Evidence map›Paper›PMID 32094127›Full record

Trial reportAntimicrobial agents and chemotherapy2020

Comparison of Treatment Outcomes between Analysis Populations in the RESTORE-IMI 1 Phase 3 Trial of Imipenem-Cilastatin-Relebactam versus Colistin plus Imipenem-Cilastatin in Patients with Imipenem-Nonsusceptible Bacterial Infections.

Keith S Kaye, Helen W Boucher, Michelle L Brown, Angela Aggrey, Ireen Khan, Hee-Koung Joeng, Robert W Tipping, Jiejun Du, Katherine Young, Joan R Butterton and 1 more

Open access · greenAbstract readClinical Trial, Phase IIIComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 22% 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

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 33 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Article
  5. Review
  6. Article
  7. Article
  8. New antibiotics targeting Gram-negative bacilli.Le infezioni in medicina · 2025
    Review
  9. Review
  10. New Perspectives on Antimicrobial Agents: Imipenem-Relebactam.Antimicrobial agents and chemotherapy · 2022
    Review
  11. Review
  12. Review
  13. Review
  14. Review
  15. Pharmacokinetics of Non-β-Lactam β-Lactamase Inhibitors.Antibiotics (Basel, Switzerland) · 2021
    Review
  16. Review
  17. Review
  18. Review
  19. Review
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

11 authors at 3 institutions in 1 country.

Keith S KayeUniversity of Michigan, Ann Arbor, Michigan, USA.
Helen W BoucherTufts Medical Center, Boston, Massachusetts, USA.
Michelle L BrownMerck & Co., Inc., Kenilworth, New Jersey, USA.
Angela AggreyMerck & Co., Inc., Kenilworth, New Jersey, USA.
Ireen KhanMerck & Co., Inc., Kenilworth, New Jersey, USA.
Hee-Koung JoengMerck & Co., Inc., Kenilworth, New Jersey, USA.
Robert W TippingMerck & Co., Inc., Kenilworth, New Jersey, USA.
Jiejun DuMerck & Co., Inc., Kenilworth, New Jersey, USA.
Katherine YoungMerck & Co., Inc., Kenilworth, New Jersey, USA.
Joan R ButtertonMerck & Co., Inc., Kenilworth, New Jersey, USA.
Amanda PaschkeMerck & Co., Inc., Kenilworth, New Jersey, USA amanda.paschke@merck.com.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USTufts Medical Center · USUniversity of Michigan–Ann Arbor · US

Funding

Optimizing Clinical Use of Polymyxin B: Teaching an Old Drug to Treat SuperbugsR01AI119446 · NIAID · WAYNE STATE UNIVERSITY · PI LI, JIAN, POGUE, JASON MICHAEL · 2015 to 2019
$5.0M
NIAID NIH HHS R01 AI119446
6 · The paper itself

Abstract

The RESTORE-IMI 1 phase 3 trial demonstrated the efficacy and safety of imipenem-cilastatin (IMI) combined with relebactam (REL) for treating imipenem-nonsusceptible infections. The objective of this analysis was to compare the outcomes among patients meeting eligibility requirements based on central laboratory susceptibility versus local laboratory susceptibility. Patients with serious infections caused by imipenem-nonsusceptible, colistin-susceptible, and imipenem-REL-susceptible pathogens were randomized 2:1 to IMI-REL plus placebo or colistin plus IMI for 5 to 21 days. The primary endpoint was a favorable overall response. Key endpoints included the clinical response and all-cause mortality. We compared outcomes between the primary microbiological modified intent-to-treat (mMITT) population, where eligibility was based on central laboratory susceptibility testing, and the supplemental mMITT (SmMITT) population, where eligibility was based on local, site-level testing. The SmMITT (

Indexed as

AdultAgedAged, 80 and overAge FactorsAnti-Bacterial AgentsAzabicyclo Compoundsbeta-Lactamase InhibitorsCilastatin, Imipenem Drug CombinationColistinDrug Resistance, Multiple, BacterialEndpoint DeterminationFemaleGram-Negative Bacterial InfectionsHumansImipenemKidneyAnti-Bacterial AgentsAzabicyclo Compoundsbeta-Lactamase InhibitorsCilastatin, Imipenem Drug CombinationColistinImipenemrelebactamcarbapenem resistantlocal microbiology datasupplemental analysis populationβ-lactamase inhibitor

Identifiers

PMID32094127
PMCPMC7179630
OpenAlexW3007177012

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.