Tag Archives: Clostridium difficile treatment clinical study

University of Australia Researchers Find Ramizol as a Potential to Be Standard of Care For Treating C.difficile Infection

Researchers have now developed a new antibiotic that is heralded as a breakthrough against a lethal drug-resistant hospital superbug.

Antibiotic Ramizol was found safe and effective in addressing the Clostridium difficile (C. difficile) infection which is becoming resistant to traditional antibiotics caused by drug-resistant bacteria.

C.difficile is considered one of the most common infections acquired during hospital visits and the most likely cause of diarrhoea for patients and staff in hospitals.

It causes a deadly infection in the large intestine and is most common in people who need to take antibiotics for a long period of time.

“Cases of C.difficile disease are rising and the strains are becoming more lethal. If there is an imbalance in your intestines it can begin to grow and release toxins that attack the lining of the intestines which leads to symptoms,” said Ramiz Boulos, adjunct research associate at Flinders University in Australia.

For the study, the team gave 48 rats a high dose of a new class of antibiotic for 14 days to assess its safety.

The findings, published in the journal Scientific Reports, showed that when doses of the new antibiotic were given to rats infected with the bacteria, a significant proportion of them survived the infection.

“Our research indicates Ramizol is an extremely well-tolerated antibiotic in rats, with good microbiology and antioxidant properties. It also has high chemical stability and is scalable because of the low cost of manufacturing, which could make it a viable treatment option,” Boulos said.

In addition, a very high dose on rats showed no mortalities or side effects.
There were also no changes in mean body weight, weight gain, food consumption or food efficiency for male and female rats attributable to Ramizol.

“We believe Ramizol has the potential to be the standard of care for treating C.difficile infection and has the potential to be a blockbuster drug,” Boulos noted.

 

Source:  https://www.socialnews.xyz/2019/01/19/novel-antibiotic-to-combat-drug-resistant-hospital-superbug/

Surotomycin Failed To Show Benefit Over Vancomycin In a Pivotal Phase 3 Trial To Treat C. difficile Infections

A similar proportion of patients with Clostridium difficile infection showed clinical response at the end of treatment with surotomycin vs. vancomycin in a pivotal phase 3 trial.

However, surotomycin did not demonstrate superiority for key secondary endpoints including sustained clinical response and clinical response over time, and therefore failed to show benefit over vancomycin.

 

As published :  https://www.healio.com/gastroenterology/infection/news/online/%7B3531418d-42aa-4092-a9f2-55ba2ce6dcda%7D/surotomycin-meets-non-inferiority-endpoint-fails-to-show-benefit-over-vancomycin-in-c-difficile

This follows previously reported results of a parallel phase 3 trial in which surotomycin failed to meet non-inferiority criteria relative to vancomycin for primary and key secondary endpoints.

“Surotomycin has a narrow spectrum of activity, demonstrating low resistance rates and rapid activity against C. difficile with similar dose- and time-dependent pharmacodynamics to vancomycin in resolving CDI in a hamster model,” Sahil Khanna, MBBS, of the division of gastroenterology and hepatology at the Mayo Clinic in Rochester, Minn., told Healio Gastroenterology and Liver Disease.

In this second phase 3 trial, “surotomycin demonstrated non-inferiority to vancomycin for CDI clinical response at end of treatment. It was similar to vancomycin for sustained clinical cure.”

In this double-blind, international multicenter trial, Khanna and colleagues randomly assigned 285 patients with confirmed CDI to receive 250 mg oral surotomycin twice daily alternating with placebo twice daily, and 292 to receive 125 mg oral vancomycin four times daily for 10 days.

At the end of treatment, clinical response with surotomycin (83.4%) was non-inferior to vancomycin (82.1%), with a difference of 1.4% (95% CI, 4.9-7.6).

Through 30 to 40 days of follow-up, clinical response over time was not superior to surotomycin, nor was sustained clinical response (63.3% vs. 59%; difference, 4.3%; 95% CI, 3.6-12.2).

Both treatments were generally well tolerated, with typical treatment-emergent adverse events occurring in 52.4% of patients treated with surotomycin and 60.1% of those treated with vancomycin.

“Interestingly, in the hypervirulent strain of CDI, recurrence rate was lower for surotomycin vs. vancomycin,” Khanna said, though he and colleagues noted in the study manuscript that “this finding is nominal due to a lack of multiplicity control.”

Based on the results of these trials, the surotomycin development program has been discontinued, but “the non-inferiority of surotomycin to vancomycin observed in the current trial is in contrast with the parallel trial,” investigators wrote. – by Adam Leitenberger

Disclosures: This study was funded by Merck. Khanna reports he has served as an advisor to Summit Pharmaceuticals and serves as a consultant to Rebiotix and Assembly Biosciences. Please see the full study for a list of all other researchers’ relevant financial disclosures.

SOURECE:  https://www.healio.com/gastroenterology/infection/news/online/%7B3531418d-42aa-4092-a9f2-55ba2ce6dcda%7D/surotomycin-meets-non-inferiority-endpoint-fails-to-show-benefit-over-vancomycin-in-c-difficile

Fight C. diff. With A Non-Toxic Strain Of C. diff

In The News:

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Dale Gerding, M.D., a professor of medicine at Loyola University’s Stritch School of Medicine in Chicago says, “Antibiotics disrupt your normal microbiota and when they do that they enable you to be susceptible to C. diff.”

Even after treatment, C. diff comes back in 20 percent of patients.

O’Riordan had it six times in less than a year.

Dr. Gerding has patented a novel treatment to prevent recurrence by giving patients a non-toxic strain of C. diff.

“Instead of replacing the microbiota, which is what a fecal transplant does, all this does is replace the C. Diff,” explains Dr. Gerding

Stuart Johnson, M.D., an infectious disease physician and professor of medicine at Loyola University’s Stritch School of Medicine says, “You can think of it as a probiotic, we like to think of it as a bio-therapeutic.”

They believe a non-toxic strain of C. diff could be the answer to protecting hundreds of thousands of people against the fastest growing superbug.

“I don’t want to go through this again, ever. Ever! Anything even remotely like that,” says O’Riordan.

Dr. Gerding said the non-toxic strain of C. diff doesn’t have any serious side effects, and it stays in the body for up to five months, which is why it cut the recurrence rate to two percent in studies.

Dr. Gerding is currently looking for a company to develop the treatment. It would be given in pill or liquid form.

For article in its entirety please click on the link below:

http://www.wtvm.com/story/32162456/fighting-c-diff-with-c-diff