Cefepime-Taniborbactam Bests Meropenem in Complicated UTI Trial - Monthly Prescribing Reference

Positive results were announced from a phase 3 study evaluating cefepime-taniborbactam for the treatment of adults with complicated urinary tract infections (cUTI), including acute pyelonephritis.

The investigational drug is a combination of cefepime, a cephalosporin antibiotic, and taniborbactam, a novel beta-lactamase inhibitor. The Company believes that the combination may provide another therapeutic option for difficult-to-treat drug resistant gram-negative bacteria, such as carbapenem-resistant Enterobacterales and carbapenem-resistant Pseudomonas aeruginosa.

The global, randomized, double-blind, active-controlled CERTAIN-1 study (ClinicalTrials.gov Identifier: NCT03840148) compared the efficacy and safety of cefepime-taniborbactam to meropenem in 661 adults with cUTI, including acute pyelonephritis. Patients were randomly assigned 2:1 to receive cefepime-taniborbactam 2.5mg intravenously (IV) every 8 hours or meropenem 1g IV every 8 hours for 7 days (up to 14 days for patients with bacteremia). 

The primary endpoint was the composite of microbiological eradication and symptomatic clinical success at the test of cure (TOC) visit (days 19-23) in the microbiological intent-to-treat (microITT) population.

Results showed that treatment with cefepime-taniborbactam met the primary endpoint achieving statistical noninferiority to meropenem at the TOC visit in the microITT population. Composite microbiologic and clinical success occurred in 70% of patients treated with cefepime-taniborbactam compared with 58% of patients treated with meropenem (treatment difference 11.9%; 95% CI, 2.4-21.6). Moreover, cefepime-taniborbactam demonstrated statistical superiority to meropenem for the composite endpoint at TOC, which was sustained at the Late-Follow-Up visit (days 28-35).

Treatment-emergent adverse events (TEAEs) occurred in 35.5% of patients treated with cefepime-taniborbactam and 29% of patients treated with meropenem. Serious TEAEs occurred in 2% of patients treated with cefepime-taniborbactam and 1.8% of patients treated with meropenem.

Complete study results will be presented at an upcoming scientific meeting. The Company plans to submit a New Drug Application to the Food and Drug Administration (FDA) later this year.

"These data demonstrate that cefepime-taniborbactam may represent a significant improvement over the standard of care and could support global health efforts to combat antibiotic-resistant infections," said Christopher J. Burns, PhD, President and CEO of Venatorx. "Cefepime-taniborbactam, if approved by the FDA, may offer a new treatment option for patients with infections caused by highly resistant bacteria, even those resistant to widely used carbapenem antibiotics." 

Reference

Venatorx Pharmaceuticals announces positive results for phase 3 clinical trial (CERTAIN-1) of cefepime-taniborbactam for treatment of cUTI. News release. Venatorx Pharmaceuticals. Accessed March 10, 2022.https://www.businesswire.com/news/home/20220310005341/en/Venatorx-Pharmaceuticals-Announces-Positive-Results-for-Phase-3-Clinical-Trial-CERTAIN-1-of-Cefepime-Taniborbactam-for-Treatment-of-cUTI

Topics:

Bacterial Infections Urinary Tract Infection Urologic Disorders

Adblock test (Why?)

Comments

Post a Comment

Popular posts from this blog

Rashes that look like scabies: Causes, symptoms, and treatment - Medical News Today

Image
Scabies is a skin condition that occurs as the result of a mite known as Sarcoptes scabiei. The rash that results from scabies may appear similar to other skin conditions, such as psoriasis, eczema, or contact dermatitis. In this article, we look at what a scabies rash looks like. We also look at other rashes that are similar in appearance and their treatment options. Scabies is a common condition that occurs as the result of an infestation of a microscopic skin mite called Sarcoptes scabiei. The mites burrow under the skin, causing intense itching and a rash. The Centers for Disease Control and Prevention (CDC) describes the rash as pimple-like. On darker skin, the rash may be more difficult to see, but a person should be able to feel it. According to DermNet, a scabies rash is varied in appearance, and may appear as: pimple-like on the limbs and trunk widespread or coin-shaped small blisters scales lesions in the armpits, groin, navel, areolas, scrotum, buttocks, and along the penil
Read more

Urinary Tract Infection (UTI): Causes, Symptoms & Treatment - Cleveland Clinic

Image
Can I prevent a urinary tract infection? The following lifestyle changes can help prevent urinary tract infections: Practice good hygiene Practicing good hygiene is one of the best ways to help prevent UTIs. This is especially important if you have a vagina because your urethra is much shorter, and it's easier for E. coli to move from your rectum back into your body. Always wipe from front to back after a bowel movement (pooping) to avoid this. During your menstrual cycle, it's also a good idea to regularly change your period products, including pads and tampons. You should also avoid using any deodorants on your vagina. Drink plenty of fluids Drinking extra fluids — especially water — each day can help flush out bacteria from your urinary tract. Healthcare providers recommend drinking six to eight glasses of water daily. Change your peeing habits Peeing can play a big role in getting rid of bacteria from your body. Your pee is a waste product, and each time you empty your bla
Read more

Symtuza: Uses, side effects, alternatives, and more - Medical News Today

Image
The Food and Drug Administration (FDA) approves prescription drugs such as Symtuza to treat certain conditions. Symtuza is FDA-approved to treat HIV-1 in adults and children who weigh at least 40 kilograms (kg), which is about 88 pounds (lb). It's approved for people who: have just been diagnosed with HIV and haven't started treatment yet, OR are changing from another HIV treatment and: have been on a stable antiretroviral regimen for at least 6 months (this means you haven't had any changes to your HIV drugs for at least 6 months) have a viral load (the amount of HIV in your blood) that's less than 50 copies per milliliter (mL) have HIV that doesn't have mutations (changes) that could make it resistant (less likely to respond) to darunavir or tenofovir (two of the active drugs in Symtuza) HIV explained HIV stands for human immunodeficiency virus. There are two forms of this virus, HIV-1 and HIV-2. HIV-1 is the most common form. HIV is transmitted through body fluid
Read more