Treatment for Resolving C. Diff Infection ‘So Effective’ that Trial Discontinued
In a clinical trial, researchers found that, after a course of vancomycin, faecal microbiota transplantation (FMT) resolved Clostridioides difficile infections significantly more effectively than standard care alone. The treatment was so effective that further participant recruitment was halted. The findings were published in The Lancet Gastroenterology and Hepatology.
The results of the randomised, double-blind, placebo-controlled trial are extremely encouraging, said Simon Mark Dahl Baunwall, a PhD student at the Department of Clinical Medicine and a doctor at Aarhus University Hospital.
“Our new study shows that we can effectively cure the infection through the early use of faecal microbiota transplantation (FMT) after completing the standard treatment, to prevent relapses,” he said.
Few treatment options are available for the urgent threat of C. diff infections. Microbiota restoration with faecal microbiota transplantation is an effective treatment option for patients with multiple recurring episodes of C. diff. The researchers compared the efficacy and safety of faecal microbiota transplantation compared with placebo after vancomycin for first or second C. diff infection.
At a Danish hospital, 42 eligible patients with first or second C. difficile infection were randomly assigned to either faecal microbiota transplantation or placebo administered on day 1 and between day 3 and 7, after they had received 125mg oral vancomycin four times daily for 10 days. The primary endpoint was resolution of C difficile-associated diarrhoea (CDAD) eight weeks after treatment, with patients followed for eight weeks or until recurrence.
Due to the efficacy The primary outcome and safety outcomes were analysed in the intention-to-treat population, which included all randomly assigned patients.
Findings
The trial was stopped after the interim analysis done on April 7, 2022 for ethical reasons because the placebo group had a much lower rate of resolution at week 8 (33%) than the treatment group (90%). The absolute risk reduction was 57%.
“In rare cases, it can happen that you discover that the treatment you are investigating is so effective that it is ethically indefensible to continue,” said Baunwall.
“Our study is one example, in that the new FMT treatment is so much better than the standard treatment with antibiotics that it would be unethical to continue, because the patients in the control group would risk not receiving the FMT treatment.”
Overall, 204 adverse events occurred, with one or more adverse events being reported in 20 of 21 patients in the FMT group and all 21 patients in the placebo group, with the most common being diarrhoea and abdominal pain.
Interpretation
The study authors concluded that FMT in patients with first or second C. diff infection, is highly effective and superior to the standard of care vancomycin alone in achieving sustained resolution from C. diff.
Source: Aarhus University
