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New hope for kids with tough infections: experimental antibiotic combo tested

NCT ID NCT05639647

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 02, 2026 · Updated 2 times

Summary

This study tests a new IV antibiotic (aztreonam-avibactam) in hospitalized children aged 9 months to 18 years with serious gram-negative bacterial infections. About 48 participants will receive either the new drug or the best available standard treatment. The goal is to see how the drug works in the body, check its safety, and see if it helps fight the infection. The study lasts up to 50 days and includes follow-up calls.

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

Apr 2023

Expected to finish

Mar 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

9 months 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 Participants must meet the following key inclusion criteria to be eligible for enrollment into the study: 1. Participants ≥9 months to \<18 years of age at Screening; Female (post-menarchal) participants must have a negative serum/urine pregnancy test (β hCG sensitivity ≥25 mIU/mL). 2. Suspected/confirmed cIAI, cUTI, HAP/VAP, or BSI with gram-negative pathogens. 3. Require hospitalization and IV antibiotic treatment. Exclusion Criteria Participants with any of the following characteristics/conditions will be excluded: 1. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. 2. Gram-negative species not expected to respond to ATM AVI ≤14 days. 3. Pregnant or breastfeeding; fertile male/female unwilling/unable to use effective contraception for at ≥7 days (males) or ≥28 days (females) after last ATM-AVI infusion. (HAP/VAP only): 4. Microbiologically known or high likelihood of monomicrobial infection with a gram-positive organism, lung abscess, pleural empyema, or post-obstructive pneumonia, lung or heart transplant. 5. Received \>24 hours of systemic antibiotics during the 48 hours before randomization unless participant has documented treatment failure after at least 48 hours of antibiotic therapy. 6. Current use of any prohibited concomitant medication(s) or unwilling/unable (Cockayne Syndrome patients with cIAI are excluded) to use MTZ or having received previous investigational drug(s) or vaccine ≤30 days or 5 half-lives before randomization (whichever is longer). 7. CrCL ≤15 mL/min/1.73 m2 (eCrCl or eGFR calculation based on age). 8. Non-infectious related screening ALT or AST \>3 x ULN, ALP \>3 x ULN and/or TBili \>2 x ULN (\> 3 x ULN for Gilbert's syndrome). 9. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

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Conditions

The condition(s) this trial relates to.

bacterial infectious disease with sepsis bacterial urinary tract infection gram-negative bacterial infections nosocomial infection

As listed by the trial registrant

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

Gram-negative bacterial infections

How to take part

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

  1. The places running it

    21 sites in 7 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

  • Beijing Children's Hospital, Capital Medical University

    RECRUITING

    Beijing, Beijing Municipality, 100045, China

  • Chang Gung Medical Foundation-Linkou Branch

    RECRUITING

    Taoyuan, 333, Taiwan

  • Cukurova Universty

    ACTIVE_NOT_RECRUITING

    Sarçam, Adana, 01250, Turkey (Türkiye)

  • Guangzhou Women and Children's Medical Center

    RECRUITING

    Guangzhou, Guangdong, 510623, China

  • Hospital Germans Trias i Pujol

    RECRUITING

    Badalona, Barcelona [barcelona], 08916, Spain

  • Hospital Sant Joan de Déu

    RECRUITING

    Esplugues de Llobregat, Barcelona [barcelona], 08950, Spain

  • Hospital Universitari Vall d'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario La Paz

    RECRUITING

    Madrid, Madrid, Comunidad de, 28046, Spain

  • Hsinchu Municipal Mackay Children's Hospital

    RECRUITING

    Hsinchu, Hsinchu, 300046, Taiwan

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • Institute of Child Health

    RECRUITING

    Kolkata, West Bengal, 700017, India

  • Ippokrateio General Hospital of Thessaloniki

    RECRUITING

    Thessaloniki, Kentrikí Makedonía, 546 42, Greece

  • Istanbul Universitesi Istanbul Tıp Fakultesi Hastanesi

    ACTIVE_NOT_RECRUITING

    Istanbul, İ̇stanbul, 34093, Turkey (Türkiye)

  • Medanta Hospital Lucknow

    RECRUITING

    Lucknow, Uttar Pradesh, 226030, India

  • National Taiwan University Hospital

    RECRUITING

    Taipei, 100225, Taiwan

  • Rady Children's Hospital

    RECRUITING

    San Diego, California, 92123, United States

  • RajaRajeswari Medical College and Hospital

    RECRUITING

    Bangalore, Karnataka, 560074, India

  • Semmelweis Egyetem

    RECRUITING

    Budapest, 1083, Hungary

  • Semmelweis Egyetem

    RECRUITING

    Budapest, 1094, Hungary

  • Shanghai Children's Medical Center

    RECRUITING

    Shanghai, 200127, China

  • University General Hospital of Heraklion

    RECRUITING

    Heraklion, Irakleío, 715 00, Greece

  • Weill Cornell Medicine-New York Presbyterian Hospital

    RECRUITING

    New York, New York, 10021, United States

More trials for these conditions

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