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It is planned to compare the efficacy and safety of cefdinir and cefdinir/clavulanic acide treatments in acute exacerbation of chronic bronchitis (AECB) and community-acquired pneumoniae (CAP) patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cefdinir/clavulanic acide 300/125 mg Film Coated Tablets | Experimental |
| |
| Cefdinir 300 mg Capsules | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cefdinir/clavulanic acide 300/125 mg film-coated tablets | Combination Product | Cefdinir is already an approved drug. In this study, developed cefdinir/clavulanic acide combination will be compared against to cefdinir alone. |
| Measure | Description | Time Frame |
|---|---|---|
| The comparison of clinical success rates according to laboratory parameters | 7-10 days |
| Measure | Description | Time Frame |
|---|---|---|
| The comparison of remission or relief of inflammation according to laboratory parameters | 7-10 days | |
| The comparison of patient satisfaction according to satisfaction questionnaire | 7-10 days | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Neutec R&D | Contact | 00902128505102 | iremkaraman@neutecrdc.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erzincan University Mengücek Gazi Training and Research Hospital | Recruiting | Erzincan | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D000077525 | Cefdinir |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
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|
| Cefdinir 300Mg Capsule | Drug | Cefdinir is used as comparator |
|
| The comparison of adverse events |
| 7-10 days |
| Yedikule Chest Diseases Training and Research Hospital | Recruiting | Istanbul | Turkey (Türkiye) |
|
| Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |