A Study to Learn About the Study Medicine Aztreonam-Avibactam (ATM-AVI) in Infants and Newborns Admitted in Hospitals With Bacterial Infection (CHERISH)

PHASE2RecruitingINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

September 25, 2024

Primary Completion Date

July 31, 2028

Study Completion Date

July 31, 2028

Conditions
Gram-negative Bacterial Infection
Interventions
DRUG

Part A: ATM-AVI Single Dose, Cohorts 1-4

Single intravenous infusion of aztreonam-avibactam over 3 hours to assess pharmacokinetics, safety, and toleration.

DRUG

Part B: Multiple-dose ATM-AVI, Cohorts 1-4

Multiple intravenous infusions of aztreonam-avibactam over 3 hours, repeated every 6-8 hours up to 14 days to assess pharmacokinetics, safety, toleration, and efficacy.

Trial Locations (23)

333

RECRUITING

Chang Gung Medical Foundation-Linkou Branch, Taoyuan District

407

RECRUITING

Taichung Veterans General Hospital, Taichung

1039

NOT_YET_RECRUITING

Sanatorio Sagrado Corazón, Ciudad Autónoma de Buenos Aires

4000

NOT_YET_RECRUITING

Hospital del Niño Jesús, San Miguel de Tucumán

27710

RECRUITING

Duke University - Main Hospital and Clinics, Durham

30046

RECRUITING

Hsinchu Municipal Mackay Children's Hospital, Hsinchu

40202

RECRUITING

Norton Children's Hospital, Louisville

RECRUITING

Novak Center for Children's Health, Louisville

RECRUITING

University of Louisville, Norton Children's Research Institute, Louisville

46202

RECRUITING

Riley Hospital for Children at Indiana University Health, Indianapolis

49202

RECRUITING

Schneider Children's Medical Center, Petah Tikva

77030

RECRUITING

Memorial Hermann Hospital - Texas Medical Center, Houston

RECRUITING

The University of Texas Health Science Center at Houston, Houston

80045

NOT_YET_RECRUITING

Children's Hospital Colorado, Aurora

92868

RECRUITING

Children's Hospital of Orange County, Orange

226030

RECRUITING

Medanta Hospital Lucknow, Lucknow

395002

RECRUITING

Nirmal Hospital Pvt Ltd., Surat

560074

RECRUITING

RajaRajeswari Medical College and Hospital, Bengaluru

700017

RECRUITING

Institute of Child Health, Kolkata

3109601

RECRUITING

Rambam Health Care Campus, Haifa

02111

RECRUITING

Tufts Medical Center, Boston

08901

RECRUITING

Bristol Myers Squibb Children's Hospital at Robert Wood Johnson University Hospital, New Brunswick

RECRUITING

Rutgers University, New Brunswick

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

AbbVie

INDUSTRY

lead

Pfizer

INDUSTRY