Health Condition 1: B968- Other specified bacterial agents as the cause of diseases classified elsewhere
Conditions
Interventions
None listed
Sponsors
Global Antibiotic Research and Development Partnership GARDP
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: 1) For Part A: Patients aged >=18 years of age with proven CRE or CRPA infections admitted to an ICU and being treated with IV antibiotics. Types of infections as listed, but not exclusively: cUTI, complicated intra-abdominal infections (cIAI), acute bacterial skin and skin structure infections (ABSSSIs), hospital-acquired and ventilator-associated bacterial pneumonia (HAP/VAP), and bloodstream infections (BSIs). For Part B: Children and adults aged 2 to 99 years diagnosed with cUTI/AP caused by CRE or CRPA and needing IV antibiotics for at least 5 days as an inpatient, but not to be managed in the ICU department. 2)Informed consent from patient if able to do so or consent from the patientâ??s legal representative or parent/guardian. Patients will also consent that the microbiological isolates collected and supporting the CRE/CRPA diagnosis will be stored for further microbiological analyses. 3) Willingness to provide contact information and to be contacted for 28 days follow up.
Exclusion criteria
Exclusion criteria: 1) Previously enrolled in this study (if readmitted and restarted on antibiotics before the 28-day follow-up limit is reached). 2) Currently enrolled in a closed-label interventional trial and actively receiving an investigational product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Time to identification of CREP as causative organism of the infection 2) Time from diagnosis of the current infection and start of antibiotic treatment 3) 28-day mortality for HAP/VAP or BSI and/or clinical (and/or microbiological) success based on the syndrome of infection for other severe infections, likely but not exclusively, cUTI/AP, ABSSSI, and cIAI due to CREPTimepoint: at 28th day from date of infection. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Clinical cure assessed at Day 7 (cUTI only), Day 14, Day 28 and end of treatment (EOT) 2) Microbiological eradication Day 7 (cUTI only), Day 14, Day 28 and EOT, if available 3) Microbiological success rates as primary endpoint usually applies to cUTI/AP only. For other infections, eg, HAP/VAP and bacteremia, the primary endpoint is mortality, hence clinical outcome. In these cases, the microbiological eradication rates will be set as secondary endpoints 4) Demographic and underlying disease risk factors including nosocomial factors Antibiotic treatment: agent and regimen, duration, empiric vs targeted 5) Hospital course and resource utilization duration of ICU stay, mechanical ventilation, hospital stay, time to discharge, readmission rates [for the treatment of the index carbapenem-resistant Enterobacterales/carbapenem-resistant P. aeruginosa infection], and cost of antibiotic treatment)Timepoint: 7 (cUTI only), Day 14, Day 28 and end of treatment (EOT) | — |
Countries
India, South Africa
Contacts
Public ContactRaji Devarajan
Kasturba Medical College, Manipal
Outcome results
None listed