image: PCORI has awarded $10 million to Johns Hopkins Medicine to see if early transition to oral antibiotic therapy from IV administration improves outcomes for patients with Gram-negative blood infections, such as Pathogenic Escherichia coli seen in the background.
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Credit: Graphic created by ME Newman, Johns Hopkins Medicine, using public domain images, including scanning electron micrograph of E. coli courtesy of the National Institute of Allergy and Infectious Diseases

To study how best to treat potentially dangerous infections commonly seen in people with underlying chronic conditions, two infectious disease experts from Johns Hopkins Medicine have been awarded research funding of $10 million over five years by Patient -Centered Outcomes Research Institute (PCORI).

PCORI is an independent, nonprofit organization authorized by Congress in 2010. According to the institute, its mission is to “fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make healthcare decisions more enlightened”.

The award will support a randomized controlled clinical trial at eight US hospitals involving a study population of approximately 1,200 patients with bloodstream infections caused by gram-negative bacteria, such as Escherichia coli.

Gram-negative bacteria are organisms that are not stained by the Gram stain method used to differentiate bacteria into two distinct groups: Gram-positive and Gram-negative.

“According to previous studies, approximately 1 in 5 patients with chronic diseases will develop gram-negative bacteremia in their lifetime,” said study co-principal investigator Sara Cosgrove, MD, director of the Department of Disease Management. antimicrobials from Johns Hopkins Hospital. Program and Professor of Medicine at Johns Hopkins University School of Medicine. “Urinary tract infections, intra-abdominal infections, pneumonia, diabetic foot infections, and vascular catheter infections can all lead to Gram-negative bacteremia.”

The co-principal investigator of the study is Pranita Tamma MD, MHS, Director of

Pediatric Antimicrobial Stewardship Program at Johns Hopkins Children’s Center and Associate Professor of Pediatrics at Johns Hopkins University School of Medicine.

“Traditionally, gram-negative bacteremias have been treated intravenously [IV] antibiotics for the duration of a patient’s treatment – ​​either in hospital or with placement of a vascular catheter to continue treatment at home or in a skilled nursing facility,” says Tamma. “However, because the vascular catheters used to place IV lines may pose a risk of secondary infection and other complications, and because IV therapy imposes limitations on patients’ mobility and quality of life, we want to see if oral antibiotic treatment – pills – given early in the process might achieve results comparable to IV antibiotics.

In their clinical trial, Cosgrove, Tamma and their colleagues will randomly assign patients to one of two groups: those who receive IV antibiotics for the duration of treatment and those who start with IV treatment followed by an early transition to oral antibiotics for the rest of the treatment. Classes.

The study, says Tamma, will be conducted in eight hospitals strategically selected because they meet the following criteria: a mix of urban, suburban and rural populations; geographic distribution across the United States; racially and ethnically diverse populations; and the infrastructure needed to participate in a large randomized controlled trial.

Investigators, Cosgrove says, will use a new analytical approach to determine efficacy and safety, using criteria developed by both patients and healthcare providers. “This will allow us to define the optimal treatment approach for patients with Gram-negative bloodstream infections,” she explains.

“Johns Hopkins Medicine has been at the forefront of research to improve the treatment of bacterial diseases and optimize patient outcomes, especially for those with chronic conditions,” says Amita Gupta, MD, MHS, Director of the Division of Infectious Diseases and Professor of Medicine at Johns Hopkins University School of Medicine. “With this tremendous award, we can work with our partner medical institutions across the country to make a very positive difference in how effectively we treat Gram-negative bacterial bloodstream infections.”

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