Respiratory Tract Infections, Urinary Tract Infections
Conditions
Keywords
Cefotaxime sulbactam sodium, Phase IV clinical studies, Respiratory and urinary tract infections
Brief summary
In the proposed study, the investigators plan to evaluate the efficacy and safety of Cefotaxime sodium and sulbactam sodium for injection (2:1)for the treatment of respiratory and urinary tract acute bacterial infection under the widely used in clinical conditions.
Detailed description
Cefotaxime is a third-generation cephalosporins.Cefotaxime sodium and sulbactam sodium for injection (2:1)plays a therapeutic role by the former inhibiting bacterial cell wall synthesis by irreversible competitive inhibition of β-lactamase.The antimicrobial effect of cefotaxime can be enhanced by the two combined.The compound specifically aims to the mechanism of bacterial resistance, extending the life of cefotaxime in the treatment-resistant pathogen infections.
Interventions
DRUGxinzhijun
durg:Cefotaxime sodium and sulbactam sodium for injection(2:1) 1.5-3.0g,iv,bid or tid for 5-12 days; Serious infections:1.0-1.5g,iv,tid or qid for 5-12 days
Sponsors
Xiangbei Welman Pharmaceutical Co., Ltd
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. Age\>18 years old, Gender: both 3. Women of childbearing age were to be negative pregnancy test and agree to take contraceptive measures during the trial; 4. patients were volunteers and signed informed consent form; 5. patients did not participate in other clinical trials.
Exclusion criteria
1. Patients were hypersusceptibility to the test drug or other penicillins ,β-lactamase inhibitor 2. Pregnant and Lactating women 3. Patients have severe liver,kidney,cardiovascular,cerebrovascular,endocrine and hematopoietic system of primary diseases and that of immunodeficiency,advanced cancer or mental illness. 4. Patients who were complicated by other diseases and thought to affect efficacy evaluations or poor compliance.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | day0-day22-28 | the incidence(%)of allergies, skin rashes, shock,death, etc. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Effect | at weeks 4,day22-28 | outcome:1.clinical cure 2. clinical failure population included patients who received the study drug, complied with the study protocol, did not have a missing or indeterminate clinical outcome response at the test-of-cure (TOC) visit, and had no confounding factors that interfered with the assessment of clinical outcome (e.g., use of nonstudy systemic antibiotic therapy on or after the first dose of the study drug for reasons other than treatment failure). |
Participant flow
Recruitment details
post market
Pre-assignment details
Third-generation cephalosporin resistant
Participants by arm
| Arm | Count |
|---|---|
| Xinzhijun xinzhijun:third generation beta-lactam cephalosporin and beta lactamase inhibitors (BLIs) | 2,032 |
| Total | 2,032 |
Baseline characteristics
| Characteristic | Xinzhijun |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 50 Participants |
| Age, Categorical Between 18 and 65 years | 1982 Participants |
| Race (NIH/OMB) Chinese American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Chinese Asian | 2032 Participants |
| Race (NIH/OMB) Chinese Black or African American | 0 Participants |
| Race (NIH/OMB) Chinese More than one race | 0 Participants |
| Race (NIH/OMB) Chinese Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Chinese Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Chinese White | 0 Participants |
| Region of Enrollment China | 2032 participants |
| Sex: Female, Male Female | 1250 Participants |
| Sex: Female, Male Male | 782 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2,032 |
| other Total, other adverse events | 70 / 2,032 |
| serious Total, serious adverse events | 0 / 2,032 |
Outcome results
Primary
Number of Participants With Adverse Events
the incidence(%)of allergies, skin rashes, shock,death, etc.
Time frame: day0-day22-28
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Xinzhijun | Number of Participants With Adverse Events | nausea | 10 Participants |
| Xinzhijun | Number of Participants With Adverse Events | vomiting | 4 Participants |
| Xinzhijun | Number of Participants With Adverse Events | diarrhea | 6 Participants |
| Xinzhijun | Number of Participants With Adverse Events | Pyrexia | 10 Participants |
| Xinzhijun | Number of Participants With Adverse Events | ALT increased | 25 Participants |
| Xinzhijun | Number of Participants With Adverse Events | AST increased | 15 Participants |
| Xinzhijun | Number of Participants With Adverse Events | no | 1962 Participants |
p-value: 0.05Fisher Exact
Secondary
Clinical Effect
outcome:1.clinical cure 2. clinical failure population included patients who received the study drug, complied with the study protocol, did not have a missing or indeterminate clinical outcome response at the test-of-cure (TOC) visit, and had no confounding factors that interfered with the assessment of clinical outcome (e.g., use of nonstudy systemic antibiotic therapy on or after the first dose of the study drug for reasons other than treatment failure).
Time frame: at weeks 4,day22-28
Population: included all the participants
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Xinzhijun | Clinical Effect | cure | 2022 Participants |
| Xinzhijun | Clinical Effect | failure | 10 Participants |
p-value: 0.01Fisher Exact