Precise Treatment of Ceftazidime-Avibactam in Patients With CRO Infections Under the Guidance of TDM and PPK Model

NCT06210542 | Not Yet Recruiting

• 1 other identifier: LPan20230579
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this study is to evaluate the efficacy and safety of ceftazidime-avibactam(CAZ-AVI) in the treatment of critically ill patients with carbapenem-resistant organisms(CRO) infections (including dialysis patients and extracorporeal membrane oxygenation(ECMO) patients).

Conditions

ECMO; Carbapenem-Resistant Enterobacteriaceae Infection

Outcome Measures

Primary Outcomes (2)

• Clinical success rate at the end of treatment and/or the time transfer out of ICU

  Clinical success includes cure or symptom improvement, which means that all symptoms and signs of patients have completely recovered or significantly improved before the end of treatment and/or the time transfer out of ICU, or imaging and other non-microbiological indicators have returned to normal. The proportion of patients with cured or improved symptoms in the total population was analyzed.

  the end of treatment or the time transfer out of ICU,up to 1 year.

• Microbiologic success rate at the end of treatment and/or the time transfer out of ICU

  Microbiological clearance includes clearance or presumed clearance. Clearance means that the pathogenic bacteria of the original infection have not been cultured from specimens from the original infected site after treatment; presumed clearance means that in some diseases, the disappearance of symptoms and signs makes it impossible to obtain culturable materials (such as sputum, skin pus or secretions). ), or the method of obtaining the specimen is too invasive for the recovered patient, the microbiological results are considered presumptive clearance. The microbial clearance rate is the proportion of patients who are cleared or presumed to be cleared to the total analyzed population.

  the end of treatment or the time transfer out of ICU,up to 1 year.

Secondary Outcomes (7)

• All-cause mortality on day 28 after drug initiation

  28 days from drug initiation

• Infection-related mortality during hospitalization in ICU

  the end of treatment or the time transfer out of ICU,up to 1 year.

• All-cause mortality on 90 days after drug initiation

  90 days from drug initiation

• Recurrence rate of infection on day 28 after starting medication

  28 days from drug initiation

• Length of ICU Stay

  the end of treatment or the time transfer out of ICU,up to 1 year.

Interventions

ceftazidime avibactam DRUG

Routine treatment dose for patients: the recommended intravenous dose for patients with creatinine clearance rate (eCrCL) \> 50ml/min was 2.5g (2g/0.5g), once every 8 hours, and the infusion time was 2 hours. Patients with renal injury adjust the dosage according to eCrCL

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

critically ill patients in ICU with CRO infections (including dialysis patients and ECMO patients).

You may qualify if:

• years old.
• Hospitalized participants in ICU who did not receive Ceftazidime Avibactam treatment within 15 days before joining the study.
• Participants with severe infection (refer to the 2022 sepsis3.0 guidelines for the definition of severe infection).
• at least one carbapenem-resistant Gram-negative pathogen (including but not limited to carbapenem-resistant Enterobacteriaceae and / or Pseudomonas aeruginosa) was confirmed by bacterial culture in the primary infection site samples.
• sufficient respiratory secretions, blood and peritoneal effusion can be obtained within 48 hours before the first administration for bacterial culture and drug sensitivity test.
• intravenous injection of Ceftazidime Avibactam for more than 72 hours.
• understand compliance with research procedures and methods, voluntarily participate in this study, and sign informed consent in writing.

You may not qualify if:

• Participants are less than 18.
• Death within 72 hours after the start of treatment.
• Known resistance to β-lactam antibacterial drugs including cephalosporins, cephalosporin compound preparations containing β-lactamase inhibitors, or Those with a history of allergies to ceftazidime avibactam sodium for injection and its excipients.
• No indication for treatment with ceftazidime avibactam.
• Pregnant and lactating women.

Sponsors & Collaborators

• Sichuan Provincial People's Hospital: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Interventions

avibactam, ceftazidime drug combination

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professor

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 18, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 18, 2024

Record last verified: 2024-01