Acute Exacerbation of Chronic Bronchitis, Community-Acquired Pneumoniae
Conditions
Brief summary
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.
Interventions
COMBINATION_PRODUCTCefdinir/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.
DRUGCefdinir 300Mg Capsule
Cefdinir is used as comparator
Sponsors
Neutec Ar-Ge San ve Tic A.Ş
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* The diagnosis of chronic bronchitis * 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
* Pregnancy or breastfeeding * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The comparison of clinical success rates according to laboratory parameters | 7-10 days |
Secondary
| Measure | 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 |
| The comparison of adverse events | 7-10 days |
Countries
Turkey (Türkiye)
Contacts
Primary ContactNeutec R&D
Outcome results
None listed