N/A
N=2,032
Study on Cefotaxime and Sulbactam Sodium for Injection (2:1) for Treatment of Respiratory and Urinary Tract Infection
Respiratory Tract Infections · Urinary Tract Infections
Bottom Line
View on ClinicalTrials.gov: NCT01426191 ↗Enrolled (actual)
2,032
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Number of Participants With Adverse Events — 10; 4; 6; 10 Participants — p=0.05
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- xinzhijun (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Xiangbei Welman Pharmaceutical Co., Ltd
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
10; 4; 6; 10; 25; 15 | 0.05 |
| SECONDARY Clinical Effect |
2022; 10 | 0.01 sig |
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.
Eligibility Criteria
Inclusion Criteria
- patients who qualify for moderate and severe acute respiratory or urinary tract bacterial infection of acute bacterial infections need for systemic antibiotic therapy.
- Age>18 years old, Gender: both
- Women of childbearing age were to be negative pregnancy test and agree to take contraceptive measures during the trial;
- patients were volunteers and signed informed consent form;
- patients did not participate in other clinical trials.
Exclusion Criteria
- Patients were hypersusceptibility to the test drug or other penicillins ,β-lactamase inhibitor
- Pregnant and Lactating women
- Patients have severe liver, kidney,cardiovascular,cerebrovascular,endocrine and hematopoietic system of primary diseases and that of immunodeficiency,advanced cancer or mental illness.
- Patients who were complicated by other diseases and thought to affect efficacy evaluations or poor compliance.
Data sourced from ClinicalTrials.gov (NCT01426191). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.