Innovative UTI Medication Needed for Children

RECCE 327 fast dosing UTI medication advances in Phase 2 clinical research
by Thao Tang Van
Austin (Precision Vaccinations News)

A new analysis of emergency department (ED) visits for pediatric urinary tract infections (UTIs sheds light on antibiotic prescribing practices, as reported today in the journal Pediatrics.

Published on June 11, 2024, the Research Brief assessed changes in antibiotic prescribing at ED visits for pediatric UTIs from 2011 to 2020 using nationally representative data from the National Hospital Ambulatory Medical Care Survey. A total of 1,083 UTI visits by non-pregnant patients ages 18 and younger were included in the analysis.

Over the study period, trimethoprim-sulfamethoxazole prescriptions declined from 20.6% to 9.9% of visits, while the use of cephalosporins increased from 15.2% to 32.6% of visits, and the use of third-generation cephalosporins (e3GC) remained unchanged.

"Although e3GC use had increased previously, their prescription rate did not significantly change, perhaps reflecting appropriate use in areas with higher resistance," the authors wrote.

"Given their association with the development of resistance, ongoing monitoring and quality improvement will be important."

According to the U.S. CDC, UTIs are common infections in children caused by bacteria, often from the skin or rectum, entering the urethra and infecting the urinary tract. In high-income countries, UTIs affect up to 2.8% of children annually, with recurrence rates ranging from 8% to 30%.

Specifically, recurrent urinary tract infections (rUTIs) pose a significant health concern, particularly among young women. It is estimated that 11.3% of females develop at least one episode of UTI within the first 16 years of life.

A separate announcement today indicates that the next-generation RECCE® 327 intravenous and topical therapy is successfully advancing in phase 2 research. RECCE 327 is being developed to treat severe and potentially life-thretions caused by Gram-positive and Gram-negative bacteria.

Australia-based Recce Pharmaceuticals Limited reports it has completed the dosing of its latest cohort in its Phase I/II UTI/Urosepsis clinical trial, evaluating RECCE® 327 at fast infusion rates.

An Independent Safety Committee will review and evaluate the data, with preliminary results expected in mid-2024.

Data from this trial is expected to pave the way for a Phase II UTI/Urosepsis efficacy trial, potentially establishing R327 as a frontline treatment.

According to the Company, administering antibiotics through rapid intravenous infusions has proven to be a safe and effective method that significantly impacts patient treatment, reduces wait times, and alleviates nursing workloads worldwide.

Recce's Chief Executive Officer James Graham commented in a press release on June 11, 2024, "We have reached a new milestone in this trial by administering a 4,000mg dose over a fast 20-minute infusion to all subjects, the highest dosage achieved so far in this clinical trial."

"This is a significant step forward in bringing us closer to establishing R327 as a leading treatment for those suffering from UTI/Urosepsis."

The U.S. FDA has awarded RECCE® 327 Qualified Infectious Disease Product designation, labeling it for Fast Track Designation.

From a prevention perspective, a restricted-access oral spray rUTI vaccine (Uromune™ MV140) is available in other countries in 2024, but not in the U.S.

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