Trial Outcomes & Findings for Study on Cefotaxime and Sulbactam Sodium for Injection (2:1) for Treatment of Respiratory and Urinary Tract Infection (NCT NCT01426191)

NCT ID: NCT01426191

Last Updated: 2019-10-04

Results Overview

the incidence(%)of allergies, skin rashes, shock,death, etc.

• Recruitment status: COMPLETED
• Target enrollment: 2032 participants
• Primary outcome timeframe: day0-day22-28
• Results posted on: 2019-10-04

Participant Flow

post market

Third-generation cephalosporin resistant

Participant milestones

Measure	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
Overall Study STARTED	2032
Overall Study COMPLETED	2032
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study on Cefotaxime and Sulbactam Sodium for Injection (2:1) for Treatment of Respiratory and Urinary Tract Infection

Baseline characteristics by cohort

Measure	Xinzhijun n=2032 Participants xinzhijun:third generation beta-lactam cephalosporin and beta lactamase inhibitors (BLIs)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1982 Participants n=5 Participants
Age, Categorical >=65 years	50 Participants n=5 Participants
Sex: Female, Male Female	1250 Participants n=5 Participants
Sex: Female, Male Male	782 Participants n=5 Participants
Race (NIH/OMB) Chinese · American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Chinese · Asian	2032 Participants n=5 Participants
Race (NIH/OMB) Chinese · More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Chinese · Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Chinese · Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) Chinese · White	0 Participants n=5 Participants
Race (NIH/OMB) Chinese · Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment China	2032 participants n=5 Participants

PRIMARY outcome

Timeframe: day0-day22-28

the incidence(%)of allergies, skin rashes, shock,death, etc.

Outcome measures

Measure	Xinzhijun n=2032 Participants 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
Number of Participants With Adverse Events nausea	10 Participants
Number of Participants With Adverse Events vomiting	4 Participants
Number of Participants With Adverse Events diarrhea	6 Participants
Number of Participants With Adverse Events Pyrexia	10 Participants
Number of Participants With Adverse Events ALT increased	25 Participants
Number of Participants With Adverse Events AST increased	15 Participants
Number of Participants With Adverse Events no	1962 Participants

SECONDARY outcome

Timeframe: at weeks 4,day22-28

Population: included all the participants

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).

Outcome measures

Measure	Xinzhijun n=2032 Participants 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
Clinical Effect cure	2022 Participants
Clinical Effect failure	10 Participants

Adverse Events

Xinzhijun

Serious events: 0 serious events

Other events: 70 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Xinzhijun n=2032 participants at risk 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
Gastrointestinal disorders nausea	0.49% 10/2032 • Number of events 10
Gastrointestinal disorders vomiting	0.20% 4/2032 • Number of events 4
Gastrointestinal disorders diarrhea	0.30% 6/2032 • Number of events 7
Nervous system disorders pyrexia	0.49% 10/2032 • Number of events 11
Blood and lymphatic system disorders ALT increased	1.2% 25/2032 • Number of events 25
Blood and lymphatic system disorders AST increaesd	0.74% 15/2032 • Number of events 15

Additional Information

Directer of clinical trials

xiangbei welman pharmacuticol CO.,LTD

Phone: 020-38868707

Email: gap@welman.com.cn

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60