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New antibiotic cocktail aimed at Drug-Resistant infections in babies

NCT ID NCT06462235

Disease control Sponsor: Pfizer 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a combination of two antibiotics, aztreonam and avibactam, in newborns and infants up to 9 months old who have serious infections caused by gram-negative bacteria. The trial has two parts: one to see how a single dose moves through the body, and another to test multiple doses over up to 14 days. Researchers will monitor safety and how well the drug works, aiming to find a better treatment for these tough infections in young babies.

What this could mean

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

Active substance
aztreonam and avibactam (antibiotic combination, with or without metronidazole)
What this could lead to
If successful, this could provide a safe and effective antibiotic option for hard-to-treat bacterial infections in very young infants.
What could go wrong
This is an early Phase 2 trial with only 48 participants, so results may not apply to all infants. The drug combination may still cause side effects or not work as well as hoped.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 48 people

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

Started

Sep 2024

Expected to finish

Apr 2027

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.

Ages

Up to 39 weeks

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 Participants must meet the following key inclusion criteria to be eligible for enrollment into the study: 1. Hospitalized with age from birth \<9 months, including preterm birth 2. Part A: Receiving IV antibiotics for treatment of suspected or confirmed bacterial infection, including but not limited to cIAI, cUTI, HAP/VAP, BSI, or sepsis. 3. Part B: Suspected or confirmed gram-negative bacterial infection requiring IV antibiotics, including but not limited to cIAI, cUTI, HAP/VAP, BSI, or sepsis. Participants with any of the following characteristics/conditions will be excluded: 1. Received any other investigational medicinal product within the longer of 30 days or 5 half-lives before enrollment. 2. Any medical or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. 3. Severe renal impairment or known significant renal disease, as evidenced by elevated serum creatinine at screening, or urinary output \<0.5 mL/kg/h for 6 consecutive hours or requirement for dialysis. 4. Part B Only: Received \>24 hours of systemic antibiotic treatment for gram-negative organisms at time of enrollment, unless documented treatment failure or lack of improvement in at least one objective sign or symptom of infection after ≥48 hours of antibiotics.

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Conditions

The condition(s) this trial relates to.

gram-negative bacterial infections

As listed by the trial registrant

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

Gram-negative bacterial infection

How to take part

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

  1. The places running it

    26 sites in 5 countries. 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

  • Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital

    RECRUITING

    Taoyuan, 33305, Taiwan

  • Children's Hospital Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Children's Hospital of Orange County

    RECRUITING

    Orange, California, 92868, United States

  • Children's Hospital of Orange County Southwest Tower

    RECRUITING

    Orange, California, 92868, United States

  • Clinica Del Niño Y La Madre

    RECRUITING

    Mar del Plata, Buenos Aires, 7600, Argentina

  • Clinica Privada del Sol S.A

    RECRUITING

    Córdoba, Córdoba Province, X5000IIH, Argentina

  • Duke University - Main Hospital and Clinics

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Hospital del Niño Jesús

    RECRUITING

    San Miguel de Tucumán, Tucumán Province, 4000, Argentina

  • Hsinchu Municipal Mackay Children's Hospital

    RECRUITING

    Hsinchu, Hsinchu, 300046, Taiwan

  • Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

    RECRUITING

    Hualien City, Hualien, 970, Taiwan

  • Institute of Child Health

    RECRUITING

    Kolkata, West Bengal, 700017, India

  • Medanta Hospital Lucknow

    RECRUITING

    Lucknow, Uttar Pradesh, 226030, India

  • Memorial Hermann Hospital - Texas Medical Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Nirmal Hospital Pvt Ltd.

    RECRUITING

    Surat, Gujarat, 395002, India

  • Norton Children's Hospital

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • Novak Center for Children's Health

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • RajaRajeswari Medical College and Hospital

    RECRUITING

    Bengaluru, Karnataka, 560074, India

  • Rambam Health Care Campus

    RECRUITING

    Haifa, Northern District, 3109601, Israel

  • Riley Hospital for Children at Indiana University Health

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Sahyadri Super Speciality Hospital

    RECRUITING

    Pune, Maharashtra, 411006, India

  • Sanatorio Sagrado Corazón

    RECRUITING

    Ciudad Autónoma de Buenos Aires, Buenos Aires, 1039, Argentina

  • Schneider Children's Medical Center

    RECRUITING

    Petah Tikva, Central District, 49202, Israel

  • Taichung Veterans General Hospital

    RECRUITING

    Taichung, 407, Taiwan

  • The University of Texas Health Science Center at Houston

    RECRUITING

    Houston, Texas, 77030, United States

  • Tufts Medical Center

    RECRUITING

    Boston, Massachusetts, 02111, United States

  • University of Louisville, Norton Children's Research Institute

    RECRUITING

    Louisville, Kentucky, 40202, United States

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