Respiratory Tract InfectionsPhase 4CRO-SBTNCT04066621

PHase IV Clinical Trial of Ceftriaxone Sodium and Sulbactam Sodium for Injection (CRO-SBT)

A Phase 4 study testing Ceftriaxone Sodium and Sulbactam Sodium for Injection in people with Respiratory Tract Infections and Urinary Tract Infections in Children, 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

To evaluate the safety and efficacy of treatment of children with acute bacterial infection disease with Ceftriaxone Sodium and Sulbactam Sodium for Injection in the condition of widely used, and provide the basis of adjusting the dosage regimen for children in particular. Read more about this study

Who is it for?: Ages 6 to 14 years
Conditions the study is for: Respiratory Tract Infections, Urinary Tract Infections in Children
What is being tested?: Ceftriaxone Sodium and Sulbactam Sodium for Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: No sites listed yet
Study dates: 28 Apr 2015to 27 May 2017
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 6 to 14 years
All sexes
No healthy volunteers
Child

Who may be able to join

Male or female children ages≥6 years to< 14 years.
Weight≥18kg who in hospital or outpatients with good compliance;
The subjects were diagnosed as respiratory infection, urinary tract infection or other infection caused by the compound sensitive bacteria after clinical symptoms and signs laboratory examination and auxiliary examination according to the clinically recognized diagnostic criteria, and should be treated with systemic antibiotics;
Subjects had not used effective antimicrobial agents before screening, or had used antimicrobial agents but the efficacy was not obvious;
No severe liver and kidney cardiovascular and hematopoietic diseases were found in the subjects (AST and ALT were not more than 1.5 times of the upper limit of normal value,Cr was within the normal range);
Subject guardian informed consent and/or subject's own informed consent subject volunteers to participate in this study and has signed the subject's informed consent.

Who cannot join

History of hypersensitivity reactions to carbapenems, cephalosporins, penicillin, other β-lactam antibiotics;
Patients with specific infections who require treatment with other antimicrobial agents;
Use of penicillin roxithromycin vitamin B vitamin C and other drugs may interfere with the efficacy or safety evaluation of drugs at the same time;
Patients at risk of serious drug interactions due to combination of medications;
Patients who have other diseases and thought to affect efficacy evaluations or be poor compliance;
Attended clinical trial in three monthes.

About this study

Official title: Efficacy and Safety of CRO-SBT Performed in Children With Acute Bacterial Infection

Read the detailed description

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

Conditions: Respiratory Tract Infections, Urinary Tract Infections in Children
Being tested: Ceftriaxone Sodium and Sulbactam Sodium for Injection
Medical subject headings: Respiratory Tract Infections

What participants receive

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

Ceftriaxone Sodium and Sulbactam Sodium for InjectionDrug
Also called weipufen
daily dose was 75 mg/kg by weight, 1-2 times ivgtt per day, 4 to 14 days

Study groups in NCT04066621
Study group	Role	What they receive
CRO-SBT	Experimental	Ceftriaxone Sodium and Sulbactam Sodium for Injection(2:1) Receives: Drug: Ceftriaxone Sodium and Sulbactam Sodium for Injection

What is being measured

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

The cure rate of patients
Clinically effective/Clinically ineffective
Measured: Seven days after treatment

Secondary outcomes (1)

bacterial clearance rate
end of treatment of bacteriological efficacy (bacterial clearance rate)
Measured: 48 hours after treatment

Timeline

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

28 Apr 201527 May 2017

First posted26 Aug 2019
Study start28 Apr 2015
Primary completion11 Jun 2016
Study completion27 May 2017

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: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04066621
Sponsor's protocol ID: LENVOCRO (2012)CSSSI-0.4
Acronym: CRO-SBT
Status last verified: Aug 2019
First submitted: 22 Aug 2019
Last updated: 28 Aug 2019
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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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All Respiratory Tract Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of CRO-SBT Performed in Children With Acute Bacterial Infection
ClinicalTrials.gov ID: NCT04066621
Acronym / sponsor ID: CRO-SBT / LENVOCRO (2012)CSSSI-0.4
Conditions: Respiratory Tract Infections, Urinary Tract Infections in Children
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Xiangbei Welman Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
Study start: 28 Apr 2015 (actual)
Primary completion: 11 Jun 2016 (actual)
Study completion: 27 May 2017 (actual)
First posted: 26 Aug 2019 (actual)
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
CRO-SBT	Experimental	Drug: Ceftriaxone Sodium and Sulbactam Sodium for InjectionCeftriaxone Sodium and Sulbactam Sodium for Injection(2:1)

Who may qualify

Ages: 6 to 14 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (6 listed)

Male or female children ages≥6 years to< 14 years.
Weight≥18kg who in hospital or outpatients with good compliance;
The subjects were diagnosed as respiratory infection, urinary tract infection or other infection caused by the compound sensitive bacteria after clinical symptoms and signs laboratory examination and auxiliary examination according to the clinically recognized diagnostic criteria, and should be treated with systemic antibiotics;
Subjects had not used effective antimicrobial agents before screening, or had used antimicrobial agents but the efficacy was not obvious;
No severe liver and kidney cardiovascular and hematopoietic diseases were found in the subjects (AST and ALT were not more than 1.5 times of the upper limit of normal value,Cr was within the normal range);

Key exclusion criteria (6 listed)

History of hypersensitivity reactions to carbapenems, cephalosporins, penicillin, other β-lactam antibiotics;
Patients with specific infections who require treatment with other antimicrobial agents;
Use of penicillin roxithromycin vitamin B vitamin C and other drugs may interfere with the efficacy or safety evaluation of drugs at the same time;
Patients at risk of serious drug interactions due to combination of medications;
Patients who have other diseases and thought to affect efficacy evaluations or be 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
Ceftriaxone Sodium and Sulbactam Sodium for InjectionAlso: weipufendaily dose was 75 mg/kg by weight, 1-2 times ivgtt per day, 4 to 14 days	Drug	CRO-SBT

Primary outcome

The cure rate of patients
Time frame: Seven days after treatment
Clinically effective/Clinically ineffective

1 secondary outcome

bacterial clearance rate
Time frame: 48 hours after treatment

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 28 Aug 2019.
Individual participant dataSharing planned: No

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)
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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
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A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
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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.

yuhua hu, Doctor principal investigator

The First Affiliated Hospital with Nanjing Medical University

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 6 inclusion and 6 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 28 Aug 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.

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 cure rate of patients (time frame: Seven days after treatment). 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 NCT04066621.

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 28 Aug 2019.