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)

To compare the efficacy of two combination therapies against carbapenem resistant enterobacteriaceae Meropenem plus colistin versus high dose tigecycline plus colistin in critically ill patients.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/09/045736

Enrollment

Registered

2022-09-21

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

Health Condition 1: R799- Abnormal finding of blood chemistry, unspecified

Interventions

Intervention1: High dose Tigecycline and colistin: GROUP B : High dose Tigecycline (200mg loading dose followed by 100mg twice daily maintenance dose) plus colistin(9MIU loading dose followed by

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.Timepoint: 2 days	—

Secondary

Measure	Time frame
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 .Timepoint: 5 days	—

Countries

India

Contacts

Public ContactJAHANARA

Jawaharlal Nehru Medical College,Aligarh Muslim University,Aligarh

drabunadeem@gmail.com9837757772

Outcome results

None listed

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