A PHASE 2A MULTICENTER, OBSERVER-BLINDED, RANDOMIZED 2 ARM STUDY TO INVESTIGATE PHARMACOKINETICS, SAFETY, TOLERABILITY AND EFFICACY OF INTRAVENOUS AZTREONAM-AVIBACTAM ± METRONIDAZOLE COMPARED TO BEST AVAILABLE THERAPY (BAT) IN PEDIATRIC PARTICIPANTS 9 MONTHS TO LESS THAN 18 YEARS OF AGE WITH SERIOUS GRAM-NEGATIVE BACTERIAL INFECTIONS INCLUDING COMPLICATED INTRA-ABDOMINAL INFECTION

Status: Recruiting
Location: See all (32) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The purpose of this study is to evaluate how Aztreonam (ATM) and Avibactam (AVI) are processed in pediatric participants. This study also aims to understand participant safety and effects in pediatric participants. The study is seeking participants who are: * 9 months to less than 18 years of age * Hospitalized * Suspected/known to have a gram-negative infection * Receiving intravenous (iv, given directly into a vein) antibiotics * Being treated for complicated infections of various body parts that includes the abdomen, urinary tract, blood stream, and lungs. * Participants will receive either ATM-AVI or best available therapy (BAT). * Both therapies will be given through a vein. * Participants with complicated abdominal infections will also receive iv Metronidazole (MTZ). Patients with cIAI and Cockayne Syndrome are excluded due to a risk of severe hepatotoxicity with the use of MTZ. - Participants on ATM-AVI treatment who have anaerobic infections will also receive iv MTZ at the study doctor's discretion. * The iv dose of ATM-AVI will be based on the participant's weight and kidney function. * The study doctor will determine the iv dose of BAT. * During the first 2 study days, participants on ATM-AVI therapy will have 5 blood draws in small quantities. * Starting on day 4, the study doctor will decide if participants may be switched to oral therapy. * Participants will receive a maximum of 14 days of ATM-AVI treatment. * After discharge from the hospital, 1 study visit may be required. * Depending on the participant's response, the study duration will be from 33 to 50 days. * The investigator will contact participants by phone 28 to 35 days after the last study treatment to check participants health status.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 9 months
Maximum Age: 17
Healthy Volunteers: f
View:

⁃ Participants must meet the following key inclusion criteria to be eligible for enrollment into the study:

• 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).

• Suspected/confirmed cIAI, cUTI, HAP/VAP, or BSI with gram-negative pathogens.

• Require hospitalization and IV antibiotic treatment.

Locations
United States
California
Rady Children's Hospital
RECRUITING
San Diego
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Mount Sinai Kravis Children´s Hospital
RECRUITING
New York
The Mount Sinai Hospital
RECRUITING
New York
Weill Cornell Medicine-New York Presbyterian Hospital
RECRUITING
New York
Tennessee
Le Bonheur Children's Hospital
RECRUITING
Memphis
Other Locations
China
Beijing Children's Hospital, Capital Medical University
NOT_YET_RECRUITING
Beijing
Chengdu Women and Children Center Hospital
NOT_YET_RECRUITING
Chengdu
The Children's Hospital of Chongqing Medical University
NOT_YET_RECRUITING
Chongqing
Guangzhou Women and Children's Medical Center
NOT_YET_RECRUITING
Guangzhou
Shanghai Children's Medical Center
RECRUITING
Shanghai
Greece
University General Hospital of Heraklion
RECRUITING
Heraklion
Ippokrateio General Hospital of Thessaloniki
RECRUITING
Thessaloniki
Hungary
Semmelweis Egyetem
RECRUITING
Budapest
Semmelweis Egyetem
RECRUITING
Budapest
India
RajaRajeswari Medical College and Hospital
RECRUITING
Bangalore
Institute of Child Health
RECRUITING
Kolkata
Medanta Hospital Lucknow
RECRUITING
Lucknow
Sahaydri Super Speciality Hospital, Nagar road
RECRUITING
Pune
Nirmal Hospital Pvt Ltd.
RECRUITING
Surat
Spain
Hospital Germans Trias i Pujol
RECRUITING
Badalona
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Hospital Universitario HM Monteprincipe
NOT_YET_RECRUITING
Boadilla Del Monte
Hospital Sant Joan de Déu
RECRUITING
Esplugues De Llobregat
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
Taiwan
Hsinchu Municipal Mackay Children's Hospital
RECRUITING
Hsinchu
National Taiwan University Hospital
RECRUITING
Taipei
Chang Gung Medical Foundation-Linkou Branch
RECRUITING
Taoyuan District
Turkey
Istanbul Universitesi Istanbul Tıp Fakultesi Hastanesi
ACTIVE_NOT_RECRUITING
Istanbul
S.B.Ü. Dr. Behçet Uz Çocuk Hastaliklari Ve Cerrahisi Eğitim Ve Araştirma Hastanesi
RECRUITING
Izmir
Cukurova Universty
RECRUITING
Sarçam
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2023-04-18
Estimated Completion Date: 2026-08-17
Participants
Target number of participants: 48
Treatments
Experimental: ATM-AVI
ATM-AVI administered iv every 6 or 8 hours and dosed according to participant's weight and kidney function for up to 14 days depending on response. At the investigator's discretion, the participant may be switched to oral therapy after 3 days of iv ATM-AVI therapy
Active_comparator: Best available therapy (BAT)
BAT will be selected by the investigator and administered iv. At the investigator's discretion, the participant may be switched to oral therapy after 3 days of iv BAT
Related Therapeutic Areas
Sponsors
Leads: Pfizer

This content was sourced from clinicaltrials.gov

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