LB-5. DAV132 Protects Intestinal Microbiota of Patients Treated with Quinolones, a European Phase II Randomized Controlled Trial (SHIELD)
Abstract
Abstract Background Antibiotics elicit intestinal dysbiosis with short and long-term deleterious effects. A colon-targeted adsorbent, DAV132, prevents dysbiosis in healthy humans and may protect antibiotic-treated patients. Methods Hospitalized patients receiving oral/iv fluoroquinolones (FQ) for the treatment of or prophylaxis of febrile neutropenia were randomized to receive DAV132 (7.5g tid orally), or not, during FQ receipt and followed up 51d. Plasma FQ levels were assessed at D4 (LC-MS/MS). Feces were collected during and up to 30d after FQ receipt for assessment of free fecal FQ levels (LC-MS/MS), gut microbiome α/β diversity (16S rRNA), resistance to colonization by C. difficile (Cd; ex-vivo proliferation). Relatedness of adverse events (AEs) to drugs was adjudicated by blinded independent experts. Results 243 patients from 23 sites, median age 71y, ≥1 chronic comorbidity 95%, received levofloxacin (43%), ciprofloxacin (40%) or moxifloxacin (18%) for (79% iv). During receipt, fecal FQ levels were lowered by >97% with DAV132 vs. No DAV132 (p< 0.0001), whilst plasma levels did not change significantly. Microbiome diversity was significantly protected with DAV132 using all metrics, e.g. the change from D1 of Shannon index at End-of-FQ (difference of means at End-of-FQ 0.42, 95% CI: 0.085; 0.752). The proportions of patients with DAV132- and/or FQ-related AEs (primary endpoint) did not differ significantly (14.8 vs. 10.8%, difference of proportions: 3.9%; 95% CI: -4.7;…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 243 participants or records.
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