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A randomized control study to evaluate the effectiveness of ceftriaxone, sulbactum, disodium EDTA & colistin in comparison to meropenem & colistin for the treatment of multidrug resistant ventilator associated pneumonia.

Phase 4
Conditions
Health Condition 1: J22- Unspecified acute lower respiratory infection
Registration Number
CTRI/2023/05/053239
Lead Sponsor
SGRD Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1) Age > 18 years

2) Primary diagnosis of VAP based on the the presence of ventilator associated events (VAE) which are consisted of [Ventilator associated condition (VAC)- worsened oxygenation + Increase in positive expiratory pressure by 3 cm or increase in FiO2 by 2% , Infection related ventilator associated condition (IVAC)- fever >38C or hypothermia < 36C or WBC < 4000/ > 12000 and antibiotics for least 4 days and positive microbiological result.]

3) Positive culture of MDR ( Acinetobacter baumanii, Klebsiella pneumoniae)

4) Patients who will be (meropenem and AAE resistant).

5) Hospitalization for more than 5 days.

6) Subjects with clinically significant cardiovascular, renal, hepatic, gastrointestinal conditions, neurological, psychiatric, respiratory, other severely immunocompromised, hematological or malignant disease, history of uncontrolled diabetes mellitus, HIV and hepatitis-B and other condition which may interfere with the assessment will be carefully assessed and any significant information will be recorded and reported.

Exclusion Criteria

1)Patients who will receive treatment for less than 72hrs.

2)Subjects with history of resistance to any of the investigational drugs, history of hypersensitivity, allergic response or any contraindications to penicillin, cephalosporin or carbapenem groups of drugs, history of hearing loss

3)Participation in any clinical study during data collection period.

4)Pregnant or lactating mother

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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