Respiratory Tract InfectionsPhase 4PIP-SBTNCT01760109

Piperacillin Sodium and Sulbactam Sodium for Injection(2:1) for Treatment of Respiratory and Urinary System Infection

A Phase 4 study testing Piperacillin Sodium and Sulbactam Sodium in people with Respiratory Tract Infections and Urinary Tract Infections, run by Xiangbei Welman Pharmaceutical Co., Ltd at 1 site in China.

Completed

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

Official record

Search all trials

Trial summary

In the proposed study, the investigators plan to evaluate the efficacy and safety of Piperacillin 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?: Piperacillin Sodium and Sulbactam Sodium
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,000 participants
Where: 1 siteChina
Study dates: Jul 2011to Jun 2016
Phase: Phase 4
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.
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.

Trial locations and contacts

1 site in 1 country.

China1 site

Chongqing Red Cross hospital
Chongqing, 400020

Other trials in China

About this study

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

Read the detailed description

Piperacillin 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 Piperacillin can be enhanced by the two combined. The compound specifically aims to the mechanism of bacterial resistance, extending the life of Piperacillin in the treatment-resistant pathogen infections.

Conditions: Respiratory Tract Infections, Urinary Tract Infections
Being tested: Piperacillin Sodium and Sulbactam Sodium
Keywords: Respiratory and urinary tract infections, Piperacillin Sodium and Sulbactam Sodium for Injection (2:1), Phase IV
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.

Piperacillin Sodium and Sulbactam SodiumDrug
Also called xin te mie, te mie jun, xin ke jun
1.5-3.0g,iv,bid 7-14 days serious infections 6.0-12.0g,iv,tid for 7-14 days

Study groups in NCT01760109
Study group	Role	What they receive
Piperacillin Sodium and Sulbactam Sodium	Experimental	Drug:xintemie 1.5-3.0g,iv,bid 7-14 days serious infections 6.0-12.0g,iv,tid for 7-14 days Receives: Drug: Piperacillin Sodium and Sulbactam Sodium

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.

Jul 2011Jun 2016

First posted3 Jan 2013 (estimated)
Study startJul 2011
Primary completionJun 2016
Study completionJun 2016

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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 2,000 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01760109
Sponsor's protocol ID: 2002HL0153
Acronym: PIP-SBT
Status last verified: Jul 2019
First submitted: 19 Dec 2012
Last updated: 8 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

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

All Respiratory Tract Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase IV Study on Piperacillin Sodium and Sulbactam Sodium for Injection(2:1) for Treatment of Respiratory and Urinary System Infection
ClinicalTrials.gov ID: NCT01760109
Acronym / sponsor ID: PIP-SBT / 2002HL0153
Conditions: Respiratory Tract Infections, Urinary Tract Infections
Keywords: Respiratory and urinary tract infections, Piperacillin Sodium and Sulbactam Sodium for Injection (2:1), Phase IV
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,000 participants (actual)
Lead sponsor: Xiangbei Welman Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
Study start: Jul 2011
Primary completion: Jun 2016 (actual)
Study completion: Jun 2016 (actual)
First posted: 3 Jan 2013 (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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Piperacillin Sodium and Sulbactam Sodium	Experimental	Drug: Piperacillin Sodium and Sulbactam SodiumDrug:xintemie 1.5-3.0g,iv,bid 7-14 days serious infections 6.0-12.0g,iv,tid for 7-14 days

Who may qualify

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

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
Piperacillin Sodium and Sulbactam SodiumAlso: xin te mie, te mie jun, xin ke jun1.5-3.0g,iv,bid 7-14 days serious infections 6.0-12.0g,iv,tid for 7-14 days	Drug	Piperacillin Sodium and Sulbactam Sodium

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

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 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.

Changqing Li, doctor principal investigator

Chongqing Red Cross Hospital

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 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 8 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 NCT01760109.

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 8 Jul 2019.