Evidence map›Paper›PMID 22752871›Full record

SynthesisClinical infectious diseases : an official publication of the Infectious Diseases Society of America2012

Fidaxomicin versus vancomycin for Clostridium difficile infection: meta-analysis of pivotal randomized controlled trials.

Derrick W Crook, A Sarah Walker, Yin Kean, Karl Weiss, Oliver A Cornely, Mark A Miller, Roberto Esposito, Thomas J Louie, Nicole E Stoesser, Bernadette C Young and 4 more

Open access · bronzeAbstract readMeta-AnalysisMulticenter Study
In one paragraph

Synthesis in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 96 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
96citing papers in PubMed, 3 pooled it
14.0field-weighted citation impact, top 1% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

96 citing papers in PubMed, 3 syntheses or guidelines pooled it, 255 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Guideline
  4. Trial
  5. Trial
  6. Review
  7. Metabolic Syndrome Is Associated With Increased Risk ofOpen forum infectious diseases · 2026
    Article
  8. Review
  9. Review
  10. Article
  11. Article
  12. Pathogens (Basel, Switzerland) · 2024
    Review
  13. Review
  14. Recurrent Clostridioides difficile Infection: Current Clinical Management and Microbiome-Based Therapies.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2023
    Review
  15. Article
  16. Review
  17. Retrospective Cohort Analysis of Outpatient Antibiotic Use forThe Canadian journal of infectious diseases & medical microbiology = Journal canadien des maladies infectieuses et de la microbiologie medicale · 2023
    Article
  18. Fidaxomicin for the Treatment ofAntibiotics (Basel, Switzerland) · 2022
    Review
  19. Article
  20. Validation of Clinical Risk Models for Clostridioides difficileAntimicrobial agents and chemotherapy · 2022
    Article

36 more citing papers are in PubMed but not listed here.

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

14 authors at 9 institutions in 5 countries.

Derrick W CrookNuffield Department of Medicine, Oxford University, Oxford, UK. derrick.crook@ndcls.ox.ac.uk
A Sarah Walker
Yin Kean
Karl Weiss
Oliver A Cornely
Mark A Miller
Roberto Esposito
Thomas J Louie
Nicole E Stoesser
Bernadette C Young
Brian J Angus
Sherwood L Gorbach
Timothy E A Peto
Study 003/004 Teams
Nuffield Foundation · GBAzienda Unita' Sanitaria Locale Di Modena · ITEdimer Pharmaceuticals (United States) · USHôpital Maisonneuve-Rosemont · CAJewish General Hospital · CAJohn Radcliffe Hospital · GBTufts University · USUniversity of Calgary · CAUniversity of Cologne · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Two recently completed phase 3 trials (003 and 004) showed fidaxomicin to be noninferior to vancomycin for curing Clostridium difficile infection (CDI) and superior for reducing CDI recurrences. In both studies, adults with active CDI were randomized to receive blinded fidaxomicin 200 mg twice daily or vancomycin 125 mg 4 times a day for 10 days. Post hoc exploratory intent-to-treat (ITT) time-to-event analyses were undertaken on the combined study 003 and 004 data, using fixed-effects meta-analysis and Cox regression models. ITT analysis of the combined 003/004 data for 1164 patients showed that fidaxomicin reduced persistent diarrhea, recurrence, or death by 40% (95% confidence interval [CI], 26%-51%; P < .0001) compared with vancomycin through day 40. A 37% (95% CI, 2%-60%; P = .037) reduction in persistent diarrhea or death was evident through day 12 (heterogeneity P = .50 vs 13-40 days), driven by 7 (1.2%) fidaxomicin versus 17 (2.9%) vancomycin deaths at <12 days. Low albumin level, low eosinophil count, and CDI treatment preenrollment were risk factors for persistent diarrhea or death at 12 days, and CDI in the previous 3 months was a risk factor for recurrence (all P < .01). Fidaxomicin has the potential to substantially improve outcomes from CDI.

Indexed as

AminoglycosidesAnti-Bacterial AgentsClostridioides difficileClostridium InfectionsDiarrheaEosinophilsFecesFidaxomicinHumansIntention to Treat AnalysisLeukocyte CountProportional Hazards ModelsProspective StudiesRandomized Controlled Trials as TopicRisk FactorsSecondary PreventionAminoglycosidesAnti-Bacterial AgentsFidaxomicinVancomycin

Identifiers

PMID22752871
PMCPMC3388031
OpenAlexW2149642295

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.