Evidence map›Paper›PMID 30561562›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2019

IGNITE4: Results of a Phase 3, Randomized, Multicenter, Prospective Trial of Eravacycline vs Meropenem in the Treatment of Complicated Intraabdominal Infections.

Joseph S Solomkin, Janis Gardovskis, Kenneth Lawrence, Philippe Montravers, Angie Sway, David Evans, Larry Tsai

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2019. 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 102 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
102citing papers in PubMed, 2 pooled it
6.4field-weighted citation impact, top 2% 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.

NCT01844856 phase3completednot on this map

A Phase 3, Randomized, Double-Blind, Double-Dummy, Multicenter, Prospective Study to Assess the Efficacy and Safety of Eravacycline Compared With Ertapenem in Complicated Intra-abdominal Infections

TypeinterventionalSponsorTetraphase Pharmaceuticals, IncRan2013 to 2014Enrolled541ConditionsComplicated Intra-abdominal InfectionsArmsEravacycline, Ertapenem, Placebo
NCT02784704 phase3completednot on this map

A Phase 3, Randomized, Double-Blind, Double-Dummy, Multicenter, Prospective Study to Assess the Efficacy and Safety of Eravacycline Compared With Meropenem in Complicated Intra-abdominal Infections

TypeinterventionalSponsorTetraphase Pharmaceuticals, IncRan2016 to 2017Enrolled500ConditionsComplicated Intra-abdominal Infections, Complicated AppendicitisArmsEravacycline, Meropenem, Placebo
3 · Its place in the literature

Who cites it

102 citing papers in PubMed, 2 syntheses or guidelines pooled it, 193 citations in OpenAlex.

  1. Prosthetic Valve Endocarditis byPathogens (Basel, Switzerland) · 2026
    Pooled it
  2. Pooled it
  3. Article
  4. Review
  5. Review
  6. Article
  7. Article
  8. The Rise in Carbapenem-ResistantPathogens (Basel, Switzerland) · 2026
    Review
  9. Review
  10. Polish journal of microbiology · 2026
    Article
  11. Review
  12. Article
  13. Article
  14. Review
  15. Article
  16. Review
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  18. Eravacycline: From broad-spectrum coverage to novel clinical applications.Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2026
    Review
  19. Article
  20. Review

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 5 institutions in 3 countries.

Joseph S SolomkinDepartment of Surgery, University of Cincinnati College of Medicine, Ohio.
Janis GardovskisDepartment of Surgery, Riga Stradins University, Latvia.
Kenneth LawrenceTetraphase Pharmaceuticals, Watertown, Massachusetts.
Philippe MontraversDépartement d'Anesthésie-Réanimation, CHU Bichat Claude Bernard.
Angie SwayWorld Surgical Infection Society, Cincinnati, Ohio.
David EvansDepartment of Surgery, Ohio State University School of Medicine, Columbus.
Larry TsaiTetraphase Pharmaceuticals, Watertown, Massachusetts.
Tetraphase Pharmaceuticals (United States) · USInserm · FRRiga Stradiņš University · LVThe Ohio State University · USUniversity of Cincinnati Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIncreasing antimicrobial resistance among pathogens that cause complicated intraabdominal infections (cIAIs) supports the development of new antimicrobials. Eravacycline, a novel member of the fluorocycline family, is active against multidrug-resistant bacteria including extended-spectrum β-lactamase (ESBL) and carbapenem-resistant Enterobacteriaceae.

methodsIGNITE4 was a prospective, randomized, double-blind trial. Hospitalized patients with cIAI received either eravacycline 1 mg/kg every 12 hours or meropenem 1 g every 8 hours intravenously for 4-14 days. The primary objective was to demonstrate statistical noninferiority (NI) in clinical cure rates at the test-of-cure visit (25-31 days from start of therapy) in the microbiological intent-to-treat population using a NI margin of 12.5%. Microbiological outcomes and safety were also evaluated.

resultsEravacycline was noninferior to meropenem in the primary endpoint (177/195 [90.8%] vs 187/205 [91.2%]; difference, -0.5%; 95% confidence interval [CI], -6.3 to 5.3), exceeding the prespecified margin. Secondary endpoints included clinical cure rates in the modified ITT population (231/250 [92.4%] vs 228/249 [91.6%]; difference, 0.8; 95% CI, -4.1, 5.8) and the clinically evaluable population (218/225 [96.9%] vs 222/231 [96.1%]; (difference, 0.8; 95% CI -2.9, 4.5). In patients with ESBL-producing Enterobacteriaceae, clinical cure rates were 87.5% (14/16) and 84.6% (11/13) in the eravacycline and meropenem groups, respectively. Eravacycline had relatively low rates of adverse events for a drug of this class, with less than 5%, 4%, and 3% of patients experiencing nausea, vomiting, and diarrhea, respectively.

conclusionsTreatment with eravacycline was noninferior to meropenem in adult patients with cIAI, including infections caused by resistant pathogens. CLINICAL TRIALS REGISTRATION: NCT01844856.

Indexed as

Anti-Bacterial AgentsDisease ManagementFemaleHumansIntraabdominal InfectionsMaleMeropenemTetracyclinesTime-to-TreatmentTreatment OutcomeAnti-Bacterial AgentseravacyclineMeropenemTetracyclinescomplicated intraabdominal infectionEnterobacteriaceaeeravacyclinegram-negative bacteriamultidrug resistance

Identifiers

PMID30561562
PMCPMC6735687
OpenAlexW2904230285

What OpenQuestion holds

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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.