Evidence map›Paper›PMID 31819544›Full record

ArticleInfection and drug resistance2019

Designing A Pathogen-Focused Study To Address The High Unmet Medical Need Represented By Carbapenem-Resistant Gram-Negative Pathogens - The International, Multicenter, Randomized, Open-Label, Phase 3 CREDIBLE-CR Study.

Matteo Bassetti, Mari Ariyasu, Bruce Binkowitz, Tsutae Den Nagata, Roger M Echols, Yuko Matsunaga, Kiichiro Toyoizumi, Yohei Doi

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Infection and drug resistance, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02714595 (A Multicenter, Randomized, Open-label Clinical Study of S-649266 or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens), which is not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
1.8field-weighted citation impact, top 15% 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.

NCT02714595 phase3completednot on this map

A Multicenter, Randomized, Open-label Clinical Study of S-649266 or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens

TypeinterventionalSponsorShionogiRan2016 to 2019Enrolled152ConditionsHealthcare-associated Pneumonia (HCAP), Bloodstream Infections (BSI), Hospital Acquired Pneumonia (HAP), Complicated Urinary Tract Infection (cUTI)ArmsCefiderocol, Best Available Therapy
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 31 citations in OpenAlex.

  1. Pooled it
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  3. Article
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  7. Article
  8. Is it time to move away from polymyxins?: evidence and alternatives.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2021
    Review
  9. Article
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  11. Antimicrobial agents and chemotherapy · 2020
    Article
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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

8 authors at 5 institutions in 3 countries.

Matteo BassettiInfectious Diseases Clinic, Department of Medicine, University of Udine and Azienda Sanitaria Universitaria Integrata, Udine, Italy.
Mari AriyasuShionogi & Co., Ltd., Osaka, Japan.ORCID 0000-0002-5109-9448
Bruce BinkowitzShionogi Inc., Florham Park, NJ, USA.
Tsutae Den NagataShionogi & Co., Ltd., Osaka, Japan.
Roger M EcholsInfectious Disease Drug Development Consulting, LLC, Easton, CT, USA.
Yuko MatsunagaShionogi Inc., Florham Park, NJ, USA.
Kiichiro ToyoizumiShionogi Inc., Florham Park, NJ, USA.ORCID 0000-0002-4893-3526
Yohei DoiDivision of Infectious Diseases, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
Shionogi (United States) · USShionogi (Japan) · JPInfectious Disease Consultants · USUniversity of Pittsburgh · USUniversity of Udine · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Carbapenem-resistant (CR) Gram-negative infections, including those caused by Enterobacteriaceae and the non-fermenters, represent the greatest unmet need for new effective treatments. The clinical development of new antibiotics for the treatment of CR infections is challenging and should focus on the individual pathogens irrespective of the infection site. However, the drug approval pathway is generally infection-site specific and rarely includes such drug-resistant pathogens. To overcome this limitation, a streamlined clinical development program may include a pathogen-focused clinical study, such as the CREDIBLE-CR study, to meet the expectations of some health authorities (ie, the European Medicines Agency [EMA]) and the medical community. Cefiderocol is a novel siderophore cephalosporin designed to target CR pathogens, including CR strains of Enterobacteriaceae (CRE), CLINICALTRIALSGOV REGISTRATION: NCT02714595. EUDRA-CT REGISTRATION: 2015-004703-23.

Indexed as

best available therapycarbapenem resistancecefiderocolpathogen-focused study designrapid diagnosticsstreamlined/limited clinical development

Identifiers

PMID31819544
PMCPMC6877446
OpenAlexW2991087087

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.