Respiratory Tract InfectionsPhase 4PIP-SBTNCT01897831
Piperacillin Sodium and Sulbactam Sodium for Injection (2:1) for Treatment of Respiratory and Urinary Tract Infection
A Phase 4 study testing xin te mie in people with Respiratory Tract Infections and Urinary Tract Infections, run by Xiangbei Welman Pharmaceutical Co., Ltd.
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 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?
- xin te mie
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- Aug 2011to Nov 2015
- 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 years and older
- 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.
About this study
Official title: A Open Multi-center Clinical Study on Piperacillin Sodium and Sulbactam Sodium for Injection (2:1) for Treatment of Respiratory and Urinary Tract Infection
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 under the widely used in clinical conditions.
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 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 Piperacillin in the treatment-resistant pathogen infections.
- Being tested
- xin te mie
- Keywords
- Piperacillin Sodium and 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.
xin te mieDrug
Also called te mie jun, xin ke jun
durg:Piperacillin Sodium and Sulbactam Sodium for Injection(2:1) 1.5-3.0g,iv,bid for 7-14 days Serious infections:6.0-12.0g,iv,tid for 7-14 days
| Study group | Role | What they receive |
|---|---|---|
| xin te mie | Experimental | 1.5-3.0g,iv,bid or tid for 7-14 days Receives: Drug: xin te mie |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall effect
end of treatment of bacteriological efficacy(bacterial clearance)
The fore-and-aft changes of clinical symptoms and signs after discontinuation of drugs
Measured: two year
Secondary outcomes (1)
Number of participants with Adverse Events
the incidence(%)of allergies, skin rashes, shock,death, etc.
Measured: two year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study startAug 2011
- Primary completionAug 2015 (estimated)
- Study completionNov 2015 (estimated)
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 (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangbei Welman Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- changqing cq li, doctor, Study director, Chongqing Red Cross Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01897831
- Sponsor's protocol ID
- 2002 H L 0153
- Acronym
- PIP-SBT
- Status last verified
- Sep 2012
- First submitted
- 3 Jun 2013
- Last updated
- 12 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Open Multi-center Clinical Study on Piperacillin Sodium and Sulbactam Sodium for Injection (2:1) for Treatment of Respiratory and Urinary Tract Infection
- ClinicalTrials.gov ID
- NCT01897831
- Acronym / sponsor ID
- PIP-SBT / 2002 H L 0153
- Keywords
- Piperacillin Sodium and sulbactam sodium, Phase IV clinical studies, Respiratory and urinary tract infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Xiangbei Welman Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 12 Jul 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.
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 under the widely used in clinical conditions.
Detailed description
Piperacillin 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 Piperacillin in the treatment-resistant pathogen infections.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| xin te mie | Experimental | Drug: xin te mie1.5-3.0g,iv,bid or tid for 7-14 days |
Who may qualify
- Ages
- 18 years and older
- 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 |
|---|---|---|
| xin te mieAlso: te mie jun, xin ke jundurg:Piperacillin Sodium and Sulbactam Sodium for Injection(2:1) 1.5-3.0g,iv,bid for 7-14 days Serious infections:6.0-12.0g,iv,tid for 7-14 days | Drug | xin te mie |
Primary outcome
overall effect
Time frame: two year
end of treatment of bacteriological efficacy(bacterial clearance) The fore-and-aft changes of clinical symptoms and signs after discontinuation of drugs
1 secondary outcome
Number of participants with Adverse Events
Time frame: two year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2013.
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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 cq li, doctor study director
Chongqing Red Cross Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing xin te mie in people with 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: status not confirmed, as of the sponsor's last update on 12 Jul 2013. 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.
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?
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?
overall effect (time frame: two year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jul 2013; AzTrials last refreshed its copy on 7 Nov 2026.