comparison of newer and higher dose antibiotics combination therapy with old and standard antibiotics combination therapy in critically ill patients who are carbapenem resistant enterobacteriaceae (CRE)

Phase 4

Not yet recruiting

• Conditions: Abnormal finding of blood chemistry, unspecified,

• Registration Number: CTRI/2022/09/045736
• Lead Sponsor: Department of Anaesthesiology and Critical and Care Jawaharlal Nehru Medical College AMU Aligarh

Brief Summary

Carbepenem resistant enterobacteriaceae (CRE) , a major resistance concern during last decade and become the important focus of infection .

New and effective therapeutic strategies developed for the treatment of CRE positive patients like to increasing the doses of anti CRE agents and to combine these anti CRE infections .



AIM OF THE STUDY :

PRIMARY OBJECTIVE : see the SOFA score changes at zero hour and 48hours of starting the treatments



SECONDARY OBJECTIVE: See the microbiological eradication and mortality within 5th day starting the antibiotics.



METHODS AAND MATERIALS: Study will be conducted on 80 patients admitted in the icu/ccw of JNMCH,AMU,ALIGARH

Group A will receive meropenem(1gm 3 times daily ) and colistin (9MIU loadind followed by 2-3 MIU) while group B receive high dose tigecycline (200mg loadind followed by 100mg 2 times a day) and colistin



RESULT: To see changes in SOFA SCORE AFTER 48 HOURS OF STARTING THE ANTIBIOTICS COMBINATION AND SEE THE ERADICATION AND MORTALITY WITHIN 5TH DAY .

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-09-16
• Study Start: 2022-09-26

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• 1.Patient having sepsis and SOFA score of 2 or more than 2 at the time of admission in icu/ccw.
• 2.There should be an isolates of carbapenem resistant enterobacteriaceae (CRE) positive either from Blood, tracheal aspirates, urine or abdominal pus culture.
• 3.Patient on any empirical antibiotics except current combination therapy .

Exclusion Criteria

• 1.Patient who is not having sepsis and having SOFA score of less than 2.
• Non Carbapenem resistant enterobacteriaceae (CRE) patients.
• 3.Patient who expire within 48 hours of starting the combination therapy.
• 4.Patient having sensitivity to the drug use .
• 5.Covid -19 positive patients.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To see the changes in sequential organ failure assessment (SOFA) score at zero hour and after 48 hours of starting combination therapies meropenem plus colistin and high dose tigecycline plus colistin in carbapenem resistant enterobacteriaceae positive cases.	2 days

Secondary Outcome Measures

Name	Time	Method
To see the microbiological eradication of carbapenem resistant enterobacteriaceae on 5th day and to report any mortality within 5 days of starting the antibiotics combination therapies .	5 days

Trial Locations

Locations (1)

Jawaharlal Nehru Medical college, AMU; 🇮🇳 Aligarh, UTTAR PRADESH, India

Jawaharlal Nehru Medical college, AMU

🇮🇳Aligarh, UTTAR PRADESH, India

JAHANARA

Principal investigator

08755671505

Jahanara627@gmail.com