Respiratory Tract InfectionsSWSBNCT01426191

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

An observational study of Respiratory Tract Infections and Urinary Tract Infections, run by Xiangbei Welman Pharmaceutical Co., Ltd.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Respiratory Tract Infections, Urinary Tract Infections
What is being tested?: xinzhijun
Type of treatment: Injection or infusion
How many people: 2,032 participants
Where: No sites listed yet
Study dates: Aug 2011to Dec 2016
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: hospitalized patients or outpatients

Who may be able to join

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.

Who cannot join

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.

About this study

Official title: A Open Multi-center Clinical Study on Cefotaxime Sodium and Sulbactam Sodium for Injection(2:1) for Treatment of Respiratory and Urinary Tract Infection

Read the detailed description

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.

Conditions: Respiratory Tract Infections, Urinary Tract Infections
Being tested: xinzhijun
Keywords: Cefotaxime sulbactam sodium, Phase IV clinical studies, Respiratory and urinary tract infections
Medical subject headings: Respiratory Tract Infections, Urinary Tract Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

xinzhijunDrug
Also called Experimental, shumate
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

Study groups in NCT01426191
Study group	Role	What they receive
xinzhijun		1.5-3.0g,iv,bid or tid for 5-12 days Receives: Drug: xinzhijun

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Events
the incidence(%)of allergies, skin rashes, shock,death, etc.
Measured: day0-day22-28

Secondary outcomes (1)

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).
Measured: at weeks 4,day22-28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2011Dec 2016

First posted31 Aug 2011 (estimated)
Study startAug 2011
Primary completionApr 2015
Study completionDec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Respiratory Tract InfectionsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 2,032 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01426191
Sponsor's protocol ID: 20090095
Acronym: SWSB
Status last verified: Sep 2019
First submitted: 23 Aug 2011
Last updated: 4 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Enrolling by invitation
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All Respiratory Tract Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Open Multi-center Clinical Study on Cefotaxime Sodium and Sulbactam Sodium for Injection(2:1) for Treatment of Respiratory and Urinary Tract Infection
ClinicalTrials.gov ID: NCT01426191
Acronym / sponsor ID: SWSB / 20090095
Conditions: Respiratory Tract Infections, Urinary Tract Infections
Keywords: Cefotaxime sulbactam sodium, Phase IV clinical studies, Respiratory and urinary tract infections
Study type: Observational
Recruitment status: Completed
Enrolment: 2,032 participants (actual)
Lead sponsor: Xiangbei Welman Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
Study start: Aug 2011
Primary completion: Apr 2015 (actual)
Study completion: Dec 2016 (actual)
First posted: 31 Aug 2011 (estimated)
Results: Posted 4 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
xinzhijun	–	Drug: xinzhijun1.5-3.0g,iv,bid or tid for 5-12 days

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: hospitalized patients or outpatients

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
xinzhijunAlso: Experimental, shumatedurg: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	Drug	xinzhijun

Primary outcome

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

1 secondary outcome

Clinical Effect
Time frame: at weeks 4,day22-28

Results and safety

Results posted to the registry on 4 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Xinzhijun	2,032	2,032

Primary outcome: Number of Participants With Adverse Events

Time frame: day0-day22-28. Count of participants. Unit: Participants

Measure	Xinzhijun n = 2032
nausea	10
vomiting	4
diarrhea	6
Pyrexia	10
ALT increased	25
AST increased	15
no	1962

Xinzhijun: p = 0.05, Fisher Exact

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Xinzhijun	0 of 2,032 (0%)	70 of 2,032 (3.4%)	0 of 2,032

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Respiratory Tract Infections

Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
VIRal Pulmonary Infections in Older AGE
Viral Pulmonary Infections
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

lanjuan lj li, docter principal investigator

Zhejiang University

changqing cq li, doctor study director

Chongqing Red Cross Hospital

Questions about this trial

What is this clinical trial studying?

An observational study of Respiratory Tract Infections and Urinary Tract Infections, run by Xiangbei Welman Pharmaceutical Co., Ltd.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (time frame: day0-day22-28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01426191.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2019; AzTrials last refreshed its copy on 6 Nov 2026.