Evidence map›Paper›PMID 28480267›Full record

ArticleOpen forum infectious diseases2017

Primary Outcomes From a Phase 3, Randomized, Double-Blind, Active-Controlled Trial of Surotomycin in Subjects With

Vicente Boix, Richard N Fedorak, Kathleen M Mullane, Yves Pesant, Uschi Stoutenburgh, Mandy Jin, Adedayo Adedoyin, Laurent Chesnel, Dalya Guris, Kajal B Larson and 1 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Open forum infectious diseases, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01597505 (A Randomized, Double-Blinded, Active-Controlled Study of CB-183,315 in Patients With Clostridium Difficile Associated Diarrhea), which is not on this map. Cited by 32 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 1 pooled it
7.6field-weighted citation impact, top 2% 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.

NCT01597505 phase3completednot on this map

A Randomized, Double-Blinded, Active-Controlled Study of CB-183,315 in Patients With Clostridium Difficile Associated Diarrhea

TypeinterventionalSponsorCubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Ran2012 to 2015Enrolled606ConditionsClostridium Difficile InfectionArmsSurotomycin, Vancomycin, Placebo
3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 1 synthesis or guideline pooled it, 71 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Advances of Antimicrobial Peptides in the Treatment of Multidrug-Resistant Bacteria.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025
    Review
  5. Review
  6. Comparative effectiveness of different therapies forThe Lancet regional health. Europe · 2025
    Article
  7. Review
  8. Identification ofJournal of bacteriology · 2024
    Article
  9. Article
  10. Antimicrobial agents and chemotherapy · 2024
    Article
  11. Article
  12. European Practice for CDI Treatment.Advances in experimental medicine and biology · 2024
    Article
  13. Identification of DraRS inJournal of bacteriology · 2023
    Article
  14. Article
  15. Article
  16. Article
  17. Review
  18. Current trends in targeted therapy for drug-resistant infections.Applied microbiology and biotechnology · 2019
    Review
  19. Review
  20. Article
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 5 institutions in 3 countries.

Vicente BoixUnit of Infectious Diseases, Hospital General Universitario de Alicante, Instituto de Investigación Sanitaria de Alicante (ISABIAL) - Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO), Spain.
Richard N FedorakDivision of Gastroenterology, University of Alberta, Edmonton, Canada.
Kathleen M MullaneDepartment of Medicine, Section of Infectious Diseases and Global Health, University of Chicago, Illinois.
Yves PesantSt-Jerome Medical Research Inc., Saint-Jérôme, Quebec, Canada.
Uschi StoutenburghMerck & Co., Inc., Kenilworth, New Jersey.
Mandy JinMerck & Co., Inc., Kenilworth, New Jersey.
Adedayo AdedoyinMerck & Co., Inc., Kenilworth, New Jersey.
Laurent ChesnelMerck & Co., Inc., Kenilworth, New Jersey.
Dalya GurisMerck & Co., Inc., Kenilworth, New Jersey.
Kajal B LarsonMerck & Co., Inc., Kenilworth, New Jersey.
Yoshihiko MurataMerck & Co., Inc., Kenilworth, New Jersey.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USCegep de Saint Jerome · CAFundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana · ESUniversity of Alberta · CAUniversity of Chicago · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAlthough the incidence of

methodsIn this randomized, double-blind, active-controlled, multicenter, international trial, subjects with CDI confirmed by a positive toxin result were randomized to receive surotomycin (250 mg twice daily) or vancomycin (125 mg 4 times daily) orally for 10 days. The primary endpoints were clinical response at end of treatment and evaluation of surotomycin safety. The key secondary endpoints were clinical response over time and sustained clinical response through a 30- to 40-day follow-up period.

resultsIn total, 570 subjects were randomized and had confirmed CDI; 290 subjects received surotomycin and 280 subjects received vancomycin. Surotomycin clinical cure rates at end of treatment (surotomycin/vancomycin: 79.0%/83.6%; difference of -4.6%; 95% confidence interval, -11.0 to 1.9]), clinical response over time (stratified log-rank test,

conclusionsSurotomycin failed to meet the criteria for noninferiority versus vancomycin for the primary and key secondary endpoints in this trial.

Indexed as

antibioticClostridium difficile infectionsurotomycinvancomycin

Identifiers

PMID28480267
PMCPMC5414029
OpenAlexW2588484778

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.