CompletedPhase 3

Efficacy and Safety Study of Eravacycline Compared With Ertapenem in Participants With Complicated Urinary Tract Infections

United States, Austria, Bulgaria1,205 participantsStarted 2017-01

Plain-language summary

The purpose of this study is to assess the efficacy, safety, and pharmacokinetics of eravacycline compared to ertapenem in treating participants with complicated urinary tract infections (cUTI).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male or female participant with either:
. Pyelonephritis and normal urinary tract anatomy (approximately 50% of the total population), or
. cUTI with at least one of the following conditions associated with a risk for developing cUTI:
. At least 18 years of age at time of consent
. Able to provide informed consent
. At least two of the following signs or symptoms:
. Chills, rigors, or warmth associated with fever or hypothermia
. Flank pain (pyelonephritis) or pelvic pain (cUTI)

Exclusion criteria

. Use of systemic antibiotics effective in cUTI within 72 hours prior to enrollment except under the following circumstances:
. Participants with suspected acute cUTI who have received a single dose of effective non-study antibiotics for the acute cUTI
. Signs and symptoms of cUTI developed while on the antibiotic for another indication

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of Participants in the Micro-ITT Population Demonstrating Clinical Cure and Microbiologic Success at the EOI Visit

Timeframe: End of Infusion

Proportion of Participants in the Micro-ITT Population Demonstrating Clinical Cure and Microbiologic Success at the Test-Of-Cure (TOC) Visit

Timeframe: TOC visit (14-17 days after randomization)

Trial details

NCT IDNCT03032510

SponsorTetraphase Pharmaceuticals, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-12

Results submitted2019-07-12

View on ClinicalTrials.gov More Complicated Urinary Tract Infections trials