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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ceftriaxone sodium and Sulbactam Sodium for injection | Experimental | combinations of β-Lactamase inhibitors |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ceftriaxone sodium and Sulbactam Sodium for injection | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| bacterial eradicatio | Number of subjects with culture-confirmed bacterial eradication of Neisseria gonorrhoeae from the urogenital site at the Test-of-Cure (TOC) | Up to Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| clinical cure | Number of subjects with disappearance of clinical symptoms and signs at the Test-of-Cure (TOC) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| pingyu P Zhou, Doctor | Shanghai Dermatology Hospital | Principal Investigator |
| shunming S Xu, Doctor | People's Hospital of Shanghai Pudong New Area | Principal Investigator |
| yanyue Tong, Doctor | People's Hospital of Quzhou | Principal Investigator |
| zhehu Jin, Doctor | The Affiliated Hospital of Yanbian University | Principal Investigator |
| bo Cheng, Doctor | First Affiliated Hospital of Fujian Medical University | Principal Investigator |
| wuqing W Wang, Doctor | The Central Hospital of Shanghai Minhang District | Principal Investigator |
| ping Wang, Doctor | The Third People's Hospital of Hangzhou | Principal Investigator |
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| ID | Term |
|---|---|
| D006069 | Gonorrhea |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D002443 | Ceftriaxone |
| D013407 | Sulbactam |
| D007267 | Injections |
| ID | Term |
|---|---|
| D002439 | Cefotaxime |
| D002505 | Cephacetrile |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
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Ceftriaxone sodium and Sulbactam Sodium for injection
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|
| Up to Day 8 |
| D007239 | Infections |
| D015231 | Sexually Transmitted Diseases, Bacterial |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007769 |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010406 | Penicillins |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |