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New antibiotic under safety watch for hospital superbug

NCT ID NCT06746883

Disease control Sponsor: Innoviva Specialty Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is checking how safe the antibiotic sulbactam-durlobactam is for people hospitalized with a hard-to-treat bacterial infection called Acinetobacter baumannii. Researchers will watch 100 participants for about 28 days to see if they have any side effects, especially allergic reactions. The goal is to better understand the risks of this treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sulbactam-durlobactam (an antibiotic combination)
What this could lead to
If successful, this study could confirm that sulbactam-durlobactam is safe for treating serious bacterial infections, providing a reliable treatment option.
What could go wrong
This is an early observational study with only 100 participants, so results may not apply to everyone. The main focus is on safety, not effectiveness, and allergic reactions remain a risk.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Hospitalized participants

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participant is ≥18 years old at the time of written informed consent and is hospitalized. * Participant has provided the written informed consent. If a participant is unable to provide written informed consent due to their medical condition, the participant's legally authorized representative may consent on behalf of the participant, or the decision can be made according to the procedure permitted by local law and institutional standard operating procedures (SOPs). * Participant has a proven or strongly suspected diagnosis of an infection caused by susceptible ABC isolates, based on investigator's clinical judgment. * Participant initiates treatment with SUL-DUR per routine clinical care. Participants who receive SUL-DUR within 24 hours prior to enrollment are also eligible to participate. The decision to treat the participant with SUL-DUR is made prior to and independently of study participation. * The participant has an expected survival of \>48 hours at the time of written informed consent. Exclusion Criteria: * A history of significant hypersensitivity or allergic reaction to any β-lactam, or any contraindication to the use of β-lactam antibiotics

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Conditions

The condition(s) this trial relates to.

Acinetobacter infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acinetobacter baumannii-calcoaceticus complex infection (ABC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    12 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Montefiore Medical Group Family Care Center

    RECRUITING

    The Bronx, New York, 10467-2410, United States

  • Ochsner LSU Health Science Center Shreveport

    RECRUITING

    Shreveport, Louisiana, 71103-4228, United States

  • Ochsner Medical Center - New Orleans

    RECRUITING

    New Orleans, Louisiana, 70121-2429, United States

  • Prisma Health - Infectious Diseases - Greenville

    RECRUITING

    Greenville, South Carolina, 29605, United States

  • Summa Health System - Akron - 75 Arch Street

    RECRUITING

    Akron, Ohio, 44304-1430, United States

  • Tampa General Hospital

    RECRUITING

    Tampa, Florida, 33606, United States

  • The Carl and Edyth Lindner Center for Research and Education at Christ Hospital

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • UC Davis Health

    RECRUITING

    Sacramento, California, 95817, United States

  • University of Florida - Gainesville

    RECRUITING

    Gainesville, Florida, 32610-3003, United States

  • University of Kansas Medical Center-Kansas City-3901 Rainbow Blvd

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Kentucky College of Medicine

    RECRUITING

    Lexington, Kentucky, 40536-7001, United States

  • University of Pittsburg School of Medicine

    RECRUITING

    Pittsburgh, Pennsylvania, 15213-2500, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.