Comparison of Cefdinir and Cefdinir/Clavulanic Acid Combination in Adults
NCT ID: NCT03400735
Last Updated: 2018-01-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
50 participants
INTERVENTIONAL
2017-11-01
2018-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cefdinir/clavulanic acide 300/125 mg Film Coated Tablets
Cefdinir 300Mg Capsule
Cefdinir is used as comparator
Cefdinir 300 mg Capsules
Cefdinir/clavulanic acide 300/125 mg film-coated tablets
Cefdinir is already an approved drug. In this study, developed cefdinir/clavulanic acide combination will be compared against to cefdinir alone.
Interventions
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Cefdinir/clavulanic acide 300/125 mg film-coated tablets
Cefdinir is already an approved drug. In this study, developed cefdinir/clavulanic acide combination will be compared against to cefdinir alone.
Cefdinir 300Mg Capsule
Cefdinir is used as comparator
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The diagnosis of community-acquired pneumoniae
* FEV1 value = 30-80%
* The diagnosis of mild-severe acute exacerbation of chronic bronchitis (AECB)
* Oxygen saturation \< 90%
Exclusion Criteria
* Allergy against to penicillin or cephalosporins
* Renal impairment
* Active hepatic disease
* Antibiotic use except study drugs
* Immunosuppressive therapy before 6 months of study initiation
* Use of probenecid like drugs
18 Years
80 Years
ALL
No
Sponsors
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Neutec Ar-Ge San ve Tic A.Ş
INDUSTRY
Responsible Party
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Locations
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Erzincan University Mengücek Gazi Training and Research Hospital
Erzincan, , Turkey (Türkiye)
Yedikule Chest Diseases Training and Research Hospital
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Edhem Ünver, Assoc Prof
Role: primary
Sedat Altın, Prof Dr
Role: primary
Other Identifiers
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NEU-08.16
Identifier Type: -
Identifier Source: org_study_id
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