Evidence map›Paper›PMID 28760801›Full record

Trial reportBMJ open2017

Polyethylene glycol intestinal lavage in addition to usual antibiotic treatment for severe

Greig McCreery, Philip M Jones, Biniam Kidane, Vanessa DeMelo, Tina Mele, ERASE C. difficile (Early Rescue from Acute SEvere Clostridium difficile) Trials Group

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ open, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02466698 (A Feasibility Randomized Trial of Intestinal Lavage for the Treatment of Severe C. Difficile Infections), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.6field-weighted citation impact, top 32% of its field
1 · What the graph read from it

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.

2 · The registry

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.

NCT02466698 phase2 / phase3unknown statusnot on this map

A Feasibility Randomized Trial of Intestinal Lavage for the Treatment of Severe C. Difficile Infections

TypeinterventionalSponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sRan2016 to 2019Enrolled20ConditionsClostridium DifficileArmsIntestinal Lavage, Vancomycin, PEG, Metronidazole
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Article
  3. Colonic lavage in treatment of refractoryJournal of surgical case reports · 2020
    Article
  4. Management ofTherapeutic advances in gastroenterology · 2019
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

Greig McCreeryDepartments of Surgery and Critical Care Medicine, University of Western Ontario, London, Ontario, Canada.
Philip M JonesDepartments of Surgery and Critical Care Medicine, University of Western Ontario, London, Ontario, Canada.
Biniam KidaneUniversity of Manitoba, Winnipeg, Manitoba, Canada.
Vanessa DeMeloDepartments of Surgery and Critical Care Medicine, University of Western Ontario, London, Ontario, Canada.
Tina MeleDepartments of Surgery and Critical Care Medicine, University of Western Ontario, London, Ontario, Canada.ORCID http://orcid.org/0000-0002-6617-9790
ERASE C. difficile (Early Rescue from Acute SEvere Clostridium difficile) Trials Group
Western University · CAUniversity of Manitoba · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionMETHODS AND ANALYSIS: We will conduct a 1-year, single-centre, pilot randomised controlled trial to study this new treatment strategy for patients with severe CDI and additional risk factors for fulminant or complicated infection. After informed consent, patients with severe-complicated CDI without immediate indication for surgery will be randomised to either usual antibiotic treatment or usual antibiotic treatment with the addition of 8 L of PEG lavage via nasojejunal tube. This pilot trial will evaluate our eligibility and enrolment rate, protocol compliance and adverse event rates and provide further data to inform a more robust sample size calculation and protocol modifications for a definitive multicentre trial design. Based on historical data, we anticipate enrolling approximately 24 patients during the 1-year pilot study period.As a pilot study, data will be reported in aggregate. Between-group differences will be assessed in a blinded fashion for evidence of harm, and to further refine our sample size calculation. ETHICS AND DISSEMINATION: This study protocol has been reviewed and approved by our local institutional review board. Results of the pilot trial and subsequent main trial will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT02466698; Pre-results.

Indexed as

Clostridioides difficileAdultAnti-Bacterial AgentsClostridium InfectionsFemaleHumansMaleMiddle AgedPilot ProjectsPolyethylene GlycolsTherapeutic IrrigationVancomycinAnti-Bacterial AgentsPolyethylene GlycolsVancomycinAdult intensive and critical careClostridium difficileGastrointestinal infections

Identifiers

PMID28760801
PMCPMC5642754
OpenAlexW2740838585

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.