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New antibiotic studied in kids: first step toward better infection treatment

NCT ID NCT05217537

Knowledge-focused Sponsor: Paratek Pharmaceuticals Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-phase study tested a single dose of the antibiotic omadacycline (Nuzyra) in 23 children aged 8 to 17 who were hospitalized with bacterial infections. Researchers measured how the drug moved through the body and checked for side effects. The goal was to gather safety and dosing information, not to treat the infection.

What this could mean

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

Active substance
omadacycline (Nuzyra)
What this could lead to
If successful, this could help determine the right dose of omadacycline for children with bacterial infections.
What could go wrong
This is a very early, small study (23 children) that only looked at a single dose. It does not prove the drug works or is safe for long-term use.

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.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

23 people

The number who actually took part.

Started

Apr 2022

Finished

Feb 2025

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.

Ages

8 to 17 years

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: * Male or female subjects, age 8 to \< 18 (inclusive) who have written and signed parental/legal authorized representative (LAR) informed consent and pediatric assent. * Currently hospitalized with a suspected or confirmed bacterial infection and receiving or planned to receive systemic antibiotic therapy other than omadacycline. * Weight within the 5th and 95th percentile for age and sex. * Subjects must not be pregnant or nursing at the time of enrollment, and must agree to use a highly effective birth control method during the study Exclusion Criteria: * Evidence of a medical condition that may pose a safety risk or impair study participation. * Confirmed or suspected SARS-CoV-2 infection. * Has a history of hypersensitivity or allergic reaction to any tetracycline antibiotic. * Has received an investigational drug within the past 30 days.

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Conditions

The condition(s) this trial relates to.

bacterial infectious disease

As listed by the trial registrant

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

Bacterial infections

Contacts and locations

Locations

  • Site 105

    Chicago, Illinois, 60611, United States

  • Site 106

    Cleveland, Ohio, 60611, United States

  • Site 107

    Orange, California, 92868, United States

  • Site 108

    Houston, Texas, 77030, United States

  • Site 109

    Little Rock, Arkansas, 72202, United States

  • Site 111

    Greenville, North Carolina, 27858, United States

  • Site 112

    Long Beach, California, 90806, United States

  • Site 113

    Philadelphia, Pennsylvania, 19104, United States

  • Site 114

    Aurora, Colorado, 80045, United States

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