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Effect of ceftazidime-avibactam on intestinal microflora of critically patients

Effect of ceftazidime-avibactam on intestinal microflora of critically patients

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058228
Enrollment
Unknown
Registered
2022-04-03
Start date
2022-05-01
Completion date
Unknown
Last updated
2023-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

infectious disease

Interventions

Group 1 :ceftazidime avibactam treatment

Sponsors

Shanghai Tenth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Before the start of the study, the patients or their legal representatives voluntarily sign an informed consent form approved by the ethics committee; 2. Age 18 to 80 years, male or female; 3. Patients in neurosurgical intensive care unit; 4. Hospitalized patients with clinical diagnosis of bacterial infection, and the results of bacterial culture are carbamate-resistant gram-negative bacteria (except Acinetobacter, Stenotrophomonas and Metalloenzyme).

Exclusion criteria

Exclusion criteria: 1. Known or suspected allergy to the active substance or any of the excipients listed in the (ingredients) item, cephalosporin antibiotics, other types of ß-lactam antibiotics (such as penicillin, monoamidocin or carbapenem) and other severe hypersensitivity; 2. Unstable vital signs or inability to collect samples; 3. Those with a history of alcohol abuse; 4. Those with a history of drug abuse; 5. Patients with moderate or severe renal impairment, that is, endogenous creatinine clearance (CrCL) = 5 times the upper limit of the reference value 3 days before enrollment, and total bilirubin or direct bilirubin >= 3 days before enrollment 2 times the upper limit of the reference value; 7. Anyone with any known disease that seriously affects the immune system, such as: history of human immunodeficiency virus (HIV) infection; or advanced hematological malignancies; or splenectomy; 8. Female pregnant (urine pregnancy test positive) and lactating patients; 9. The investigator believes that there may be any circumstances that may increase the risk of patients or interfere with clinical research; 10. Patients who have participated in this clinical study and used the study drug before enrollment.

Design outcomes

Primary

MeasureTime frame
intestinal microflora;

Countries

China

Contacts

Public ContactNi Min

Shanghai Tenth People's Hospital

momo111225@163.com+86 18917688625

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026