Evidence map›Paper›PMID 35387830›Full record

Trial reportBMJ open2022

Randomised, double-blind, placebo-controlled, phase 2, superiority trial to demonstrate the effectiveness of faecal microbiota transplantation for selective intestinal decolonisation of patients colonised by carbapenemase-producing

Elena Pérez-Nadales, Ángela Cano, Manuel Recio, María José Artacho, Julia Guzmán-Puche, Antonio Doblas, Elisa Vidal, Clara Natera, Luis Martínez-Martínez, Julian Torre-Cisneros and 1 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIRandomized Controlled TrialEquivalence Trial
In one paragraph

Trial report in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04760665 (Randomized, Superiority, Double Blind Controlled With Placebo, Clinical Trial, to Demonstrate the Effectiveness of Fecal Microbiota Transplantation for Selective Intestinal Decolonization of Patients Colonized by Klebsiella Pneumoniae Carbapenemase), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
0.8field-weighted citation impact, top 28% 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.

NCT04760665 phase2terminatednot on this map

Randomized, Superiority, Double Blind Controlled With Placebo, Clinical Trial, to Demonstrate the Effectiveness of Fecal Microbiota Transplantation for Selective Intestinal Decolonization of Patients Colonized by Klebsiella Pneumoniae Carbapenemase (KPC)-Producing

TypeinterventionalSponsorMaimónides Biomedical Research Institute of CórdobaRan2021 to 2023Enrolled2ConditionsCarbapenemase-producing Enterobacteriaceae InfectionArmsFecal microbiota transplantation, Placebo
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 10 citations in OpenAlex.

  1. Review
  2. Review
  3. Review
  4. Antimicrobial Resistance: The Answers.British journal of biomedical science · 2026
    Review
  5. Review
  6. Article
  7. Review
  8. The Relationship Between the Microbiome and Antimicrobial Resistance.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023
    Article
  9. 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

11 authors at 3 institutions in 2 countries.

Elena Pérez-NadalesInstituto Maimónides de Investigación Biomédica de Córdoba/Hospital Universitario Reina Sofía/Universidad de Córdoba (IMIBIC/HURS/UCO), Cordoba, Spain.
Ángela CanoInstituto Maimónides de Investigación Biomédica de Córdoba/Hospital Universitario Reina Sofía/Universidad de Córdoba (IMIBIC/HURS/UCO), Cordoba, Spain.
Manuel RecioInstituto Maimónides de Investigación Biomédica de Córdoba/Hospital Universitario Reina Sofía/Universidad de Córdoba (IMIBIC/HURS/UCO), Cordoba, Spain.
María José ArtachoUnidad de Gestión Clínica de Microbiología, Hospital Santa Ana, Motril, Granada, Spain.
Julia Guzmán-PucheInstituto Maimónides de Investigación Biomédica de Córdoba/Hospital Universitario Reina Sofía/Universidad de Córdoba (IMIBIC/HURS/UCO), Cordoba, Spain.
Antonio DoblasUnidad de Gestión Clínica de Enfermedades Infecciosas, Hospital Universitario Reina Sofía de Córdoba, Cordoba, Spain.
Elisa VidalInstituto Maimónides de Investigación Biomédica de Córdoba/Hospital Universitario Reina Sofía/Universidad de Córdoba (IMIBIC/HURS/UCO), Cordoba, Spain.
Clara NateraInstituto Maimónides de Investigación Biomédica de Córdoba/Hospital Universitario Reina Sofía/Universidad de Córdoba (IMIBIC/HURS/UCO), Cordoba, Spain.
Luis Martínez-MartínezInstituto Maimónides de Investigación Biomédica de Córdoba/Hospital Universitario Reina Sofía/Universidad de Córdoba (IMIBIC/HURS/UCO), Cordoba, Spain.
Julian Torre-CisnerosInstituto Maimónides de Investigación Biomédica de Córdoba/Hospital Universitario Reina Sofía/Universidad de Córdoba (IMIBIC/HURS/UCO), Cordoba, Spain julian.torre.sspa@juntadeandalucia.es.ORCID 0000-0003-1529-6302
Juan José CastónInstituto Maimónides de Investigación Biomédica de Córdoba/Hospital Universitario Reina Sofía/Universidad de Córdoba (IMIBIC/HURS/UCO), Cordoba, Spain.
Instituto de Salud Carlos III · ESHospital Universitario Reina Sofía · ESUnidade Integrada de Farmacologia e Gastroenterologia · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionInfections caused by carbapenemase-producing METHODS AND ANALYSIS: The KAPEDIS trial is a single-centre, randomised, double-blind, placebo-controlled, phase 2, superiority clinical trial of FMT for eradication of intestinal colonisation by KPC-Kp. One hundred and twenty patients with rectal colonisation by KPC-Kp will be randomised 1:1 to receive encapsulated lyophilised FMT or placebo. The primary outcome is KPC-Kp eradication at 30 days. Secondary outcomes are: (1) frequency of adverse events; (2) changes in KPC-Kp relative load within the intestinal microbiota at 7, 30 and 90 days, estimated by real-time quantitative PCR analysis of rectal swab samples and (3) rates of persistent eradication, KPC-Kp infection and crude mortality at 90 days. Participants will be monitored for adverse effects throughout the intervention. ETHICS AND DISSEMINATION: Ethical approval was obtained from Reina Sofía University Hospital Institutional Review Board (approval reference number: 2019-003808-13). Trial results will be published in peer-reviewed journals and disseminated at national and international conferences. TRIAL REGISTRATION NUMBER: NCT04760665.

Indexed as

Carbapenem-Resistant EnterobacteriaceaeKlebsiella InfectionsAnti-Bacterial AgentsBacterial Proteinsbeta-LactamasesFecal Microbiota TransplantationHumansKlebsiella pneumoniaeAnti-Bacterial AgentsBacterial Proteinsbeta-Lactamasescarbapenemaseinfection controlinfectious diseasespublic health

Identifiers

PMID35387830
PMCPMC8987760
OpenAlexW4223486717

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.