Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT01601093
Eligibility Criteria:
Inclusion Criteria:
1. Patients who qualify for moderate and severe acute respiratory or urinary tract bacterial infection of acute bacterial infections need for systemic antibiotic therapy.
2. Hospital patients or good compliance clinic patients, who were more than 18 years old and less than 70 years old, Gender: both.
3. Patients who do not take other antibiotic medications before screening period.
4. Patients who have no severe liver, kidney and hematopoietic system of diseases (Both AST and ALT are less than 1.5 times of the upper limit of normal and Cr is in normal range)
5. Pathogenic bacteria was resistant to ceftazidime and sensitive to both of test drugs and contrast drugs.
6. Women of childbearing was to be negative pregnancy test and agree to take contraceptive measures during the trial.
7. Patients were volunteers and signed informed consent from.
Exclusion Criteria:
1. Patients were hypersusceptibility to the test drug or other penicillins ,β-lactamase inhibitor
2. Pathogenic bacteria was sensitive to ceftazidime or resistant to ceftazidime,test drugs and control drugs.
3. Patients who need to take other antibiotic medicine because of concurrent infection.
4. Patients who took medicine which affected efficacy evaluations and safety evaluations such as aspirin, indomethacin, phenylbutazone, sulfanilamide, disulfiram and probenecid in the trial.
5. Patients who took risks of severe drug interactions because of drug combination.
6. Patients who were complicated by other diseases and thought to affect efficacy evaluations or poor compliance.
7. Pregnant and Lactating women
8. Drug addicts and alcoholics.
9. Patients who once was selected in this trial.
10. Patients who participated in other clinical trials in the past three months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01601093
Study Brief:
Protocol Section:
NCT01601093