Study to evaluate clinical effects of Polymyxins and Ceftazidime-Avibactum in critical patients and evaluate which group has better outcomes (CoP CAcRE)

Not yet recruiting

• Conditions: Severe sepsis,

• Registration Number: CTRI/2023/10/058761
• Lead Sponsor: Research institution

Brief Summary

Carbapenem-resistant Enterobacteriaceae (CREs) have been regarded as one of fatal medical threats to the public health based on World Health Organization priority list of antibiotic resistant bacteria.The pharmacotherapy of carbapenem-resistant Enterobacteriaceae (CRE) infections is challenging and has typically included multiple antibiotics. Ceftazidime/avibactam is a new β-lactam/β-lactamase inhibitor combination recently approved for the treatment of CRE and has proved efficacious.Recent surge in CRE also has led re-introduction of Polymyxins as one of limited treatment options. Clinical studies about comparing clinical efficacy of CAZ/AVI and polymyxins-based therapeutic regimens in CRE infections in critically ill patients are still few. Hence, we designed a study to compare clinical outcomes of CAZ/AVI with Polymyxins in critically ill patients with CRE infections when used as monotherapy or in combination with other antibiotics depending upon the microbiological data. This prospective observational comparative study would be carried out in Critical care department of Army Hospital Research and Referral, New Delhi over a period of one and half years Total of 60 patients with age ≥18 years, with features of Sepsis  and microbiological culture confirmed CRE infection (Pulmonary and Blood stream)  and who have received CAZ/AVI or Polymyxins for at least 72 hours would be included in the study. Various demographic, clinical, lab parameters would be recorded daily  up to 72 hours of treatment cessation or duration of therapy.Primary Objective is to determine and compare Clinical success rate between two groups of patients and secondary objectives include  to determine and compare length of ICU stay between two groups of patients ,to determine and compare bacteriological clearance within 72 hours of antibiotic initiation and evaluation of side effects between two groups.Statistical tests will be applied as follows1.Quantitative variables will be compared using Unpaired t-test/Mann-Whitney Test (when the data sets were not normally distributed) between the two groups. 2.Qualitative variables will be compared using Chi-Square test /Fisher’s exact test. A p value of <0.05 will be considered statistically significant. The data will be entered in MS EXCEL spreadsheet and analysis will be done using Statistical Package for Social Sciences (SPSS) version 21.0.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-10-16
• Study Start: 2023-10-28

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1.Critically ill patients admitted in ICU with features of Sepsis 2.Microbiological culture confirmed CRE infection (Pulmonary and Blood stream) 3.Patients who have received CAZ/AVI or Polymyxins for at least 72 hours.

Exclusion Criteria

1.Polymicrobial cultures 2.Patients who have already received CAZ/AVI or Polymyxins before ICU admission 3.Patients with CKD 4.Patients with chemotherapy or immunosuppressant therapy in last three months •Post organ transplant patients.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine and compare Clinical success rate between two groups of patients	14 days

Secondary Outcome Measures

Name	Time	Method
1.To determine & compare length of ICU stay between two groups of patients	2. To determine and compare bacteriological clearance within 72 hours of antibiotic initiation

Trial Locations

Locations (1)

army hospital Research and Referral, Delhi,110010; 🇮🇳 South, DELHI, India

army hospital Research and Referral, Delhi,110010

🇮🇳South, DELHI, India

Dr Neha Bhardwaj

Principal investigator

09540840669

gaurinehabhardwaj@gmail.com