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Adverse event rates did not significantly differ between patients treated with both DAV132 and Fluoroquinolone and patients treated only with fluoroquinolone.
A new treatment could help restore the gut microbiota and reduce the risk of clostridium difficile infections (CDI) in hospitalized patients.
A team, led by Maria J. G. T. Vehreschild. Department of Internal Medicine, Infectious Diseases, University Hospital Frankfurt, Goethe University Frankfurt, assessed the safety and efficacy of DAV132.
DAV132 is a colon-targeted adsorbent that has shown promise preventing antibiotic-induced effects on the microbiota in healthy individuals.
In the open-label, randomized, multicenter trial, the investigators compared DAV132 7.5 g, 3 times a day, orally, with No-DAV132 in patients hospitalized requiring 5-21 day treatment with fluoroquinolone at risk for C difficile infections. Overall, there were 243 patients with a median age of 71 years. In addition, 96% of the patient population had at least 1 chronic comorbidity.A total of 120 patients were in the No-DAV132 group, compared to 123 patients in the DAV132 cohort.
Both fluoroquinolone and DAV132 were started simultaneously, with DAV132 administered 48 hours more. Each patient was followed up with for 51 days.
The investigators sought primary endpoints of the rate of adverse events independently adjudicated as related to either treatment.
The team assessed plasma and fecal fluoroquinolone concentrations, intestinal microbiota diversity, intestinal colonization with C difficile, MDR bacteria and yeasts, and ex vivo resistance to C difficile fecal colonization.
The investigators found there was not much difference between the 2 treatments on treatment-related adverse events.
There was a total of 18 (14.8%) in the DAV132 group, compared to 13 (10.8%) in the fluoroquinolone group (difference 3.9%; 95% CI: −4.7 to 12.6). At day 4, the fluoroquinolone plasma levels were also unaffected.
On the other hand, DAV132 results in a greater than 98% reduction in fecal fluoroquinolone levels (Day 4 to end of treatment; P < 0.001), less impaired microbiota diversity (Shannon index; P = 0.003), increased ex vivo resistance to C. difficile colonization (P = 0.0003), and less frequent FQ-induced VRE acquisition (P = 0.01).
“In FQ-treated hospitalized patients, DAV132 was well tolerated, and FQ plasma concentrations unaffected,” the authors wrote. “DAV132 preserved intestinal microbiota diversity and C. difficile colonization resistance.”
Last year, investigators found DAV132 could prevent antibiotic disruption of intestinal flora against C difficile in patients with hematologic malignancies.
In results from a phase 2 trial described by the manufacturer, 7.5gm of DAV132 administered 3 times daily to elderly patients receiving oral or intravenous fluoroquinolone antibiotics demonstrated protection against antibiotic-induced disruption of intestinal microbiota.
According to the manufacturer's summary of the trial results, the adsorbent product significantly reduced free fecal concentrations of fluoroquinolones without affecting their plasma levels, and therefore without affecting their efficacy in treating the patients' infections.
The study, “An open randomized multicenter Phase 2 trial to assess the safety of DAV132 and its efficacy to protect gut microbiota diversity in hospitalized patients treated with fluoroquinolones,” was published online in the Journal of Antimicrobial Chemotherapy.