Health Condition 1: Z161- Resistance to beta lactam antibiotics
Conditions
Interventions
Intervention1: Elores
: 1.5 gm twice daily intravenously
The medication is continued until the culture and sensitivity reports indicate a sterile result
Sponsors
Dr Ritesh Aggarwal
Eligibility
Inclusion criteria
Inclusion criteria: 1 Age more than 18 years male and female 2 Pneumonia or Bloodstream infection BSI or cUTI due to carbapenem resistant Enterobacteriaceae E coli Klebsiella Enterobacter or Carbapenem resistant Acinetobacter CRAB or carbapenem resistant Pseudomonas Carbapenem resistance is defined as phenotypic resistance to carbapenems Meropenem Imipenem Doripenem or Ertapenem MIC more than equal to 1 mcg/ml 3 Organism is sensitive to CSE Elores
Exclusion criteria
Exclusion criteria: 1 Polymicrobial cultures 2 Patients who received 72 hours or more of antibiotic treatment for carbapenem resistant infection within 96 hours of enrolment Ceftazidime Avibactam alone or in combination OR Polymyxin B Colistin alone or in combination OR Fosfomycin Minocycline Tigecycline Ampicillin Sulbactam alone or in combination 3 Pregnant or breastfeeding females 4 Neutropenia (TLC less than 500cells per mm3) 5 Presence of any of the following clinical syndromes due to carbapenem resistant bacteria as a pathogen which requires a duration of antibiotic more than 14 days Endocarditis Osteomyelitis Prosthetic joint infections Meningitis or other CNS infections 6 Presence of concurrent infections bacterial or fungal at any other body site 7 Refractory shock or comorbid condition such that the patient is not expected to survive more than 48 hours of eligibility assessment 8 Where the source control of infection is required catheter/device/prosthesis removal surgical procedure etc but not performed due to any reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1The number of patients with Clinical Cure in the mIIT (Population comprising patients with a properly obtained respiratory/blood/urine culture demonstrating Gram-negative pathogens susceptible for the study drugs) 2Microbiological eradication at EOT Visit. Timepoint: At the end of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 28-day all-cause mortality 2 ICU-LOS 3 Hospital LOS 4 To evaluate the safetyTimepoint: At the end of treatment | — |
Countries
India
Contacts
Public ContactDr Ritesh Aggarwal
Max Smart Super Speciality Hospital Saket
Outcome results
None listed