Evidence map›Paper›PMID 35022730›Full record

Trial reportThe Journal of antimicrobial chemotherapy2022

Clinical and microbiological outcomes, by causative pathogen, in the ASPECT-NP randomized, controlled, Phase 3 trial comparing ceftolozane/tazobactam and meropenem for treatment of hospital-acquired/ventilator-associated bacterial pneumonia.

Ignacio Martin-Loeches, Jean-François Timsit, Marin H Kollef, Richard G Wunderink, Nobuaki Shime, Martin Nováček, Ülo Kivistik, Álvaro Réa-Neto, Christopher J Bruno, Jennifer A Huntington and 7 more

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

Trial report in The Journal of antimicrobial chemotherapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing 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.

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

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 20 citations in OpenAlex.

  1. Pooled it
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  5. Article
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  13. Ceftolozane-tazobactam in nosocomial pneumonia.Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2022
    Review
  14. Efficacy andFrontiers in cellular and infection microbiology · 2022
    Review
  15. 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

17 authors at 9 institutions in 8 countries.

Ignacio Martin-LoechesSt James's Hospital, Trinity College Dublin, James Street, Dublin 8, Ireland.
Jean-François TimsitUMR 1137, IAME, Université Paris Diderot, F75018, Paris, France.
Marin H KollefWashington University School of Medicine, 4523 Clayton Ave, Campus Box 8052, St. Louis, MO 63110, USA.
Richard G WunderinkNorthwestern University Feinberg School of Medicine, 303 East Superior St, Simpson Querrey 5th Floor, Suite 5-301, Chicago, IL 60611, USA.
Nobuaki ShimeHiroshima University, 1-2-3 Kasumi, Minami-ku, Hiroshima, 734-8551, Japan.
Martin NováčekGeneral Hospital of Kolin, Zizkova 146, Kolin 3, 280 00, Czech Republic.
Ülo KivistikNorth Estonia Medical Centre Foundation, Sütiste tee 19, Tallinn, Harjumaa 13419, Estonia.
Álvaro Réa-NetoUniversidade Federal do Paraná, Rua XV de Novembro, 1299 - Centro, Curitiba - PR, 80060-000, Brazil.
Christopher J BrunoMerck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ 07033, USA.
Jennifer A HuntingtonMerck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ 07033, USA.
Gina LinMerck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ 07033, USA.
Erin H JensenMerck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ 07033, USA.
Mary MotylMerck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ 07033, USA.
Brian YuMerck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ 07033, USA.
Davis GatesMerck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ 07033, USA.
Joan R ButtertonMerck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ 07033, USA.
Elizabeth G RheeMerck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ 07033, USA.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USHiroshima University · JPNorth Estonia Medical Centre · EENorthwestern University · USOblastní nemocnice Kolín · CZTrinity College Dublin · IEUniversidade Federal do Paraná · BRUniversité Paris Cité · FRWashington University in St. Louis · US

Funding

Technology CoreU19AI135964 · NIAID · NORTHWESTERN UNIVERSITY AT CHICAGO · PI LUIS A. Nunes AMARAL · 2018 to 2026
$24.7M
NIAID NIH HHS U19 AI135964
6 · The paper itself

Abstract

objectivesIn the ASPECT-NP trial, ceftolozane/tazobactam was non-inferior to meropenem for treating nosocomial pneumonia; efficacy outcomes by causative pathogen were to be evaluated.

methodsMechanically ventilated participants with hospital-acquired/ventilator-associated bacterial pneumonia were randomized to 3 g ceftolozane/tazobactam (2 g ceftolozane/1 g tazobactam) q8h or 1 g meropenem q8h. Lower respiratory tract (LRT) cultures were obtained ≤36 h before first dose; pathogen identification and susceptibility were confirmed at a central laboratory. Prospective secondary per-pathogen endpoints included 28 day all-cause mortality (ACM), and clinical and microbiological response at test of cure (7-14 days after the end of therapy) in the microbiological ITT (mITT) population.

resultsThe mITT population comprised 511 participants (264 ceftolozane/tazobactam, 247 meropenem). Baseline LRT pathogens included Klebsiella pneumoniae (34.6%), Pseudomonas aeruginosa (25.0%) and Escherichia coli (18.2%). Among baseline Enterobacterales isolates, 171/456 (37.5%) were ESBL positive. For Gram-negative baseline LRT pathogens, susceptibility rates were 87.0% for ceftolozane/tazobactam and 93.3% for meropenem. For Gram-negative pathogens, 28 day ACM [52/259 (20.1%) and 62/240 (25.8%)], clinical cure rates [157/259 (60.6%) and 137/240 (57.1%)] and microbiological eradication rates [189/259 (73.0%) and 163/240 (67.9%)] were comparable with ceftolozane/tazobactam and meropenem, respectively. Per-pathogen microbiological eradication for Enterobacterales [145/195 (74.4%) and 129/185 (69.7%); 95% CI: -4.37 to 13.58], ESBL-producing Enterobacterales [56/84 (66.7%) and 52/73 (71.2%); 95% CI: -18.56 to 9.93] and P. aeruginosa [47/63 (74.6%) and 41/65 (63.1%); 95% CI: -4.51 to 19.38], respectively, were also comparable.

conclusionsIn mechanically ventilated participants with nosocomial pneumonia owing to Gram-negative pathogens, ceftolozane/tazobactam was comparable with meropenem for per-pathogen 28 day ACM and clinical and microbiological response.

Indexed as

Anti-Bacterial AgentsPneumonia, BacterialCephalosporinsHospitalsHumansMeropenemMicrobial Sensitivity TestsProspective StudiesPseudomonas aeruginosaTazobactamVentilators, MechanicalAnti-Bacterial AgentsceftolozaneCephalosporinsMeropenemTazobactam

Identifiers

PMID35022730
PMCPMC9432134
OpenAlexW4206455938

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.