GonorrheaPhase 4CRO-SBTNCT04202068

A Study Evaluating Efficacy and Safety of CRO-SBT in the Treatment of Gonorrhea

A Phase 4 study testing Ceftriaxone sodium and Sulbactam Sodium for injection in people with Gonorrhea, 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

This is a phaseIV, multicenter, open-label，single arm study which will be performed to evaluate efficacy and safety of Ceftriaxone sodium and Sulbactam Sodium for injection for the treatment of uncomplicated urogenital infection caused by Neisseria gonorrhoeae in adolescent and adult subjects. Read more about this study

Who is it for?: Ages 6 to 80 years
Conditions the study is for: Gonorrhea
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: 113 participants
Where: No sites listed yet
Study dates: 3 Jul 2015to 30 May 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 6 to 80 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Subjects must be >=6 or ≦80 years of age at the time of signing the informed consent,both gender
Subjects having clinical suspicion of a urogenital gonococcal infection with or without gonococcal infection according to the laboratory test results of symptoms, physical symptoms, gonococcus smear, culture, etc.
Subjects having clinical suspicion of a gonococcal infection must have both of the following risk factors:once used three generations of cephalosporin invalid, and sensitive to this product (including gonorrhea urethritis, cervicitis, proctitis, pharyngitis).
Male and female subject must agree to use contraception (male condoms) during intercourse from the Baseline Visit through completion of the TOC Visit.

Who cannot join

Subject has a history of sensitivity to the study treatments, or components thereof, or a history of a drug (including erythromycin and any macrolide or ketolide drug) or other allergy that, in the opinion of the investigator or medical monitor, contraindicates his or her participation
Subject has received any cephalosporinl therapy for the treatment of a gonococcal infection
Pregnant or lactating women, or women Subject of childbearing age who were unwilling or unable to use acceptable methods of contraception throughout the study period.
Famale subject who were positive for pregnancy tests at the time of inclusion or before the start of study drug use.
Subject has risk of potentially serious drug interactions
Subject has major diseases such as cardiovascular disease, hepatorenal disease and mental disease, or other factors, the researcher should not participate in the study according to comprehensive judgment
Subject has a known history of alcohol or drug abuse
Subject has a known any complicated or systemic gonorrhea infection, such as pelvic inflammatory disease, arthritis, endocarditis

About this study

Official title: A Study Evaluating Efficacy and Safety of Ceftriaxone Sodium and Sulbactam Sodium for Injection in the Treatment of Uncomplicated Urogenital Gonorrhea

Read the detailed description

In this study, adults will be administered as one 3g IV dose at the study site,Children under 12 will be administered as one 75mg/kg IV dose . Approximately 100 subjects will be recruited to receive study treatment. The duration of the study will be approximately 14 days.

Conditions: Gonorrhea
Being tested: Ceftriaxone sodium and Sulbactam Sodium for injection
Medical subject headings: Gonorrhea

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 CRO-SBT
Ceftriaxone sodium and Sulbactam Sodium for injection is available as sterile powder for reconstitution.It will be administered as one 3g IV dose for adult or one 75mg/kg IV dose for children under 12.

Study groups in NCT04202068
Study group	Role	What they receive
Ceftriaxone sodium and Sulbactam Sodium for injection	Experimental	combinations of β-Lactamase inhibitors 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.

bacterial eradicatio
Number of subjects with culture-confirmed bacterial eradication of Neisseria gonorrhoeae from the urogenital site at the Test-of-Cure (TOC)
Measured: Up to Day 8

Secondary outcomes (2)

clinical cure
Number of subjects with disappearance of clinical symptoms and signs at the Test-of-Cure (TOC)
Measured: Up to Day 8
Comprehensive curative effect
Number of subjects with culture-confirmed bacterial eradication of Neisseria gonorrhoeae from the urogenital site and disappearance of clinical symptoms and signs
Measured: Up to Day 8

Timeline

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

3 Jul 201530 May 2016

First posted17 Dec 2019
Study start3 Jul 2015
Primary completion3 May 2016
Study completion30 May 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for GonorrheaStudies 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
Model description: Ceftriaxone sodium and Sulbactam Sodium for injection
Masking: None (open label)
Enrolment: 113 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04202068
Sponsor's protocol ID: GC0048-015
Acronym: CRO-SBT
Status last verified: Dec 2019
First submitted: 11 Dec 2019
Last updated: 17 Dec 2019
Results posted: No
Data monitoring committee: 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 Gonorrhea trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study Evaluating Efficacy and Safety of Ceftriaxone Sodium and Sulbactam Sodium for Injection in the Treatment of Uncomplicated Urogenital Gonorrhea
ClinicalTrials.gov ID: NCT04202068
Acronym / sponsor ID: CRO-SBT / GC0048-015
Conditions: Gonorrhea
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 113 participants (actual)
Lead sponsor: Xiangbei Welman Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
Study start: 3 Jul 2015 (actual)
Primary completion: 3 May 2016 (actual)
Study completion: 30 May 2016 (actual)
First posted: 17 Dec 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
Model description: Ceftriaxone sodium and Sulbactam Sodium for injection

Arm	Type	Receives
Ceftriaxone sodium and Sulbactam Sodium for injection	Experimental	Drug: Ceftriaxone sodium and Sulbactam Sodium for injectioncombinations of β-Lactamase inhibitors

Who may qualify

Ages: 6 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

Subjects must be >=6 or ≦80 years of age at the time of signing the informed consent,both gender
Subjects having clinical suspicion of a urogenital gonococcal infection with or without gonococcal infection according to the laboratory test results of symptoms, physical symptoms, gonococcus smear, culture, etc.
Subjects having clinical suspicion of a gonococcal infection must have both of the following risk factors:once used three generations of cephalosporin invalid, and sensitive to this product (including gonorrhea urethritis, cervicitis, proctitis, pharyngitis).
Male and female subject must agree to use contraception (male condoms) during intercourse from the Baseline Visit through completion of the TOC Visit.

Key exclusion criteria (8 listed)

Subject has a history of sensitivity to the study treatments, or components thereof, or a history of a drug (including erythromycin and any macrolide or ketolide drug) or other allergy that, in the opinion of the investigator or medical monitor, contraindicates his or her participation
Subject has received any cephalosporinl therapy for the treatment of a gonococcal infection
Pregnant or lactating women, or women Subject of childbearing age who were unwilling or unable to use acceptable methods of contraception throughout the study period.
Famale subject who were positive for pregnancy tests at the time of inclusion or before the start of study drug use.
Subject has risk of potentially serious drug interactions

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: CRO-SBTCeftriaxone sodium and Sulbactam Sodium for injection is available as sterile powder for reconstitution.It will be administered as one 3g IV dose for adult or one 75mg/kg IV dose for children under 12.	Drug	Ceftriaxone sodium and Sulbactam Sodium for injection

Primary outcome

bacterial eradicatio
Time frame: Up to Day 8
Number of subjects with culture-confirmed bacterial eradication of Neisseria gonorrhoeae from the urogenital site at the Test-of-Cure (TOC)

2 secondary outcomes

clinical cure
Time frame: Up to Day 8
Comprehensive curative effect
Time frame: Up to Day 8

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 17 Dec 2019.
Individual participant dataSharing planned: No

Related trials for Gonorrhea

Active, not recruitingPhase 4
Periodic Presumptive Treatment vs. doxyPEP for STI Control in Kenyan MSM
Gonorrhea Male, Chlamydia (Male)
Not yet recruiting
Pilot HIV Self-Testing And Self-collected STI Testing Strategy for Sex Worker Empowerment Study
HIV, Syphilis
Not yet recruitingPhase 3
A Clinical Study to Assess the Efficacy of Weekly Doxycycline Prophylaxis to Reduce Bacterial Sexually Transmitted Infections (STI) in Young African Women
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Not yet recruiting
Optimizing Antibiotic Prescription in STI Clinics Using Rapid POCT
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RecruitingPhase 4
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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.

pingyu P Zhou, Doctor principal investigator

Shanghai Dermatology Hospital

shunming S Xu, Doctor principal investigator

People's Hospital of Shanghai Pudong New Area

yanyue Tong, Doctor principal investigator

People's Hospital of Quzhou

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ceftriaxone sodium and Sulbactam Sodium for injection in people with Gonorrhea, 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 4 inclusion and 8 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 17 Dec 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?

bacterial eradicatio (time frame: Up to Day 8). 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 NCT04202068.

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 17 Dec 2019.