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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| xinzhijun | 1.5-3.0g,iv,bid or tid for 5-12 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| xinzhijun | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | the incidence(%)of allergies, skin rashes, shock,death, etc. | day0-day22-28 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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hospitalized patients or outpatients
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| Name | Affiliation | Role |
|---|---|---|
| lanjuan lj li, docter | Zhejiang University | Principal Investigator |
| changqing cq li, doctor | Chongqing Red Cross Hospital | Study Director |
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Third-generation cephalosporin resistant
post market
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| ID | Title | Description |
|---|---|---|
| FG000 | Xinzhijun | 1.5-3.0g,iv,bid or tid for 5-12 days xinzhijun: 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Xinzhijun | xinzhijun:third generation beta-lactam cephalosporin and beta lactamase inhibitors (BLIs) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events | the incidence(%)of allergies, skin rashes, shock,death, etc. | Posted | Count of Participants | Participants | day0-day22-28 |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Xinzhijun | 1.5-3.0g,iv,bid or tid for 5-12 days xinzhijun: 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Directer of clinical trials | xiangbei welman pharmacuticol CO.,LTD | 020-38868707 | gap@welman.com.cn |
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| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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|
| at weeks 4,day22-28 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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). | included all the participants | Posted | Count of Participants | Participants | at weeks 4,day22-28 |
|
|
|
|
| 0 |
| 2,032 |
| 0 |
| 2,032 |
| 70 |
| 2,032 |
| vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| pyrexia | Nervous system disorders | Systematic Assessment |
|
| ALT increased | Blood and lymphatic system disorders | Systematic Assessment |
|
| AST increaesd | Blood and lymphatic system disorders | Systematic Assessment |
|
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |