Risk factors for infections with drug-resistant Pseudomonas aeruginosa
Research type
Research Study
Full title
Study of risk factors for infections with drug-resistant Pseudomonas aeruginosa
IRAS ID
240883
Contact name
Matthew Dryden
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Duration of Study in the UK
1 years, 7 months, 31 days
Research summary
Pseudomonas aeruginosa (PsA) is a bacterium which can be found in many healthcare settings and has the potential to cause infections in adults and children, such as pneumonias, urinary tract infections, and bloodstream infections. What is particularly worrisome about PsA is that this bacterium is developing resistance to current antibiotics.
Treating patients with appropriate antimicrobials is critical to ensure positive patient outcomes. However, the selection of the most appropriate treatment for complicated infections like the ones caused by PsA is not straightforward. Doctors often lack timely information on the bacterium causing the infection and its antimicrobial sensitivity due to the time required to complete tests and obtain the test results. This study aims to develop a predictive tool with which doctors will be able to make reasoned assumptions about antimicrobial sensitivity in the absence of test results, in order to more quickly select the right treatment for patients and improve their outcomes. This study will also analyse the economic implications of PsA infections to the hospitals treating these infections.
This non-interventional, observational study will be conducted in two phases; both will employ a chart review approach. The study will be conducted in five European countries: France, Germany, Italy, Spain, and the United Kingdom (UK). The source population for this study will be hospitalized adult patients (≥18 years old). The study will last Approximately 20 months.
Participating doctors (one doctor per country) will be asked to retrospectively examine their microbiology/infection control records for patient eligibility, starting from the time of site initiation and moving backwards for 24 months until the required numbers of patients for both study phases have been reached per site.
Study-related data will be collected retrospectively from the medical records. Participating patients will not undergo any study-related procedures.
Lay summary of results
There were 242 patients (121 Controls and 121 Cases). Most patients were male (73.6% in Controls and 64.5% in Cases) and the mean (SD) age in Controls and Cases was 70.0 (13.8) and 62.0 (15.3) years. The use of invasive procedures including cardiac catheterisation (OR=4.33, p=0.0376), use of nasogastric feeding tube (OR=3.18, p=0.0084), and prior PSA infection (OR: 3.82, p=0.0301) were associated with drug-resistant PSA infection. Among Cases, 53 (43.8%) patients received inappropriate antimicrobial therapy (IAT). Patients with IAT stayed longer at hospital (for mean [SD] 34.0 [59.0] days), than patients with appropriate antimicrobial therapy (29.0 [30.7] days).
Conclusion:- Cardiac catheterisation, use of nasogastric feeding tube, and prior PSA infections were identified as independent risk factors for drug-resistant PSA infection. Which can help to identify patients requiring aggressive antibiotic therapy.
REC name
West of Scotland REC 1
REC reference
19/WS/0045
Date of REC Opinion
1 May 2019
REC opinion
Further Information Favourable Opinion