Evidence map›Paper›PMID 41586496›Full record

Trial reportAntimicrobial agents and chemotherapy2026

Imipenem/cilastatin/relebactam dosing regimen justification using exposure-efficacy analyses in participants with hospital-acquired bacterial pneumonia or ventilator-associated bacterial pneumonia in the RESTORE-IMI 2 phase 3 study.

Munjal Patel, Garrett Nieddu, C Andrew DeRyke, Katherine Young, Luke Francis Chen, Amanda Paschke, Matthew L Rizk, Ferdous Gheyas

Registry-linked trialAbstract readClinical Trial, Phase IIIEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02493764 (A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Study the Safety, Tolerability, and Efficacy of Imipenem/Cilastatin/Relebactam), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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.

NCT02493764 phase3completednot on this map

A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Study the Safety, Tolerability, and Efficacy of Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Piperacillin/Tazobactam in Subjects With Hospital-Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial Pneumonia

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2015 to 2019Enrolled537ConditionsBacterial PneumoniaArmsImipenem, Relebactam, Cilastatin, Piperacillin, Tazobactam
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Munjal PatelMerck & Co., Inc., Rahway, New Jersey, USA.ORCID 0000-0001-6892-0899
Garrett NiedduMerck & Co., Inc., Rahway, New Jersey, USA.
C Andrew DeRykeMerck & Co., Inc., Rahway, New Jersey, USA.ORCID 0000-0001-5942-9707
Katherine YoungMerck & Co., Inc., Rahway, New Jersey, USA.
Luke Francis ChenMerck & Co., Inc., Rahway, New Jersey, USA.
Amanda PaschkeMerck & Co., Inc., Rahway, New Jersey, USA.
Matthew L RizkMerck & Co., Inc., Rahway, New Jersey, USA.ORCID 0009-0005-5009-2139
Ferdous GheyasMerck & Co., Inc., Rahway, New Jersey, USA.

Funding

Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, New Jersey, USA NA
6 · The paper itself

Abstract

An exposure-efficacy analysis of the phase 3 RESTORE-IMI 2 study (NCT02493764) evaluated the relationship between plasma exposure of imipenem and relebactam and key efficacy endpoints (primary: 28-day all-cause mortality [ACM]; secondary: clinical response at early follow-up [EFU; 7-14 days after the end of treatment]) in adult participants with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) who received imipenem/cilastatin/relebactam 500/500/250 mg (IMI/REL). Participants from the IMI/REL treatment group in the microbiological-modified intent-to-treat population who had pharmacokinetic (PK) data and relevant baseline pathogen susceptibility data available were included (

Indexed as

Anti-Bacterial AgentsAzabicyclo CompoundsCilastatinHealthcare-Associated PneumoniaImipenemPneumonia, BacterialPneumonia, Ventilator-AssociatedAdultAgedbeta-Lactamase InhibitorsCilastatin, Imipenem Drug CombinationDrug CombinationsEscherichia coliFemaleHumansKlebsiella pneumoniaeAnti-Bacterial AgentsAzabicyclo Compoundsbeta-Lactamase InhibitorsCilastatinCilastatin, Imipenem Drug CombinationDrug CombinationsImipenemrelebactamexposure–efficacyimipenemnosocomial pneumoniapharmacokineticsrelebactam

Identifiers

PMID41586496
PMCPMC12959156

What OpenQuestion holds

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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.