Evidence map›Paper›PMID 26248357›Full record

Trial reportAntimicrobial agents and chemotherapy2015

Multicenter, Double-Blind, Randomized, Phase 2 Study Evaluating the Novel Antibiotic Cadazolid in Patients with Clostridium difficile Infection.

Thomas Louie, Carl Erik Nord, George H Talbot, Mark Wilcox, Dale N Gerding, Martha Buitrago, Hilke Kracker, Pascal Charef, Oliver A Cornely

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01222702 (A Multi-center, Double-blind, Randomized, Active Reference, Parallel Group Study to Evaluate the Efficacy, Safety and Tolerability of a 10-day Twice Daily Oral Administration of Three Doses of Cadazolid), which is not on this map. Cited by 32 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 3 pooled it
8.2field-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.

NCT01222702 phase2completednot on this map

A Multi-center, Double-blind, Randomized, Active Reference, Parallel Group Study to Evaluate the Efficacy, Safety and Tolerability of a 10-day Twice Daily Oral Administration of Three Doses of Cadazolid (ACT-179811) in Subjects With Clostridium Difficile Associated Diarrhea (CDAD)

TypeinterventionalSponsorActelionRan2011 to 2012Enrolled84ConditionsClostridium Difficile InfectionArmsCadazolid, Vancomycin, Placebo-matching cadazolid, Placebo-matching vancomycin
3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 3 syntheses or guidelines pooled it, 71 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Review
  8. Review
  9. Reduced Vancomycin Susceptibility in Clostridioides difficile Is Associated With Lower Rates of Initial Cure and Sustained Clinical Response.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024
    Article
  10. Demonstration ofMicrobiology spectrum · 2021
    Article
  11. Antimicrobial agents and chemotherapy · 2021
    Article
  12. Review
  13. Article
  14. Article
  15. Review
  16. Review
  17. Prevention and treatment ofHuman vaccines & immunotherapeutics · 2019
    Review
  18. Review
  19. Management ofTherapeutic advances in gastroenterology · 2019
    Review
  20. 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

9 authors at 7 institutions in 6 countries.

Thomas LouieUniversity of Calgary, Calgary, Alberta, Canada thomas.louie@albertahealthservices.ca.
Carl Erik NordKarolinska Institute, Stockholm, Sweden.
George H TalbotTalbot Advisors, Anna Maria, Florida, USA.
Mark WilcoxLeeds General Infirmary, Leeds, United Kingdom.
Dale N GerdingLoyola University, Maywood, Illinois, USA.
Martha BuitragoIdaho Falls Infectious Diseases, Idaho Falls, Idaho, USA.
Hilke KrackerActelion Pharmaceuticals Ltd., Allschwil, Switzerland.
Pascal CharefActelion Pharmaceuticals Ltd., Allschwil, Switzerland.
Oliver A CornelyDepartment of Internal Medicine, Clinical Trials Centre Cologne, ZKS Köln, Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), University of Cologne, Cologne, Germany.
Actelion (Switzerland) · CHCologne Excellence Cluster on Cellular Stress Responses in Aging Associated Diseases · DEHealthcentric Advisors · USKarolinska Institutet · SELeeds General Infirmary · GBLoyola University Chicago · USUniversity of Calgary · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Cadazolid, a novel fluoroquinolone-oxazolidinone antibiotic, exhibits potent in vitro activity against Clostridium difficile, including the epidemic BI/NAP1/027 strain. This multicenter, randomized, double-blind, active reference group, phase 2 study evaluated the efficacy and safety of oral cadazolid in treatment of adult patients with C. difficile infection (CDI). Eligible patients with first occurrence/first recurrence of CDI were randomized 1:1:1:1 to 250, 500, or 1,000 mg cadazolid twice daily (BID) or oral 125 mg vancomycin four times daily (QID) for 10 days. The primary endpoint was clinical cure at test of cure (48 ± 24 h after the end of treatment; modified intent-to-treat population), defined as resolution of diarrhea with no further CDI treatment required. Secondary endpoints included recurrence rate, sustained clinical response (clinical cure without recurrence), and time to diarrhea resolution. Of 84 patients enrolled, 20, 22, 20, and 22 received 250, 500, or 1,000 mg cadazolid BID or 125 mg vancomycin QID, respectively. The primary endpoint was achieved in 76.5% (80% confidence interval [CI], 58.4, 89.3), 80.0% (63.9, 91.0), 68.4% (51.1, 82.5), and 68.2% (52.3, 81.3) of patients, respectively. There was no evidence of a cadazolid dosage-dependent response. Each dosage of cadazolid resulted in a lower recurrence rate than with vancomycin (18.2 to 25.0% versus 50%). Consequently, higher sustained clinical response rates were observed with cadazolid (46.7 to 60.0%) than with vancomycin (33.3%). The times to diarrhea resolution were similar for cadazolid and vancomycin. Cadazolid was well tolerated, with no safety signal observed. The results of this phase 2 study support further clinical development of cadazolid. (This study has been registered in the United States at ClinicalTrials.gov under registration no. NCT01222702 and in Europe with the European Medicines Agency under registration no. EUDRA-CT 2010-020941-29.).

Indexed as

Administration, OralAdultAgedAnti-Bacterial AgentsClostridioides difficileClostridium InfectionsDiarrheaDouble-Blind MethodDrug Administration ScheduleFemaleHumansMaleMiddle AgedOxazolidinonesPatient SafetyRecurrenceAnti-Bacterial AgentscadazolidOxazolidinonesVancomycin

Identifiers

PMID26248357
PMCPMC4576054
OpenAlexW2119031245

What OpenQuestion holds

Textmetadata
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.