Evidence map›Paper›PMID 25487791›Full record

Trial reportAntimicrobial agents and chemotherapy2015

Assessment of time to clinical response, a proxy for discharge readiness, among hospitalized patients with community-acquired pneumonia who received either ceftaroline fosamil or ceftriaxone in two phase III FOCUS trials.

Thomas P Lodise, Antonio R Anzueto, David J Weber, Andrew F Shorr, Min Yang, Alexander Smith, Qi Zhao, Xingyue Huang, Thomas M File

2 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIIRandomized 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 2 registered trials, which are not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
1.7field-weighted citation impact, top 17% 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.

NCT00509106 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Safety and Efficacy of Ceftaroline Versus Ceftriaxone in the Treatment of Adult Subjects With Community-Acquired Pneumonia

TypeinterventionalSponsorForest LaboratoriesRan2007 to 2009Enrolled622ConditionsBacterial PneumoniaArmsCeftaroline fosamil for Injection, Ceftriaxone, Placebo
NCT00621504 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Safety and Efficacy of Ceftaroline Versus Ceftriaxone, With Adjunctive Clarithromycin, in the Treatment of Adult Subjects With Community-Acquired Pneumonia

TypeinterventionalSponsorForest LaboratoriesRan2008 to 2009Enrolled606ConditionsBacterial PneumoniaArmsCeftaroline fosamil for Injection, IV Ceftriaxone, Placebo, Clarithromycin
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 23 citations in OpenAlex.

  1. Ceftaroline.Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2021
    Pooled it
  2. Trial
  3. Ceftaroline in severe community-acquired pneumonia.Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2022
    Review
  4. Review
  5. Article
  6. Observational
  7. Article
  8. Article
  9. 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

9 authors at 6 institutions in 1 country.

Thomas P LodiseAlbany College of Pharmacy and Health Sciences, Albany, New York, USA Thomas.Lodise@acphs.edu.
Antonio R AnzuetoUniversity of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.
David J WeberUniversity of North Carolina, Chapel Hill, North Carolina, USA.
Andrew F ShorrDepartment of Pulmonary and Critical Care, Washington Hospital Center, Washington, DC, USA.
Min YangAnalysis Group, Inc., Boston, Massachusetts, USA.
Alexander SmithCerexa, Inc., Oakland, California, USA.
Qi ZhaoForest Research Institute, Jersey City, New Jersey, USA.
Xingyue HuangForest Research Institute, Jersey City, New Jersey, USA.
Thomas M FileSumma Health System, Akron, Ohio, USA Northeast Ohio Medical University, Rootstown, Ohio, USA.
Albany College of Pharmacy and Health Sciences · USAnalysis Group (United States) · USMedStar Washington Hospital Center · USNortheast Ohio Medical University · USThe University of Texas Health Science Center at San Antonio · USUniversity of North Carolina at Chapel Hill · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The primary driver of health care costs for patients with community-acquired pneumonia (CAP) is the hospital length of stay (LOS). Unfortunately, hospital LOS comparisons are difficult to make from phase III CAP trials because of their structured designs and prespecified treatment durations. However, an opportunity still exists to draw inferences about potential LOS differences between treatments through the use of surrogates for hospital discharge. The intent of this study was to quantify the time to a clinical response, a proxy for the time to discharge readiness, among hospitalized CAP patients who received either ceftaroline or ceftriaxone in two phase III CAP FOCUS clinical trials. On the basis of the Infectious Diseases Society of America and American Thoracic Society CAP management guidelines and recent FDA guidance documents for community-acquired bacterial pneumonia, a post hoc adjudication algorithm was constructed a priori to compare the time to a clinical response, a proxy for the time to discharge readiness, between patients who received ceftaroline or ceftriaxone. Overall, 1,116 patients (ceftaroline, n=562; ceftriaxone, n=554) from the pooled FOCUS trials met the selection criteria for this analysis. Kaplan-Meier analyses showed that ceftaroline was associated with a shorter time, measured in days, to meeting the clinical response criteria (P=0.03). Of the patients on ceftaroline, 61.0, 76.1, and 83.6% achieved a clinical response by days 3, 4, and 5, compared to 54.3, 69.8, and 79.3% of the ceftriaxone-treated patients. In the Cox regression, ceftaroline was associated with a shorter time to a clinical response (HR, 1.16, P=0.02). The methodology employed here provides a framework to draw comparative effectiveness inferences from phase III CAP efficacy trials. (The FOCUS trials whose data were analyzed in this study have been registered at ClinicalTrials.gov under registration no. NCT00621504 and NCT00509106.).

Indexed as

AdultAgedAnti-Bacterial AgentsCeftarolineCeftriaxoneCephalosporinsCommunity-Acquired InfectionsFemaleHumansMaleMiddle AgedPneumonia, BacterialTreatment OutcomeAnti-Bacterial AgentsCeftarolineCeftriaxoneCephalosporins

Identifiers

PMID25487791
PMCPMC4335888
OpenAlexW1970198299

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.