Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Antibiotic combo shows promise for kids with hospital pneumonia

NCT ID NCT04223752

Disease control Sponsor: Merck Sharp & Dohme LLC 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This early-stage study tested the safety of the antibiotic combination ceftolozane/tazobactam in 41 children with hospital-acquired pneumonia. The drug was given intravenously, with doses adjusted by age. Researchers monitored side effects and how the drug moved through the body. The goal was to see if the drug is safe enough for further testing in children.

What this could mean

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

Active substance
Ceftolozane/Tazobactam (antibiotic combination)
What this could lead to
If successful, this could provide a safe dosing option for treating hospital-acquired pneumonia in children.
What could go wrong
This is a very early (Phase 1) safety study with only 41 participants, so it cannot prove effectiveness. Side effects or lack of benefit may emerge in larger trials.

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

41 people

The number who actually took part.

Started

Apr 2020

Finished

Sep 2024

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

7 days 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: * Is hospitalized and anticipated to receive a minimum of 8 days of concomitant standard-of-care \[SOC\] antibiotic therapy for proven or suspected NP. * If male, is abstinent from heterosexual intercourse, or agrees to use contraception during the intervention period and for ≥30 days after the last dose of study intervention. * If female, is not pregnant or breastfeeding, or is not a woman of childbearing potential (WOCBP), or is a WOCBP using acceptable contraception, is a WOCBP with negative urine or serum pregnancy test within 48 hours of the first dose of study intervention, or is abstinent from heterosexual intercourse. Exclusion Criteria: * Has a documented history of any moderate or severe hypersensitivity (or allergic) reaction to any β-lactam antibacterial. * Participants 3 months to \<18 years of age: has moderate to severe impairment of renal function, defined as an estimated creatinine clearance (CrCL) \<50 mL/min/1.73 m2 based on the revised Schwartz equation or requirement for peritoneal dialysis, hemodialysis, or hemofiltration. * Participants \<3 months of age: has CrCL \<20 mL/min/1.73 m2 based on the revised Schwartz equation or requirement for peritoneal dialysis, hemodialysis, or hemofiltration. * Is receiving or is anticipated to receive piperacillin/tazobactam while receiving ceftolozane/tazobactam or has received piperacillin/tazobactam within 24 hours prior to the first dose of ceftolozane/tazobactam. * Has participated in any clinical study of a therapeutic investigational product within 30 days prior to the first dose of ceftolozane/tazobactam. * Has previous participation in any study of ceftolozane or ceftolozane/tazobactam. * Has any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the participant or the quality of study data. * Has any rapidly progressing disease or immediately life-threatening illness including acute hepatic failure or septic shock. * Has active immunosuppression.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Nosocomial pneumonia are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Healthcare-Associated Pneumonia nosocomial infection

As listed by the trial registrant

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

Nosocomial pneumonia

Contacts and locations

Locations

  • AdventHealth Orlando ( Site 1318)

    Orlando, Florida, 32803, United States

  • Children's Wisconsin ( Site 1321)

    Milwaukee, Wisconsin, 53226, United States

  • Ciensalud Ips S A S ( Site 1501)

    Barranquilla, Atlántico, 08001, Colombia

  • Clinica de la Costa S.A.S. ( Site 1500)

    Barranquilla, Atlántico, 080020, Colombia

  • Hippokration General Hospital of Thessaloniki ( Site 0400)

    Thessaloniki, Central Macedonia, 546 42, Greece

  • Hospital General de Medellin ( Site 1503)

    Medellín, Antioquia, 0500515, Colombia

  • Hospital Infantil de Mexico Federico Gomez-Infectious Diseases ( Site 1600)

    Mexico City, Mexico City, 06720, Mexico

  • Hospital Roberto del Río ( Site 1400)

    Santiago, Region M. de Santiago, 8380418, Chile

  • Hospital Universitario Sant Joan de Deu ( Site 1100)

    Esplugues de Llobregat, Barcelona, 08950, Spain

  • Institution of Pediatr Obstetr and Gynec NAMS of Ukraine ( Site 1203)

    Kyiv, Kyivska Oblast, 04050, Ukraine

  • Instituto Nacional de Pediatria-Unidad de Apoyo a la Investigación Clínica ( Site 1602)

    Mexico City, Mexico City, 04530, Mexico

  • Ivano-Frankivsk Regional Children Clinical Hospital ( Site 1204)

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018, Ukraine

  • Kharkiv City Children Hospital 16 ( Site 1200)

    Kharkiv, Kharkiv Oblast, 61075, Ukraine

  • Mayo Clinic in Rochester, Minnesota ( Site 1322)

    Rochester, Minnesota, 55902, United States

  • Montefiore Medical Center [Bronx, NY] ( Site 1313)

    New York, New York, 10467, United States

  • Morozovskaya Children City Clinical Hospital ( Site 0901)

    Moscow, Moscow, 119049, Russia

  • Oncomédica S.A.S ( Site 1506)

    Montería, Departamento de Córdoba, 230002, Colombia

  • SA Tallinna Lastehaigla/Tallinn Children's Hospital ( Site 0201)

    Tallinn, Harju, 13419, Estonia

  • SA Tartu Ulikooli Kliinikum Lastekliinik ( Site 0200)

    Tartu, Tartu, 50406, Estonia

  • SI Dnipropetrovsk Regional Children Clinical Hospital DOR ( Site 1205)

    Dnipro, Dnipropetrovsk Oblast, 49100, Ukraine

  • Sanford Children's Hospital ( Site 1301)

    Sioux Falls, South Dakota, 57105, United States

  • Smolensk Regional Clinical Hospital ( Site 0903)

    Smolensk, Smolensk Oblast, 214018, Russia

  • St. Olga Children City Hospital ( Site 0906)

    Saint Petersburg, Sankt-Peterburg, 194156, Russia

  • West Virginia University ( Site 1310)

    Morgantown, West Virginia, 26506, United States

More trials for these conditions

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