Clinical Study on Monitoring the Plasma Concentration of Ceftazidime-Avibactam in Critically Ill Patients

• Sponsor: First Affiliated Hospital of Zhejiang University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05413343
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Anticipated Duration (Months): 8.9
• Patients Per Site Per Month: 3.4

Study Details

Study Description

Brief Summary

A observational study is conducting at the First Affiliated Hospital of the Medical College of Zhejiang University from January 1, 2022 to September 30, 2022. Patients with severe sepsis and treatment with Ceftazidime-Avibactam will be enrolled.

Blood samples at 0, 2, 4, 6, and 8 h after the first time and the steady state(5 times) of administration will be collected to detect plasma drug concentrations of ceftazidime avibactam.

Condition or Disease	Intervention/Treatment	Phase
Severe Sepsis	Drug: Ceftazidime-avibactam

Detailed Description

We will collect the blood samples at 0, 2, 4, 6, and 8 h after the first time and the steady state(5 times) of administration from the patients receive treatment with Ceftazidime-Avibactam to detect plasma drug concentrations of ceftazidime avibactam.The collected specimens will be stored in a refrigerator at 0-8 °C, centrifuges within 24 hours (4 °C, 4000 r/min, 10 min), and the supernatant will be collected in an EP tube and stored in a -80 °C refrigerator. Ultra-high performance liquid chromatography-mass spectrometry (UPLC-MS/MS) will be used to detect plasma drug concentrations of ceftazidime avibactam. According to the outcomes ,we will analyse the follwing items,(1)T>MIC,(2)Cmax/MIC,(3)AUC/MIC.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 30 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Clinical Study on Monitoring the Plasma Concentration of Ceftazidime-Avibactam in Critically Ill Patients
• Actual Study Start Date: Jan 1, 2022
• Anticipated Primary Completion Date: Sep 30, 2022
• Anticipated Study Completion Date: Sep 30, 2022

Outcome Measures

Primary Outcome Measures

1. plasma drug concentrations of ceftazidime avibacta [about 48 hours after the first administration]

   plasma drug concentrations of ceftazidime avibacta after the steady state(5 times) of administration

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

(1) Patients with severe sepsis and treated with ceftazidime avibactam,(2) Age ≥ 18 years,(3) The patient or authorized persons agree and sign the informed consent, (4) The patient's hemoglobin is greater than 70g/l during blood collection .

Exclusion Criteria:

(1)The length of ICU stay more than 48 hours,(2)The blood sample is hemolysis.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital,College of Medicine,Zhejiang University	Hangzhou	Zhejiang	China	310000

Sponsors and Collaborators

• First Affiliated Hospital of Zhejiang University

Investigators

• Study Chair: YongHong Xiao, PhD, First Affiliated Hospital of Zhejiang University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: First Affiliated Hospital of Zhejiang University
• ClinicalTrials.gov Identifier: NCT05413343
• Other Study ID Numbers: IIT20220488A
• First Posted: Jun 10, 2022
• Last Update Posted: Jun 10, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by First Affiliated Hospital of Zhejiang University: severe sepsis, ceftazidime avibactam, plasma drug concentration
• Additional relevant MeSH terms: Sepsis; Ceftazidime; Avibactam; Avibactam, ceftazidime drug combination

Study Results

No Results Posted as of Jun 10, 2022