Trial reportThe Journal of antimicrobial chemotherapy2022
An open randomized multicentre Phase 2 trial to assess the safety of DAV132 and its efficacy to protect gut microbiota diversity in hospitalized patients treated with fluoroquinolones.
Trial report in The Journal of antimicrobial chemotherapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
24 citing papers in PubMed, 46 citations in OpenAlex.
- The DAV132 colon-targeted adsorbent does not interfere with plasma concentrations of antibiotics but prevents antibiotic-related dysbiosis: a randomized phase I trial in healthy volunteers.Nature communications · 2024Trial
- The Cost of the Cure: Antibiotic Exposure as a Risk Factor for Irritable Bowel Syndrome.Antibiotics (Basel, Switzerland) · 2026Review
- Antibiotic-induced gut microbiome dysbiosis: risks and strategies for mitigation.The EMBO journal · 2026Review
- The intestinal microbiota as a key modulator of acute graft-versus-host disease.Nature reviews. Cancer · 2026Review
- Influence of Gut Microbiota on Response to Immune Check Point Inhibitors in MASLD Patients With HCC: Unraveling the Connection.Cancer medicine · 2026Review
- Microbiome, GvHD, and immune reconstitution in allogeneic hematopoietic cell transplantation.Bone marrow transplantation · 2026Review
- The impact of different antimicrobial exposures on the gut microbiome in the ARMORD observational study.eLife · 2025Observational
- The gastrointestinal microbiome in critical illness: A Clinician's guide to mechanisms, emerging tools, and therapeutic questions.Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine · 2025Review
- The gut microbiome as a target in cancer immunotherapy: opportunities and challenges for drug development.Nature reviews. Drug discovery · 2025Review
- Article
- Unraveling the Role of the Microbiota in Cancer Immunotherapy: A New Frontier.Research (Washington, D.C.) · 2025Review
- The Parkinson's disease drug entacapone disrupts gut microbiome homoeostasis via iron sequestration.Nature microbiology · 2024Article
- Review
- Fecal Microbiota Transfer in Acute Graft-versus-Host Disease following Allogeneic Stem Cell Transplantation.Visceral medicine · 2024Review
- Review
- European Practice for CDI Treatment.Advances in experimental medicine and biology · 2024Article
- Antibiotic perturbations to the gut microbiome.Nature reviews. Microbiology · 2023Review
- The Parkinson's drug entacapone disrupts gut microbiome homeostasis via iron sequestration.bioRxiv : the preprint server for biology · 2023Article
- Towards modulating the gut microbiota to enhance the efficacy of immune-checkpoint inhibitors.Nature reviews. Clinical oncology · 2023Review
- Clostridioides difficile Infection in Children: Recent Updates on Epidemiology, Diagnosis, Therapy.Pediatrics · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 6 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDAV132 (colon-targeted adsorbent) has prevented antibiotic-induced effects on microbiota in healthy volunteers.
objectivesTo assess DAV132 safety and biological efficacy in patients. PATIENTS AND
methodsAn open-label, randomized [stratification: fluoroquinolone (FQ) indication] multicentre trial comparing DAV132 (7.5 g, 3 times a day, orally) with No-DAV132 in hospitalized patients requiring 5-21 day treatment with FQs and at risk of Clostridioides difficile infection (CDI). FQ and DAV132 were started simultaneously, DAV132 was administered for 48 h more, and patients were followed up for 51 days. The primary endpoint was the rate of adverse events (AEs) independently adjudicated as related to DAV132 and/or FQ. The planned sample size of 260 patients would provide a 95% CI of ±11.4%, assuming a 33% treatment-related AE rate. Plasma and faecal FQ concentrations, intestinal microbiota diversity, intestinal colonization with C. difficile, MDR bacteria and yeasts, and ex vivo resistance to C. difficile faecal colonization were assessed.
resultsTwo hundred and forty-three patients (median age 71 years; 96% with chronic comorbidity) were included (No-DAV132, n = 120; DAV132, n = 123). DAV132- and/or FQ-related AEs did not differ significantly: 18 (14.8%) versus 13 (10.8%) in DAV132 versus No-DAV132 patients (difference 3.9%; 95% CI: -4.7 to 12.6). Day 4 FQ plasma levels were unaffected. DAV132 was associated with a >98% reduction in faecal FQ 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).
conclusionsIn FQ-treated hospitalized patients, DAV132 was well tolerated, and FQ plasma concentrations unaffected. DAV132 preserved intestinal microbiota diversity and C. difficile colonization resistance.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.