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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.

CEFRTRIAXONE, SULBACTUM, DISODIUM EDTA & COLISTIN VERSUS MEROPENEM & COLISTIN FOR THE TREATMENT OF MULTIDRUG RESISTANT- VENTILATOR ASSOCIATED PNEUMONIA : A RANDOMIZED CONTROL STUDY

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/05/053239
Enrollment
60
Registered
2023-05-30
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

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: Injection Ceftriaxone, Sulbactum , Disodium EDTA and Colistin to the patients with Multi drug resistant ventilator associated pneumonia: Injection Ceftriaxone, Sulbactum , Disodium ED

Sponsors

SGRD Hospital
Lead Sponsor

Eligibility

Inclusion criteria

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 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

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

Design outcomes

Primary

MeasureTime frame
Clinical, Bacteriological and safety response of the patientsTimepoint: 1st day of beginning of antibiotics then 3rd,5th,7th,10th and 14th day

Secondary

MeasureTime frame
Cost effectiveness in terms of money spent on antibioticsTimepoint: 10th day and 14th day

Countries

India

Contacts

Public ContactDr Jonny Dhawan

Sri Guru Ram Das Institute of Medical Sciences and Research

jonnydhawan074@gmail.com9915926761

Outcome results

None listed

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