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Complicated Intra-abdominal InfectionsPhase 3IGNITE1NCT01844856

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

A Phase 3 study testing Eravacycline and Ertapenem in people with Complicated Intra-abdominal Infections, run by Tetraphase Pharmaceuticals, Inc at 69 sites in 13 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 of eravacycline compared with ertapenem in the treatment of adult complicated intra-abdominal infections (cIAI). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Complicated Intra-abdominal Infections
What is being tested?
Eravacycline and Ertapenem
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
541 participants
Where
69 sitesin 13 countries
Study dates
Aug 2013to Aug 2014
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 (and not over 65 years of age for participant in India)
  • 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 90 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 90 days following last study drug dose or practicing sexual abstinence

Who cannot join

  • Unlikely to survive the 6-8 week study period
  • Renal failure
  • Presence or possible signs of hepatic disease
  • Immunocompromised condition, including known human immunodeficiency virus (HIV) positivity (requiring anti-retroviral therapy or with CD4 count <300), acquired immune deficiency syndrome (AIDS), organ (bone marrow) transplant recipients, and hematological malignancy. Immunosuppressive therapy, including use of high-dose corticosteroids (for example, >40 mg prednisone or equivalent per day for greater than 2 weeks)
  • History of hypersensitivity reactions to tetracyclines, carbapenems, β-lactam antibiotics or to 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 disorder that may predispose to seizures or lower seizure threshold
  • Previously received eravacycline in a clinical trial
  • Antibiotic-related exclusions:
  • Receipt of effective antibacterial drug therapy for cIAI for a continuous duration of >24 hours during the 72-hour preceding enrollment (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 ertapenem or any other carbapenem, or tigecycline for the current infection or
  • Need for concomitant systemic antimicrobial agents 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

Trial locations and contacts

69 sites in 13 countries.

69 sites in 13 countries

United States19 sites

  • Study site

    Aurora, Illinois

  • Study site

    Boston, Massachusetts

  • Study site

    Camden, New Jersey

  • Study site

    Carmel, Indiana

  • Study site

    Cleveland, Ohio

  • Study site

    Columbus, Ohio

  • Study site

    Florence, Alabama

  • Study site

    Glendale, California

  • Study site

    Houston, Texas

  • Study site

    La Mesa, California

  • Study site

    Las Vegas, Nevada

  • Study site

    Los Angeles, California

  • Study site

    Minneapolis, Minnesota

  • Study site

    Mobile, Alabama

  • Study site

    Seattle, Washington

  • Study site

    Springfield, Massachusetts

  • Study site

    Teaneck, New Jersey

  • Study site

    Torrance, California

  • Study site

    Weston, Ohio

Other trials in United States

Russia9 sites

  • Study site

    Kaluga

  • Study site

    Kemerovo

  • Study site

    Moscow

  • Study site

    Nizhny Novgorod

  • Study site

    Saint Petersburg

  • Study site

    Smolensk

  • Study site

    Tomsk

  • Study site

    Volgograd

  • Study site

    Vsevolozhsk

Other trials in Russia

Ukraine7 sites

  • Study site

    Dnipropetrovsk

  • Study site

    Ivano-Frankivsk

  • Study site

    Kharkiv

  • Study site

    Kyiv

  • Study site

    Odesa

  • Study site

    Uzhhorod

  • Study site

    Zaporizhia

Other trials in Ukraine

Czechia6 sites

  • Study site

    Brno

  • Study site

    Kladno

  • Study site

    Mělník

  • Study site

    Olomouc

  • Study site

    Prague

  • Study site

    Ústí nad Labem

Other trials in Czechia

Bulgaria5 sites

  • Study site

    Pleven

  • Study site

    Plovdiv

  • Study site

    Rousse

  • Study site

    Sofia

  • Study site

    Varna

Other trials in Bulgaria

Lithuania4 sites

  • Study site

    Kaunas

  • Study site

    Klaipėda

  • Study site

    Šiauliai

  • Study site

    Vilnius

Other trials in Lithuania

Romania4 sites

  • Study site

    Bucharest

  • Study site

    Cluj-Napoca

  • Study site

    Craiova

  • Study site

    Timișoara

Other trials in Romania

South Africa4 sites

  • Study site

    Benoni

  • Study site

    Johannesburg

  • Study site

    Pretoria

  • Study site

    Worcester

Other trials in South Africa

Estonia3 sites

  • Study site

    Kohtla-Järve

  • Study site

    Tallinn

  • Study site

    Tartu

Other trials in Estonia

Germany3 sites

  • Study site

    Heidelberg

  • Study site

    Lübeck

  • Study site

    Magdeburg

Other trials in Germany

Latvia3 sites

  • Study site

    Daugavpils

  • Study site

    Liepāja

  • Study site

    Riga

Other trials in Latvia

Argentina1 site

  • Study site

    Córdoba

Other trials in Argentina

France1 site

  • Study site

    Paris

Other trials in France

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 Ertapenem 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 of eravacycline compared with ertapenem in the treatment of adult complicated intra-abdominal infections (cIAI).

Being tested
Eravacycline, Ertapenem, 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

  • ErtapenemDrug

    Also called Invanz

  • PlaceboDrug

    Administered IV to maintain the blind.

Study groups in NCT01844856
Study groupRoleWhat they receive
Eravacycline, 1.0 mg/kg q12hExperimentalEravacycline was administered intravenously (IV) at a dose of 1.0 milligram per kilogram of body weight (mg/kg) every 12 hours (q12h) for a minimum of 4 days and a maximum of 14 days. Eravacycline treatment was to be stopped when symptoms of complicated intra-abdominal infection (cIAI) resolved, there was treatment failure, or the maximum allowed number of infusion days was reached.
Receives: Drug: Eravacycline; Drug: Placebo
Ertapenem, 1.0 g q24hActive comparatorErtapenem was administered IV at a dose of 1.0 gram (g) every 24 hours (q24h) for a minimum of 4 days and a maximum of 14 days. Ertapenem treatment was to be stopped when symptoms of cIAI resolved, there was treatment failure, or the maximum allowed number of infusion days was reached.
Receives: Drug: Ertapenem; Drug: Placebo

What is being measured

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

  1. Clinical Response of Eravacycline and Ertapenem Treatment Arms at the Test-of-cure (TOC) Visit in the Microbiological Intent-to-treat (Micro-ITT) Population

    Clinical response was classified as cure (complete resolution or significant improvement of signs and symptoms of the index infection), failure (death related to complicated intra-abdominal infection [cIAI], unplanned surgical procedures or percutaneous drainage procedures, persisting or recurrent infection within the abdomen, postsurgical wound infection, or administration of effective concomitant antibacterial therapy), or indeterminate (outcome was neither cure nor failure, or assessment was not available). Participants who were failures at the End-of-Treatment (EOT) visit (within 24 hours of last dose) were considered failures at the TOC visit. The number of participants with a clinical response classification of cure, failure, or indeterminate is presented.

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

Secondary outcomes (2)

  1. Clinical Response of Eravacycline and Ertapenem Treatment Arms in the Modified Intent-to-treat (MITT) Population at the TOC Visit

    Clinical response was classified as cure (complete resolution or significant improvement of signs and symptoms of the index infection), failure (death related to complicated intra-abdominal infection [cIAI], unplanned surgical procedures or percutaneous drainage procedures, persisting or recurrent infection within the abdomen, postsurgical wound infection, or administration of effective concomitant antibacterial therapy), or indeterminate (outcome was neither cure nor failure, or assessment was not available). Participants who were failures at the EOT visit (within 24 hours of last dose) were considered failures at the TOC visit. The number of participants with a clinical response classification of cure, failure, or indeterminate is presented.

    Measured: TOC visit: 25-31 days after first dose

  2. Clinical Response of Eravacycline and Ertapenem Treatment Arms in the Clinically Evaluable (CE) Population at the TOC Visit

    Clinical response was classified as cure (complete resolution or significant improvement of signs and symptoms of the index infection), failure (death related to complicated intra-abdominal infection [cIAI], unplanned surgical procedures or percutaneous drainage procedures, persisting or recurrent infection within the abdomen, postsurgical wound infection, or administration of effective concomitant antibacterial therapy), or indeterminate (outcome was neither cure nor failure, or assessment was not available). Participants who were failures at the EOT visit (within 24 hours of last dose) were considered failures at the TOC visit. The number of participants with a clinical response classification of cure, failure, or indeterminate is presented.

    Measured: TOC visit: 25-31 days after first dose

Timeline

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

  1. First posted1 May 2013 (estimated)
  2. Study startAug 2013
  3. Primary completionAug 2014
  4. Study completionAug 2014

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
541 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01844856
Sponsor's protocol ID
TP-434-008
Acronym
IGNITE1
Status last verified
Dec 2021
First submitted
29 Apr 2013
Last updated
11 Jan 2022
Data monitoring committee
No

Publications

  • 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

  • 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 J, Evans D, Slepavicius A, Lee P, Marsh A, Tsai L, Sutcliffe JA, Horn P. Assessing the Efficacy and Safety of Eravacycline vs Ertapenem in Complicated Intra-abdominal Infections in the Investigating Gram-Negative Infections Treated With Eravacycline (IGNITE 1) Trial: A Randomized Clinical Trial. JAMA Surg. 2017 Mar 1;152(3):224-232. doi: 10.1001/jamasurg.2016.4237.

    PubMed 27851857

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Eravacycline and Ertapenem in people with Complicated Intra-abdominal Infections, run by Tetraphase Pharmaceuticals, Inc at 69 sites in 13 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 11 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 69 sites in United States, Russia, Ukraine, Czechia, Bulgaria and 8 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 21 Mar 2016). 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?

Clinical Response of Eravacycline and Ertapenem Treatment Arms at the Test-of-cure (TOC) Visit in the Microbiological Intent-to-treat (Micro-ITT) Population (time frame: TOC visit: 25-31 days after the 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 NCT01844856, which also lists 3 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 11 Jan 2022.

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