Vaccine candidate for recurrent MDR UTIs fast-tracked by FDA
Sequoia Sciences announced yesterday that it has received fast-track designation from the US Food and Drug Administration (FDA) for its investigational vaccine designed to treat recurrent urinary tract infections (UTIs) caused by multidrug-resistant (MDR) bacteria. Fast-track designation expedites the development and review of the vaccine through the US regulatory process.
Sequoia's vaccine is designed to produce an immune response preventing bacteria from colonizing the urinary tract, and it recently completed its first clinical trial in women. Among the 67 women enrolled in the study, 30 of whom had a 2-year history of recurrent UTI, the vaccine was well-tolerated and generated a strong immune response, the company said in a news release.
Based on these results, Sequoia has begun additional studies, including evaluating the vaccine in patients requiring antibiotics of last resort. In granting fast-track status, the FDA acknowledges that recurrent UTI caused by MDR bacteria is a serious condition for which there is an unmet medical need, Sequoia said.
"If approved, the vaccine could change the standard of care for recurrent UTI," said Gary Eldridge, president and CEO, Sequoia Sciences. "Since UTI[s] are a primary source of sepsis, decreasing recurrent UTI may ultimately drive down rates of hospitalization, sepsis, and associated in-hospital mortality."
Currently, patients who have recurrent UTI frequently take daily antibiotics for 1 to 4 months or even longer, which can lead to drug resistance, according to the release. Each year, about 3 million patients in the United States and 10 million in North America, Europe, and Japan experience recurrent UTI, about half of which is caused by antibiotic-resistant bacteria.
Jul 26 Sequoia Sciences news release
Group develops roadmap for MDR gonorrhea
Yesterday an international group of experts published a research and development roadmap for the discovery of new drugs for MDR gonorrhea, part of efforts by the Global Antibiotic Research and Development Partnership (GARDP), which was launched by the World Health Organization and Drugs for Neglected Disease initiative last year.
The roadmap, published as a commentary in PLoS Medicine, lays out a 7-year plan for health officials and includes four main components and a target product profile (TPP) for new medicines.
The number of gonorrhea cases has risen in many areas across the globe, an increasing proportion of which are MDR. The choice of treatment options for gonorrhea is very limited, and resistance has even been reported to extended-spectrum cephalosporins, the mainstay of current first-line therapy. Also, only three new chemical entities are in different stages of clinical development for treatment of gonorrhea, the experts report.
The plan's key components are: (1) accelerate development of a new molecule to treat the disease, (2) evaluate the potential of existing antibiotics and combinations, (3) explore co-packaging and development of fixed-dose combinations, and (4) support the development of simplified treatment guidelines and foster conservation.
The TPP includes "ideal" and "acceptable" criteria for such factors as indication, tolerability, cost, stability, and dosing schedule for new gonorrhea drugs.
The authors write, "Over the next 7 years, this research and development proposal includes the following: exploring the introduction of a new clinical entity against gonorrhea; the identification of existing, suitable partner drugs; the recovery of previously abandoned, out-of-favor, and withdrawn antibiotics; and the development of simplified treatment guidelines for the empiric management of sexually transmitted infections."
Jul 26 PLoS Med commentary
GARDP TPP
Analysis finds follow-up blood cultures unnecessary for bacteremia
An analysis of 383 bacteremia cases by University of Texas scientists has determined that follow-up blood cultures for gram-negative bacteremia are unnecessary and contribute to increased healthcare costs, longer hospital stays, unnecessary consultations, and inappropriate use of antibiotics.
The researchers, reporting in Clinical Infectious Diseases yesterday, analyzed data on 383 bacteremia patients who had at least one follow-up blood culture (FUBC). They gleaned information on presumed source of disease, antibiotic status at the time of FUBC, antibiotic susceptibility, presence of fever, comorbidities, need for intensive care, and mortality.
They found that antibiotic use did not affect the rate of positivity of FUBC, unless bacteria were not sensitive to the empiric antibiotic. Fever on the day of FUBC was associated with higher rates of positive FUBC for gram-positive cocci but not gram-negative bacilli (GNB). Mortality and care in the intensive care unit were also not associated with a positive FUBC.
The authors conclude, "FUBC added little value in the management of GNB bacteremia. Unrestrained use of blood cultures has serious implications for patients, including increased healthcare costs, longer hospital stays, unnecessary consultations, and inappropriate use of antibiotics."
Jul 26 Clin Infect Dis abstract
Scottish data platform helps inform Infection control, stewardship
A new paper in the Journal of Antimicrobial Chemotherapy describes efforts in Scotland to use patient data to better understand the epidemiology of infectious disease and inform and evaluate antimicrobial stewardship programs.
The objective of the Infection Intelligence Platform (IIP), which is led by the Scottish Antimicrobial Prescribing Group (SAPG) and supported by National Health Services Scotland (NHS), is to create a national infection informatics resource for infection control and stewardship clinicians. The program is focused on three objectives: Developing a technical platform to link the various NHS patient datasets to enhance surveillance capability; establishing a governance process that ensures the data is secure and accessible; and using the data to generate new evidence to guide clinical practice.
The authors report that in the build-out and test phase of the IIP, they have improved data security, created "simplified views" of the complex datasets, and embedded statistical programs to enhance capability. These developments have enabled researchers to conduct studies using the datasets. These studies have measured the intended and unintended effects of antimicrobial stewardship and infection management intervention and examined infection risk factors and clinical outcomes.
Findings from the studies have been disseminated to clinicians through the IIP website, regular newsletters, and presentations at international meetings, and the authors say the evidence is already shaping clinical practice.
"We are part way along our IIP journey and have begun to increase our responsiveness to address important clinical questions that could be answered through a data linkage approach," the authors write. "We hope our shared experience will inform and encourage others to embark upon this journey and catalyse opportunities for global collaboration."
Jul 10 J Antimicrob Chemother paper