Evidence map›Paper›PMID 22752859›Full record

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

Fidaxomicin attains high fecal concentrations with minimal plasma concentrations following oral administration in patients with Clostridium difficile infection.

Pamela Sears, Derrick W Crook, Thomas J Louie, Mark A Miller, Karl Weiss

Open access · bronzeAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report 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 42 papers.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed
5.0field-weighted citation impact, top 4% 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

42 citing papers in PubMed, 89 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Article
  7. mSphere · 2025
    Article
  8. Article
  9. Pathogens (Basel, Switzerland) · 2024
    Review
  10. Antibiotic Resistances of Clostridioides difficile.Advances in experimental medicine and biology · 2024
    Article
  11. Article
  12. Fidaxomicin for the Treatment ofAntibiotics (Basel, Switzerland) · 2022
    Review
  13. Antimicrobial resistance in Clostridioides difficile.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2021
    Review
  14. Antimicrobial agents and chemotherapy · 2021
    Article
  15. Article
  16. Fidaxomicin for the treatment ofFuture microbiology · 2020
    Article
  17. Role of Organic Solute Transporter Alpha/Beta in Hepatotoxic Bile Acid Transport and Drug Interactions.Toxicological sciences : an official journal of the Society of Toxicology · 2020
    Article
  18. Five-year Pan-European, longitudinal surveillance of Clostridium difficile ribotype prevalence and antimicrobial resistance: the extended ClosER study.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2020
    Article
  19. Article
  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

5 authors at 5 institutions in 3 countries.

Pamela SearsOptimer Pharmaceuticals, Inc., San Diego, California 92121, USA. psears@optimerpharma.com
Derrick W Crook
Thomas J Louie
Mark A Miller
Karl Weiss
Edimer Pharmaceuticals (United States) · USHôpital Maisonneuve-Rosemont · CAJewish General Hospital · CANuffield Orthopaedic Centre · GBUniversity of Calgary · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Fidaxomicin has recently been approved for the treatment of Clostridium difficile infection (CDI). As part of phase III studies, plasma and fecal samples were analyzed for concentrations of fidaxomicin and its metabolite, OP-1118. Plasma samples were collected before and after dose receipt on the first and last days of therapy, and fecal samples were collected on the last day of therapy. Samples were analyzed for fidaxomicin and OP-1118 (metabolite), using validated liquid chromatography/tandem mass spectrometric methods. Plasma concentrations were low for both fidaxomicin (mean [± standard deviation {SD}], 22.8 ± 26.7 ng/mL and 28.5 ± 33.4 ng/mL on the first and last days of therapy, respectively) and OP-1118 (mean [± SD], 44.5 ± 50.4 ng/mL and 85.6 ± 131 ng/mL, respectively). In contrast, fecal levels were >1000 µg/g for fidaxomicin and >800 µg/g for OP-1118. Fidaxomicin mean fecal levels were >5000 times the minimum inhibitory concentration for C. difficile of 0.25 µg/mL.

Indexed as

Administration, OralAgedAminoglycosidesAnti-Bacterial AgentsChromatography, LiquidClostridioides difficileClostridium InfectionsDouble-Blind MethodFecesFemaleFidaxomicinHumansMaleMiddle AgedSeverity of Illness IndexTandem Mass SpectrometryAminoglycosidesAnti-Bacterial AgentsFidaxomicinOP-1118Vancomycin

Identifiers

PMID22752859
PMCPMC3388019
OpenAlexW2155293017

What OpenQuestion holds

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LicenceCC BY-NC
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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.