Neutropenia and Fever
Conditions
Interventions
Experimental group:Administered according to the recommended dosage in the prescribing information for Ceftazidime-Avibactam Sodium/Sodium Chloride Injection and the investigator's medical orders.
Sponsors
The Affiliated People's Hospital of NingboUniversity
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: The following conditions must be met for a subject to be included in this study: 1. Age >= 18 years at the time of screening; 2. The patient has persistent or recurrent fever: any one of the following conditions must be satisfied: (1) Oral temperature >= 38.3? or axillary temperature >= 38?; (2) Oral temperature >= 38?/axillary temperature >= 37.7? and lasting for more than 1 hour; 3. At the time of screening or within 48 hours, the neutrophil count <= 0.5 × 10^9/L; 4. Fully understands the content, process of the trial and possible adverse reactions, voluntarily participates in this trial, and signs the informed consent form; Those who do not meet any of the above conditions shall not be included as subjects.
Exclusion criteria
Exclusion criteria: Any of the following conditions shall be regarded as exclusion criteria: 1. Those who are allergic to cefotaxime avibactam sodium and its excipients; 2. Those with intractable blood stream infections related to internal implantations such as prostheses, devices, catheters, or artificial blood vessels; 3. Those who have received systemic treatment with cefotaxime/avibactam or its formulations within 10 days prior to screening; 4. Those with confirmed or clinically diagnosed invasive fungal diseases or those with known uncontrolled bacteremia, sepsis; 5. Those with an ECOG performance status score of 3 or higher during screening; 6. Those with compromised immune function, including those using other immunosuppressive drugs; 7. Those with abnormal liver function [aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >= 5 times the upper limit of normal, or ALT or AST elevated >= 3 times the upper limit of normal accompanied by total bilirubin >= 1.5 times the upper limit of normal, or total bilirubin >= 3 times the upper limit of normal]; 8. Those with serum creatinine > 2 times the upper limit of normal; 9. Those with clear evidence of infection by other microorganisms (fungi, viruses), or Gram-positive bacteria, or infection by resistant strains of cefotaxime avibactam sodium; 10. Those with an expected survival period of less than 2 months; 11. Those determined by the investigator to have any condition that may increase the risk of the trial, affect the subject's compliance with the protocol, or prevent the subject from completing the trial; 12. Pregnant or lactating women; 13. Patients determined by the investigator to be unsuitable for participation in this study, in addition to the above criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects who achieved clinical effectiveness at the EOT visit in the mITT population; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of subjects in the mITT population who achieved an early clinical response within 72 hours after the first dose;Adverse events, serious adverse events;Laboratory examination; Vital signs;Physical examination;12-lead electrocardiogram; | — |
Countries
China
Contacts
Public ContactShuangyue Li
The Affiliated People's Hospital of NingboUniversity
Outcome results
None listed