

Design outcomes

Primary

MeasureTime frame
Clinical Improvement in terms of - 1.decreased FiO2 (20% decreases from baseline) 2.decreased PEEP (3 cm of water decrease from baseline) 3.total leukocyte count (within normal range as compared to baseline) 4. decreased secretions or decrease in number of suctioning as compared to baseline 4. procalcitonin levels less than 0.05mcg/litre or 80% decrease from baselineTimepoint: at baseline (for comparison), at end of3rd day

Secondary

MeasureTime frame
clinical improvementTimepoint: baseline, seventh day;median length of ICU StayTimepoint: date of admission in ICU & date of discharge/death/transferred out from ICU;median length of mechanical ventilationTimepoint: date of intubation & date of extubation;percentage of change in Clinical pulmonary infection score at admission & at completion of antibiotic therapyTimepoint: at admission & after antibiotic therapy is completed;all cause ICU mortalityTimepoint: between date of admission at ICU & date of discharge/death/transferred out;incidence of AKITimepoint: baseline, 3rd day & 7th day;incidence of bronchospasmTimepoint: after each instance of nebulization;culture conversion rateTimepoint: baseline & after completing antibiotic therapy

Countries

India

Contacts

Public ContactDr Nitin R Gaikwad

All India Institute of Medical Sciences Raipur

nitingaikwad2707@aiimsraipur.edu.in8518881725

Outcome results

None listed

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