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

Trial Information
Who is this study for? Children with Nosocomial Pneumonia
What treatments are being studied? Ceftazidime-Avibactam
Status: Terminated
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
Summary

This is a multicenter, multinational, open label single dose pharmacokinetic (PK) study enrolling at least 32 subjects. The study aims to characterize the pharmacokinetics (PK) of a single intravenous dose of CAZ AVI in pediatric subjects aged 3 months to less than 18 years who are receiving systemic antibiotic therapy for suspected or confirmed nosocomial pneumonia, including ventilator associated pneumonia.

Am I eligible for this trial?
Participation Requirements
Sex:
All
Minimum Age:
3 months
Maximum Age:
17
Healthy Volunteers:
No

• Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:

• Evidence of a personally signed and dated informed consent document indicating that the subject's parent(s), legal guardian, or legally acceptable representative has been informed of all pertinent aspects of the study. As appropriate per local requirements informed assent of subjects must also be documented.

• Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

• Male or female children age ≥3 months to <18 years at Screening:

• Cohort 1: age 12 years to <18 years;

• Cohort 4: age 3 months to <2 years (must be born ≥37 weeks gestational age).

• Hospitalized, receiving systemic antibiotic therapy for the treatment of a suspected or confirmed HAP or VAP meeting the following criteria, and expected to require hospitalization until after the follow up evaluations are completed on Day 3 (48 hours after the end of infusion):

• Onset of symptoms ≥48 hours after admission or <7 days after discharge from an inpatient acute or chronic care facility;

• New or worsening infiltrate on chest X ray;

• At least 1 of the following systemic signs prior to the initiation of treatment for Nosocomial Pneumonia:

• i. Fever (temperature >38°C) or hypothermia (rectal/core temperature <35°C); ii. White blood cell (WBC) count >10,000 cells/mm3, or WBC count <4,500 cells/mm3, or >15% band forms.

• d. At least 2 of the following respiratory signs or symptoms: i. A new onset of cough (or worsening of cough). ii. Production of purulent sputum or endotracheal secretions. iii. Auscultatory findings consistent with pneumonia/pulmonary consolidation (eg, rales, rhonchi, bronchial breath sounds, dullness to percussion, egophony).

• iv. Dyspnea, tachypnea or hypoxemia (O2 saturation <90% or PaO2 <60 mmHg while breathing room air).

• v. A need for mechanical ventilation or, for already ventilated subjects, acute changes made in the ventilator support system to enhance oxygenation, as determined by, for example arterial blood gas or worsening PaO2/FiO2.

• Likely to survive the current illness or hospitalization.

• Sufficient IV access (peripheral or central) to receive study drug and dedicated access for PK sampling.

Where is this trial taking place?
Other Locations
China
Chengdu Women's and Children's Central Hospital
Chengdu
Wuxi Children's Hospital
Wuxi
Taiwan
Taipei Municipal Wanfang Hospital
Taipei
Chang Gung Memorial Hospital-Linkou
Taoyuan City
When is this trial taking place?
Start Date: June 15, 2020
Completion Date: May 7, 2021
How many participants will be in this trial?
Target number of participants: 4
What treatment is being studied in this trial?
Experimental: Ceftazidime-avibactam
This arm includes 4 cohorts
What other conditions are being studied in this trial?

This content was sourced from clinicaltrials.gov

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Who is this study for:Patients with Peritonitis, Pneumonia
Status:Recruiting
Start Date:October 1, 2018
Study Drug:Intravenous Infusion
Study Type:Drug
Phase: Phase 1
Clinical Research Regarding the Availability and Safety of UC-MSCs Treatment for Serious Pneumonia and Critical Pneumonia Caused by the 2019-nCOV Infection
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Status:Recruiting
Start Date:February 6, 2020
Study Drug:UC-MSCs
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