Clinical trial will examine early transition from IV to oral antibiotics

Researchers at Johns Hopkins University have received $10 million to conduct a clinical trial that will investigate whether early transition to oral antibiotic therapy from intravenous (IV) administration improves outcomes in patients with gram-negative bloodstream infections.

The funding from the Patient-Centered Outcomes Research Institute will support a randomized controlled trial that will involve roughly 1,200 patients with bloodstream infections at eight US hospitals. The patients will be randomly assigned to two groups—one that receives IV antibiotics for the entire duration of therapy and one that starts on IV therapy, followed by an early transition to oral antibiotics.

Patients with bloodstream infections caused by gram-negative bacteria, such as Escherichia coli, have been traditionally treated with IV antibiotics. If patients are discharged home or to a skilled nursing facility, a vascular catheter is required to continue the treatment.

"However, because vascular catheters used to place IV lines can pose a risk of a secondary infection and other complications, and because IV therapy imposes limitations on patient mobility and quality of life, we want to see if oral antibiotic treatment—pills—given at an early stage in the process could achieve outcomes on par with those of IV antibiotics," co-principal investigator Pranita Tamma, MD, MHS, who directs the Pediatric Antimicrobial Stewardship Program at Johns Hopkins Children's Center, said in a university press release.

Tamma and her colleagues say they will use a novel analytical approach to determine efficacy and safety.

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