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other project got priority
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In the proposed study, the investigators plan to evaluate the efficacy and safety of Ceftazidime Sodium and Sulbactam Sodium for Injection(2:1) for the treatment of respiratory and urinary tract acute bacterial infection.
Ceftazidime is a third-generation cephalosporins. Ceftazidime 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 ceftazidime can be enhanced by the two combined. The compound specifically aims to the mechanism of bacterial resistance, extending the life of ceftazidime in the treatment-resistant pathogen infections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dose | Experimental | Ceftazidime 3g |
|
| Low dose | Experimental | Ceftazidime 2g |
|
| CFP/SUB | Active Comparator | Cefoperazone and sulbactam sodium for injection(2:1) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High dose | Drug | Ceftazidime 3g, iv, bid and Sulbactam Sodium 1.5g, iv, bid for 5-14days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | two years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse Events | the incidence(%)of allergies, skin rashes, shock,death, etc. | two years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| hong wh wang, doctor | The first affliated hospital with Nanjing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital With Medical University | Nanjing | Jiangsu | China |
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| Low dose | Drug | Ceftazidime 2g, iv, bid and Sulbactam Sodium 1g, iv, bid for 5-14days. |
|
| Cefoperazone and Sulbactam Sodium (CFP/SUB) | Drug | Cefoperazone 2g, iv, bid and Sulbactam Sodium 1g, iv, bid for 5-14days. |
|
|
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D044382 | Population Groups |
| D003276 | Contraceptives, Oral |
| D002438 | Cefoperazone |
| D013407 | Sulbactam |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
| D003271 | Contraceptive Agents, Female |
| D003270 | Contraceptive Agents |
| D012102 | Reproductive Control Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045506 | Therapeutic Uses |
| D002435 | Cefamandole |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| 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 |
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