C3591025 CAZ-AVI in Bacterial Nosocomial Pneumonia including VABP
Research type
Research Study
Full title
A Phase 1, Open-label, Single-dose Study to Assess the Pharmacokinetics, Safety and Tolerability of Ceftazidime Avibactam (CAZ-AVI) in Children From 3 Months to Less Than 18 Years of Age Who are Hospitalized and Receiving Systemic Antibiotic Therapy for Suspected or Confirmed Nosocomial Pneumonia, Including Ventilator-Associated Pneumonia
IRAS ID
273434
Contact name
Margaret Tawadrous
Contact email
Sponsor organisation
Pfizer Inc.
Eudract number
2018-002841-12
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
US IND, 101,307
Duration of Study in the UK
0 years, 10 months, 2 days
Research summary
This study will explore how an experimental antibiotic combination treatment of ceftazidime and avibactam (CAZ-AVI) works in a paediatric population with confirmed or suspected bacterial infection called nosocomial pneumonia. Nosocomial pneumonia, also known as hospital-acquired pneumonia (HAP), is an infection in the lungs that can develop while children are in hospital or another health-care facility. Ceftazidime (CAZ) is a well-used injectable antibiotic that is susceptible to antibiotic resistance. Avibactam (AVI) by itself is not an antibiotic, but it can help overcome antibiotic resistance and make ceftazidime more effective for treating bacterial infections which otherwise might not respond to treatment with ceftazidime alone.
This study will focus on patients aged 3 months to <18 years who are hospitalized and receiving systemic antibiotic therapy for Nosocomial pneumonia including the subtype of ventilator-associated pneumonia (VAP). The purpose of the study is to learn about the safety of the study drug combination, CAZ-AVI, and how it is absorbed, distributed, broken down, and removed from the body. The other main purpose is to confirm the best dose for treating bacterial infections in patients.
The study is not randomized so all enrolled patients will receive a single dose of CAZ-AVI.
The study consists of one screening/baseline visit, followed by 2-3 days of hospitalization. After 4-5 weeks there will be a final follow-up visit or phone call. In addition to the visits listed, the study doctor may ask them to come in for extra visits if necessary to ensure their well-being.
There will be about 32 children taking part in this study. The study is being conducted at about 43 different study sites in 14 countries.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
19/YH/0380
Date of REC Opinion
25 Feb 2020
REC opinion
Further Information Favourable Opinion