A feasibility cum observational study in adults and children hospitalized for serious bacterial infections caused by antibiotic resistant bacteria

Not Applicable

• Conditions: Health Condition 1: B968- Other specified bacterial agents as the cause of diseases classified elsewhere

• Registration Number: CTRI/2022/04/042036
• Lead Sponsor: Global Antibiotic Research and Development Partnership GARDP

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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 patientââ?¬•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

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified