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Complicated Intra-abdominal InfectionsPhase 3IGNITE4NCT02784704

Efficacy and Safety Study of Eravacycline Compared With Meropenem in Complicated Intra-abdominal Infections

A Phase 3 study testing Eravacycline and Meropenem in people with Complicated Intra-abdominal Infections and Complicated Appendicitis, run by Tetraphase Pharmaceuticals, Inc at 54 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a Phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy, safety, and pharmacokinetics (PK) of eravacycline compared with meropenem in the treatment of complicated intra-abdominal infections (cIAIs). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Eravacycline and Meropenem
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
500 participants
Where
54 sitesin 11 countries
Study dates
13 Oct 2016to 19 May 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female participant hospitalized for cIAI
  • At least 18 years of age
  • Evidence of a systemic inflammatory response
  • Abdominal pain or flank pain (with or without rebound tenderness), or pain caused by cIAI that is referred to another anatomic area
  • Able to provide informed consent
  • If male: must agree to use an effective barrier method of contraception during the study and for 14 days following the last dose if sexually active with a female of childbearing potential
  • If female, not pregnant or nursing or, if of childbearing potential: either will commit to use at least two medically accepted, effective methods of birth control (for example, condom, oral contraceptive, indwelling intrauterine device, hormonal implant /patch, injections, approved cervical ring) during study drug dosing and for 14 days following last study drug dose or practicing sexual abstinence

Who cannot join

  • Unlikely to survive the 6-8 week study period
  • Creatinine clearance of ≤50 milliliter (mL)/minute
  • Presence or possible signs of significant hepatic disease
  • Immunocompromised condition, including known human immunodeficiency virus (HIV) positivity, transplant recipients, and hematological malignancy
  • History of moderate or severe hypersensitivity reactions to tetracyclines, carbapenems, β-lactam antibiotics, or to any of the excipients contained in the study drug formulations
  • Participation in any investigational drug or device study within 30 days prior to study entry
Show all 16Show fewer
  • Known or suspected current central nervous system (CNS) disorder that may predispose to seizures or lower seizure threshold (for example, severe cerebral arteriosclerosis, epilepsy)
  • Antibiotic-related exclusions:
  • Receipt of effective antibacterial drug therapy for cIAI for a continuous duration of >24-hours during the 72-hours preceding randomization [however, participants with documented cIAI (that is, known baseline pathogen) who have received at least 72-hours of antibiotic therapy and are considered treatment failures may be enrolled. Treatment failure is defined as persistent fever and/or clinical symptoms; or the development of a new intra-abdominal abscess after ≥72-hours of antibiotic therapy], or
  • Receipt of meropenem or any other carbapenem, or tigecycline for the current infection, or
  • Need for concomitant systemic antimicrobial agents effective in cIAI other than study drug
  • Refusal of mechanical ventilation, dialysis or hemofiltration, cardioversion, or any other resuscitative measures and drug/fluid therapy at time of consent
  • Known or suspected inflammatory bowel disease or associated visceral abscess
  • The anticipated need for systemic antibiotics for a duration of more than 14 days
  • Systemic malignancy that required chemotherapy, immunotherapy, radiation therapy, or antineoplastic therapy within the previous 3 months or that is anticipated to begin prior to the Test-of-Cure (TOC) visit
  • Known at study entry to have cIAI caused by a pathogen(s) resistant to one of the study drugs

Trial locations and contacts

54 sites in 11 countries.

54 sites in 11 countries

Ukraine8 sites

  • Study site

    Dnipro

  • Study site

    Ivano-Frankivsk

  • Study site

    Kharkiv

  • Study site

    Kyiv

  • Study site

    Lviv

  • Study site

    Odesa

  • Study site

    Uzhhorod

  • Study site

    Vinnytsia

Other trials in Ukraine

Russia7 sites

  • Study site

    Arkhangelsk

  • Study site

    Kaluga

  • Study site

    Krasnodar

  • Study site

    Nizhny Novgorod

  • Study site

    Saint Petersburg

  • Study site

    Volgograd

  • Study site

    Vsevolozhsk

Other trials in Russia

United States6 sites

  • Study site

    Cleveland, Ohio

  • Study site

    Columbus, Ohio

  • Study site

    Indianapolis, Indiana

  • Study site

    Las Vegas, Nevada

  • Study site

    Los Angeles, California

  • Study site

    Somers Point, New Jersey

Other trials in United States

Bulgaria5 sites

  • Study site

    Pleven

  • Study site

    Plovdiv

  • Study site

    Rousse

  • Study site

    Sofia

  • Study site

    Varna

Other trials in Bulgaria

Romania5 sites

  • Study site

    Bucharest

  • Study site

    Cluj-Napoca

  • Study site

    Craiova

  • Study site

    Târgu Mureş

  • Study site

    Timișoara

Other trials in Romania

Czechia4 sites

  • Study site

    Jihlava

  • Study site

    Kladno

  • Study site

    Kolín

  • Study site

    Prague

Other trials in Czechia

Estonia4 sites

  • Study site

    Tallinn

  • Study site

    Tartu

  • Study site

    Viljandi

  • Study site

    Võru

Other trials in Estonia

Georgia4 sites

  • Study site

    Batumi

  • Study site

    Kutaisi

  • Study site

    Tbilisi

  • Study site

    Zugdidi

Other trials in Georgia

Hungary4 sites

  • Study site

    Győr

  • Study site

    Kaposvár

  • Study site

    Pécs

  • Study site

    Veszprém

Other trials in Hungary

Latvia4 sites

  • Study site

    Daugavpils

  • Study site

    Liepāja

  • Study site

    Rēzekne

  • Study site

    Riga

Other trials in Latvia

Lithuania3 sites

  • Study site

    Kaunas

  • Study site

    Klaipėda

  • Study site

    Vilnius

Other trials in Lithuania

About this study

Official title: 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

This is a Phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy, safety, and pharmacokinetics (PK) of eravacycline compared with meropenem in the treatment of complicated intra-abdominal infections (cIAIs).

Being tested
Eravacycline, Meropenem, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EravacyclineDrug

    Also called TP-434

  • MeropenemDrug

    Also called Merrem

  • PlaceboDrug

Study groups in NCT02784704
Study groupRoleWhat they receive
EravacyclineExperimentalNot described
Receives: Drug: Eravacycline; Drug: Placebo
MeropenemActive comparatorNot described
Receives: Drug: Meropenem; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With a Favorable Clinical Response at the Test-of-Cure (TOC) Visit in the Microbiological Intent-to-treat (Micro-ITT) Population

    Clinical cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no additional antibacterial therapy, surgical, or radiological intervention was required.

    Clinical failure was defined as death related to complicated intra-abdominal infection (cIAI), persistence of clinical symptoms of cIAI, unplanned surgical or percutaneous drainage procedures for complication or recurrence of cIAI, post-surgical wound infections requiring systemic antibiotics, or initiation of rescue antibacterial drug therapy for treatment of cIAI.

    Indeterminate/missing was defined as an outcome that was neither a clinical cure nor clinical failure, if the investigator did not complete an assessment, if a study visit was not conducted, or if the subject died for a cause unrelated to cIAI.

    Measured: TOC visit: 25-31 days after first dose of study drug

Secondary outcomes (2)

  1. Number of Participants With a Favorable Clinical Response at the Test-of-Cure (TOC) Visit in the All-Treated (MITT) Population

    Clinical cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no additional antibacterial therapy, surgical, or radiological intervention was required.

    Clinical failure was defined as death related to complicated intra-abdominal infection (cIAI), persistence of clinical symptoms of cIAI, unplanned surgical or percutaneous drainage procedures for complication or recurrence of cIAI, post-surgical wound infections requiring systemic antibiotics, or initiation of rescue antibacterial drug therapy for treatment of cIAI.

    Indeterminate/missing was defined as an outcome that was neither a clinical cure nor clinical failure, if the investigator did not complete an assessment, if a study visit was not conducted, or if the subject died for a cause unrelated to cIAI.

    Measured: TOC visit: 25-31 days after first dose of study drug

  2. Number of Participants With a Favorable Clinical Response at the Test-of-Cure (TOC) Visit in the Clinically Evaluable (CE) Population

    Clinical cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no additional antibacterial therapy, surgical, or radiological intervention was required.

    Clinical failure was defined as death related to complicated intra-abdominal infection (cIAI), persistence of clinical symptoms of cIAI, unplanned surgical or percutaneous drainage procedures for complication or recurrence of cIAI, post-surgical wound infections requiring systemic antibiotics, or initiation of rescue antibacterial drug therapy for treatment of cIAI.

    Measured: TOC visit: 25-31 days after first dose of study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2016 (estimated)
  2. Study start13 Oct 2016
  3. Primary completion8 May 2017
  4. Study completion19 May 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02784704
Sponsor's protocol ID
TP-434-025
Acronym
IGNITE4
Status last verified
Dec 2021
First submitted
23 May 2016
Last updated
6 Jan 2022
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Solomkin JS, Gardovskis J, Lawrence K, Montravers P, Sway A, Evans D, Tsai L. IGNITE4: Results of a Phase 3, Randomized, Multicenter, Prospective Trial of Eravacycline vs Meropenem in the Treatment of Complicated Intraabdominal Infections. Clin Infect Dis. 2019 Aug 30;69(6):921-929. doi: 10.1093/cid/ciy1029.

    PubMed 30561562

  • Solomkin JS, Sway A, Lawrence K, Olesky M, Izmailyan S, Tsai L. Eravacycline: a new treatment option for complicated intra-abdominal infections in the age of multidrug resistance. Future Microbiol. 2019 Oct;14:1293-1308. doi: 10.2217/fmb-2019-0135. Epub 2019 Oct 1.

    PubMed 31570004

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Eravacycline and Meropenem in people with Complicated Intra-abdominal Infections and Complicated Appendicitis, run by Tetraphase Pharmaceuticals, Inc at 54 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in Ukraine, Russia, United States, Bulgaria, Romania and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With a Favorable Clinical Response at the Test-of-Cure (TOC) Visit in the Microbiological Intent-to-treat (Micro-ITT) Population (time frame: TOC visit: 25-31 days after first dose of study drug). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02784704, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2022.

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