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Which is better in between Nebulized Polymyxin E and Nebulized Amikacin for the prevention of ventilator-associated pneumonia

Nebulized Polymyxin E and Amikacin for the prevention of ventilator-associated pneumonia-A double-blind randomized clinical study - Nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/070824
Enrollment
276
Registered
2024-07-18
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Health Condition 1: J958- Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified

Interventions

Intervention1: Nebulized Polymyxin E: Polymyxin E 5.5 mg/kg/day for 3 consecutive days in the nebulized form .The drugs will be given twice daily for 3 consecutive days with the help of vibrating mesh

Sponsors

Uttarpradesh University of medical sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients who are expected to be on mechanical ventilation for at least 72 hours.

Exclusion criteria

Exclusion criteria: 1. Patients who are already on mechanical ventilation for more than 96 hours. 2.Patients who are already diagnosed with or a suspected case of pneumonia 3.Patient with chronic kidney disease 4. Positive pregnancy test at the time of inclusion 5. Patient scheduled for extubation within the next 24 hours 6. Patient known to be allergic to aminoglycosides or polypeptide antibiotics at the time of inclusion. 7. Patients who are already on systemic aminoglycoside or polypeptides antibiotics 8.Patients who are tracheostomized.

Design outcomes

Primary

MeasureTime frame
To compare the first episode of VAP in between the two groups from randomization to Day 28 on the basis of Clinical Pulmonary Infection Score(CPIS),Timepoint: 28 Days

Secondary

MeasureTime frame
To compare the median number of days from randomization to first successful spontaneous breathing trial.Timepoint: 28 Days;Adverse reaction in between the two groups due to nebulization.Timepoint: 28 Days;To compare the median length of stay in days (ICU and Hospital).Timepoint: 28 Days;To compare the median number of days on mechanical ventilation from randomization to Day 28.Timepoint: 28 Days

Countries

India

Contacts

Public ContactHarish Kumar

Uttarpradesh university of medical sciences

harishthedoc@outlook.com9454152626

Outcome results

None listed

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