Evidence map›Paper›PMID 23148736›Full record

Trial reportCritical care (London, England)2012

A randomized trial of 7-day doripenem versus 10-day imipenem-cilastatin for ventilator-associated pneumonia.

Marin H Kollef, Jean Chastre, Marc Clavel, Marcos I Restrepo, Bart Michiels, Koné Kaniga, Iolanda Cirillo, Holly Kimko, Rebecca Redman

3 registry-linked trialsOpen access · goldAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Critical care (London, England), 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 84 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
84citing papers in PubMed, 12 pooled it
14.3field-weighted citation impact, top 1% 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.

NCT00589693 phase3terminatednot on this map

A Prospective, Randomized, Double-Blind, Double-Dummy, Multicenter Study to Assess the Safety and Efficacy of Doripenem Compared With Imipenem-Cilastatin in the Treatment of Subjects With Ventilator-Associated Pneumonia

TypeinterventionalSponsorJohnson & Johnson Pharmaceutical Research & Development, L.L.C.Ran2008 to 2011Enrolled274ConditionsVentilator-Associated PneumoniaArmsDoripenem, Imipenem-Cilastatin, Placebo
NCT02634411 nacompletednot on this mapstarted 2016, after this paper: background citation

Impact of the Duration of Antibiotics on Clinical Events in Patients With Pseudomonas Aeruginosa Ventilator-associated Pneumonia : a Randomized Controlled Study (iDIAPASON)

TypeinterventionalSponsorAssistance Publique - Hôpitaux de ParisRan2016 to 2018Enrolled190ConditionsVentilator-Associated PneumoniaArms8 days of effective antibiotic treatment, 15 days of effective antibiotic treatment
NCT02685930 completednot on this mapstarted 2016, after this paper: background citation

Pneumonia in the Intensive Care Unit (ICU) Setting

TypeobservationalSponsorWashington University School of MedicineRan2016 to 2017Enrolled364ConditionsPneumonia, Respiratory FailureArmsAntibiotic de-escalation by ICU stewardship team with decreased exposure to broad spectrum antibiotics and shorter duration of therapy
3 · Its place in the literature

Who cites it

84 citing papers in PubMed, 12 syntheses or guidelines pooled it, 212 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Antibiotics for hospital-acquired pneumonia in neonates and children.The Cochrane database of systematic reviews · 2021
    Pooled it
  4. Pooled it
  5. Guideline
  6. Pooled it
  7. Antibiotics for ventilator-associated pneumonia.The Cochrane database of systematic reviews · 2016
    Pooled it
  8. Guideline
  9. Pooled it
  10. Guideline
  11. Pooled it
  12. A meta-analysis of efficacy and safety of doripenem for treating bacterial infections.The Brazilian journal of infectious diseases : an official publication of the Brazilian Society of Infectious Diseases
    Pooled it
  13. Trial
  14. Trial
  15. Trial
  16. Trial
  17. Trial
  18. Trial
  19. Article
  20. Article

24 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 6 institutions in 3 countries.

Marin H Kollef
Jean Chastre
Marc Clavel
Marcos I Restrepo
Bart Michiels
Koné Kaniga
Iolanda Cirillo
Holly Kimko
Rebecca Redman
Janssen (United States) · USHôpital Dupuytren · FRJanssen (Belgium) · BESorbonne Université · FRThe University of Texas Health Science Center at San Antonio · USWashington University in St. Louis · US

Funding

Effect of macrolides as immunomodulators in patients with sepsis and pneumoniaK23HL096054 · NHLBI · UNIVERSITY OF TEXAS HLTH SCIENCE CENTER · PI RESTREPO, MARCOS I. · 2010 to 2014
$689k
NHLBI NIH HHS K23 HL096054NHLBI NIH HHS K23HL096054
6 · The paper itself

Abstract

introductionThe aim of this study was to compare a 7-day course of doripenem to a 10-day course of imipenem-cilastatin for ventilator-associated pneumonia (VAP) due to Gram-negative bacteria.

methodsThis was a prospective, double-blinded, randomized trial comparing a fixed 7-day course of doripenem one gram as a four-hour infusion every eight hours with a fixed 10-day course of imipenem-cilastatin one gram as a one-hour infusion every eight hours (April 2008 through June 2011).

resultsThe study was stopped prematurely at the recommendation of the Independent Data Monitoring Committee that was blinded to treatment arm assignment and performed a scheduled review of data which showed signals that were close to the pre-specified stopping limits. The final analyses included 274 randomized patients. The clinical cure rate at the end of therapy (EOT) in the microbiological intent-to-treat (MITT) population was numerically lower for patients in the doripenem arm compared to the imipenem-cilastatin arm (45.6% versus 56.8%; 95% CI, -26.3% to 3.8%). Similarly, the clinical cure rate at EOT was numerically lower for patients with Pseudomonas aeruginosa VAP, the most common Gram-negative pathogen, in the doripenem arm compared to the imipenem-cilastatin arm (41.2% versus 60.0%; 95% CI, -57.2 to 19.5). All cause 28-day mortality in the MITT group was numerically greater for patients in the doripenem arm compared to the imipenem-cilastatin arm (21.5% versus 14.8%; 95% CI, -5.0 to 18.5) and for patients with P. aeruginosa VAP (35.3% versus 0.0%; 95% CI, 12.6 to 58.0).

conclusionsAmong patients with microbiologically confirmed late-onset VAP, a fixed 7-day course of doripenem was found to have non-significant higher rates of clinical failure and mortality compared to a fixed 10-day course of imipenem-cilastatin. Consideration should be given to treating patients with VAP for more than seven days to optimize clinical outcome.

trial registrationClinicalTrials.gov: NCT00589693.

Indexed as

AdolescentAdultAgedAged, 80 and overAnti-Bacterial AgentsCarbapenemsCilastatinDoripenemDouble-Blind MethodDrug Administration ScheduleDrug Therapy, CombinationFemaleHumansImipenemInfusions, IntravenousMaleAnti-Bacterial AgentsCarbapenemsCilastatinDoripenemImipenem

Identifiers

PMID23148736
PMCPMC3672596
OpenAlexW2150498285

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.