Respiratory Tract InfectionsPhase 2CAZ-SBTNCT01601093

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

A Phase 2 study testing High dose, Low dose and Cefoperazone and Sulbactam Sodium (CFP/SUB) in people with Respiratory Tract Infections and Urinary Tract Infections, run by Xiangbei Welman Pharmaceutical Co., Ltd at 1 site in China.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record

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Trial summary

In the proposed study, the investigators plan to evaluate the efficacy and safety of Ceftazidime Sodium and Sulbactam Sodium for Injection(2:1) for the treatment of respiratory and urinary tract acute bacterial infection. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Respiratory Tract Infections, Urinary Tract Infections
What is being tested?: High dose, Low dose and Cefoperazone and Sulbactam Sodium (CFP/SUB)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 288 participants
Where: 1 siteChina
Study dates: Nov 2011to 15 Dec 2022
Phase: Phase 2
Are there results?: None posted in the registry

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 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

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.
Hospital patients or good compliance clinic patients, who were more than 18 years old and less than 70 years old, Gender: both.
Patients who do not take other antibiotic medications before screening period.
Patients who have no severe liver, kidney and hematopoietic system of diseases (Both AST and ALT are less than 1.5 times of the upper limit of normal and Cr is in normal range)
Pathogenic bacteria was resistant to ceftazidime and sensitive to both of test drugs and contrast drugs.
Women of childbearing was to be negative pregnancy test and agree to take contraceptive measures during the trial.
Patients were volunteers and signed informed consent from.

Who cannot join

Patients were hypersusceptibility to the test drug or other penicillins ,β-lactamase inhibitor
Pathogenic bacteria was sensitive to ceftazidime or resistant to ceftazidime,test drugs and control drugs.
Patients who need to take other antibiotic medicine because of concurrent infection.
Patients who took medicine which affected efficacy evaluations and safety evaluations such as aspirin, indomethacin, phenylbutazone, sulfanilamide, disulfiram and probenecid in the trial.
Patients who took risks of severe drug interactions because of drug combination.
Patients who were complicated by other diseases and thought to affect efficacy evaluations or poor compliance.

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Pregnant and Lactating women
Drug addicts and alcoholics.
Patients who once was selected in this trial.
Patients who participated in other clinical trials in the past three months.

Trial locations and contacts

1 site in 1 country.

China1 site

the First Affiliated Hospital With Medical University
Nanjing, Jiangsu

Other trials in China

About this study

Official title: Phase Ⅱ Study on Ceftazidime Sodium and Sulbactam Sodium for Injection(2:1) for Treatment of Respiratory and Urinary System Infection

Read the detailed description

Ceftazidime is a third-generation cephalosporins. Ceftazidime sodium and sulbactam sodium for injection (2:1)plays a therapeutic role by the former inhibiting bacterial cell wall synthesis，the latter making irreversible competitive inhibition of β-lactamase.The antimicrobial effect of ceftazidime can be enhanced by the two combined. The compound specifically aims to the mechanism of bacterial resistance, extending the life of ceftazidime in the treatment-resistant pathogen infections.

Conditions: Respiratory Tract Infections, Urinary Tract Infections
Being tested: High dose, Low dose, Cefoperazone and Sulbactam Sodium (CFP/SUB)
Keywords: Respiratory and urinary tract infections, Ceftazidime and Sulbactam Sodium for Injection (2:1), Phase Ⅱ
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.

High doseDrug
Also called high dose group
Ceftazidime 3g, iv, bid and Sulbactam Sodium 1.5g, iv, bid for 5-14days.
Low doseDrug
Ceftazidime 2g, iv, bid and Sulbactam Sodium 1g, iv, bid for 5-14days.
Cefoperazone and Sulbactam Sodium (CFP/SUB)Drug
Also called CFP/SUB(2:1)
Cefoperazone 2g, iv, bid and Sulbactam Sodium 1g, iv, bid for 5-14days.

Study groups in NCT01601093
Study group	Role	What they receive
High dose	Experimental	Ceftazidime 3g Receives: Drug: High dose
Low dose	Experimental	Ceftazidime 2g Receives: Drug: Low dose
CFP/SUB	Active comparator	Cefoperazone and sulbactam sodium for injection(2:1) Receives: Drug: Cefoperazone and Sulbactam Sodium (CFP/SUB)

What is being measured

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

The rate of bacterial clearance
end of treatment of bacteriological efficacy(bactercial clearance) The fore-and-aft changes of clinical symptoms and signs after discontinuation of durgs
Measured: two years

Secondary outcomes (1)

Number of participants with Adverse Events
the incidence(%)of allergies, skin rashes, shock,death, etc.
Measured: two years

Timeline

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

Nov 201115 Dec 2022

First posted17 May 2012 (estimated)
Study startNov 2011
Primary completion15 Aug 2022 (estimated)
Study completion15 Dec 2022 (estimated)

Why it stopped: other project got priority

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind
Who is masked: Participant
Enrolment: 288 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01601093
Sponsor's protocol ID: 2008L03354
Acronym: CAZ-SBT
Status last verified: Jul 2019
First submitted: 27 Apr 2012
Last updated: 5 Jul 2019
Results posted: No
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?

See locations

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All Respiratory Tract Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase Ⅱ Study on Ceftazidime Sodium and Sulbactam Sodium for Injection(2:1) for Treatment of Respiratory and Urinary System Infection
ClinicalTrials.gov ID: NCT01601093
Acronym / sponsor ID: CAZ-SBT / 2008L03354
Conditions: Respiratory Tract Infections, Urinary Tract Infections
Keywords: Respiratory and urinary tract infections, Ceftazidime and Sulbactam Sodium for Injection (2:1), Phase Ⅱ
Phase: Phase 2
Study type: Interventional
Recruitment status: SuspendedReason stopped: other project got priority
Enrolment: 288 participants (estimated)
Lead sponsor: Xiangbei Welman Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
Study start: Nov 2011
Primary completion: 15 Aug 2022 (estimated)
Study completion: 15 Dec 2022 (estimated)
First posted: 17 May 2012 (estimated)
Results: Not posted in the source record

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

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
High dose	Experimental	Drug: High doseCeftazidime 3g
Low dose	Experimental	Drug: Low doseCeftazidime 2g
CFP/SUB	Active comparator	Drug: Cefoperazone and Sulbactam Sodium (CFP/SUB)Cefoperazone and sulbactam sodium for injection(2:1)

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Patients who qualify for moderate and severe acute respiratory or urinary tract bacterial infection of acute bacterial infections need for systemic antibiotic therapy.
Hospital patients or good compliance clinic patients, who were more than 18 years old and less than 70 years old, Gender: both.
Patients who do not take other antibiotic medications before screening period.
Patients who have no severe liver, kidney and hematopoietic system of diseases (Both AST and ALT are less than 1.5 times of the upper limit of normal and Cr is in normal range)
Pathogenic bacteria was resistant to ceftazidime and sensitive to both of test drugs and contrast drugs.

Key exclusion criteria (10 listed)

Patients were hypersusceptibility to the test drug or other penicillins ,β-lactamase inhibitor
Pathogenic bacteria was sensitive to ceftazidime or resistant to ceftazidime,test drugs and control drugs.
Patients who need to take other antibiotic medicine because of concurrent infection.
Patients who took medicine which affected efficacy evaluations and safety evaluations such as aspirin, indomethacin, phenylbutazone, sulfanilamide, disulfiram and probenecid in the trial.
Patients who took risks of severe drug interactions because of drug combination.

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
High doseAlso: high dose groupCeftazidime 3g, iv, bid and Sulbactam Sodium 1.5g, iv, bid for 5-14days.	Drug	High dose
Low doseCeftazidime 2g, iv, bid and Sulbactam Sodium 1g, iv, bid for 5-14days.	Drug	Low dose
Cefoperazone and Sulbactam Sodium (CFP/SUB)Also: CFP/SUB(2:1)Cefoperazone 2g, iv, bid and Sulbactam Sodium 1g, iv, bid for 5-14days.	Drug	CFP/SUB

Primary outcome

The rate of bacterial clearance
Time frame: two years
end of treatment of bacteriological efficacy(bactercial clearance) The fore-and-aft changes of clinical symptoms and signs after discontinuation of durgs

1 secondary outcome

Number of participants with Adverse Events
Time frame: two years

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.

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.

hong wh wang, doctor principal investigator

The first affliated hospital with Nanjing Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 10 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: paused, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

The rate of bacterial clearance (time frame: two years). 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 NCT01601093.

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 5 Jul 2019.