Procalcitonin-Guided Early Stop of Antibiotics Prevents Gut Inflammation and Preserves Gut Microbiome: Data from the PROGRESS Controlled Trial
Abstract
The PROGRESS randomized trial (ClinicalTrials.gov NCT03333304) showed that early stop of antibiotics guided by procalcitonin (PCT) decreased the incidence of infections by multidrug resistant organisms and/or Clostridioides difficile and was associated with survival benefit. We investigated if benefit is associated with microbiome dysbiosis. Patients with sepsis due to lung infection, acute pyelonephritis or primary bacteremia were randomized to standard-of-care (SoC) duration of antibiotics or early stop using PCT. Faecal samples were collected before, 7 and 28 days after randomization and analyzed by 16S rRNA Nanopore sequencing. Calprotectin was measured by an enzyme immunoassay. Median (Q1-Q3) antimicrobial duration was 5 days in PCT (5-7.5) and 11 days (8-15) in SoC arm, respectively (p < 0.001). Faecal calprotectin did not differ at baseline. By day 7, it was significantly increased in SoC (p=0.002) but it was unchanged in the PCT arm. Microbiome alpha- and beta-diversity were similar at baseline in PCT (n=81) and SoC (n=76) treated patients. Shannon's index was significantly decreased in SoC by day 7 from baseline (median [Q1-Q3], 2.88 [2.37-3.39] at day 1 vs 2.24 [1.52-3.08] at day 7; pt-test=0.0013); this was not the case for the PCT arm (median [Q1-Q3], 2.73 [2.26-3.4] at day 1 vs 2.43 [1.81-3.21] at day 7; pt-test=0.037, Bonferroni corrected alpha = 0.0125). Relative abundances of Actinomycetota and Pseudomonadota were decreased in PCT arm by day 7 and relative…
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: 81 participants or records.
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