Trial · NCT01426191

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

NCT01426191, Completed, Xiangbei Welman Pharmaceutical Co., Ltd; results first posted 2019-10-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study on Cefotaxime and Sulbactam Sodium for Injection (2:1) for Treatment of Respiratory and Urinary Tract Infection. Trials, record NCT01426191. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01426191

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study on Cefotaxime and Sulbactam Sodium for Injection (2:1) for Treatment of Respiratory and Urinary Tract Infection
NCT number: NCT01426191
Status: Completed
Enrollment: 2,032 participants, actual
Lead sponsor: Xiangbei Welman Pharmaceutical Co., Ltd
Conditions: Respiratory Tract Infections, Urinary Tract Infections
Interventions: xinzhijun
First posted: 2011-08-31
Last updated: 2019-10-04
Results first posted: 2019-10-04

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Adverse Events	day0-day22-28	the incidence(%)of allergies, skin rashes, shock,death, etc.
Secondary	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).

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Adverse Events	day0-day22-28		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Clinical Effect	at weeks 4,day22-28	included all the participants	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group9

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Participants With Adverse Events	Xinzhijun	nausea	10	Participants
Number of Participants With Adverse Events	Xinzhijun	vomiting	4	Participants
Number of Participants With Adverse Events	Xinzhijun	diarrhea	6	Participants
Number of Participants With Adverse Events	Xinzhijun	Pyrexia	10	Participants
Number of Participants With Adverse Events	Xinzhijun	ALT increased	25	Participants
Number of Participants With Adverse Events	Xinzhijun	AST increased	15	Participants
Number of Participants With Adverse Events	Xinzhijun	no	1962	Participants
Clinical Effect	Xinzhijun	cure	2022	Participants
Clinical Effect	Xinzhijun	failure	10	Participants

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Xinzhijun	2,032
Overall Study	COMPLETED	Xinzhijun	2,032
Overall Study	NOT COMPLETED	Xinzhijun	0

Source ClinicalTrials.gov

Adverse events6

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	nausea	Gastrointestinal disorders	Xinzhijun	10	2,032	10
other	vomiting	Gastrointestinal disorders	Xinzhijun	4	2,032	4
other	diarrhea	Gastrointestinal disorders	Xinzhijun	6	2,032	7
other	pyrexia	Nervous system disorders	Xinzhijun	10	2,032	11
other	ALT increased	Blood and lymphatic system disorders	Xinzhijun	25	2,032	25
other	AST increaesd	Blood and lymphatic system disorders	Xinzhijun	15	2,032	15

Source ClinicalTrials.gov

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Xinzhijun	0	2,032
Total, other adverse events	Xinzhijun	70	2,032
Total, serious adverse events	Xinzhijun	0	2,032

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01426191

GET https://conductscience.org/api/trials/v1/NCT01426191/registered

API reference For AI assistants