An observational study in Respiratory Tract Infections and Urinary Tract Infections, sponsored by Xiangbei Welman Pharmaceutical Co., Ltd. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-04.
Sponsored by Xiangbei Welman Pharmaceutical Co., Ltd · Observational
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 2,032 is above the median of 240 across 2,136 observational studies indexed under Infections.
Browse Infections studies →Xiangbei Welman Pharmaceutical Co., Ltd is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
hospitalized patients or outpatients
Exclusion Criteria:
1.5-3.0g,iv,bid or tid for 5-12 days
Drug: 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
Also known as: Experimental, shumate
Number of Participants With Adverse Events
the incidence(%)of allergies, skin rashes, shock,death, etc.
Time frame: day0-day22-28
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
post market
| Milestone | Xinzhijun |
|---|---|
| Started | 2032 |
| Completed | 2032 |
| Not completed | 0 |
the incidence(%)of allergies, skin rashes, shock,death, etc.
| Participants | Xinzhijun |
|---|---|
| nausea | 10 |
| vomiting | 4 |
| diarrhea | 6 |
| Pyrexia | 10 |
| ALT increased | 25 |
| AST increased | 15 |
| no | 1962 |
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).
| Participants | Xinzhijun |
|---|---|
| cure | 2022 |
| failure | 10 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Xinzhijun | 0/2,032 (0%) | 0/2,032 (0%) | 70/2,032 (3.4%) |
| Event | Xinzhijun |
|---|---|
| ALT increasedBlood and lymphatic system disorders | 25/2032 |
| AST increaesdBlood and lymphatic system disorders | 15/2032 |
| nauseaGastrointestinal disorders | 10/2032 |
| pyrexiaNervous system disorders | 10/2032 |
| diarrheaGastrointestinal disorders | 6/2032 |
| vomitingGastrointestinal disorders | 4/2032 |
| Age, Categorical(Participants) | Xinzhijun |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 1982 |
| >=65 years | 50 |
| Sex: Female, Male(Participants) | Xinzhijun |
|---|---|
| Female | 1250 |
| Male | 782 |
| Race (NIH/OMB)(Participants) | Xinzhijun |
|---|---|
| Chinese — American Indian or Alaska Native | 0 |
| Chinese — Asian | 2032 |
| Chinese — Native Hawaiian or Other Pacific Islander | 0 |
| Chinese — Black or African American | 0 |
| Chinese — White | 0 |
| Chinese — More than one race | 0 |
| Chinese — Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Xinzhijun |
|---|---|
| China | 2032 |
No study locations are listed for this record.
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Xiangbei Welman Pharmaceutical Co., Ltd