Back to resultsComparison of Cefdinir and Cefdinir/Clavulanic Acid Combination in Adults
Primary Purpose
Acute Exacerbation of Chronic Bronchitis, Community-Acquired Pneumoniae
Status
Unknown status
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Cefdinir/clavulanic acide 300/125 mg film-coated tablets
Cefdinir 300Mg Capsule
Sponsored by
About this trial
This is an interventional treatment trial for Acute Exacerbation of Chronic Bronchitis
Eligibility Criteria
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
Sites / Locations
- Erzincan University Mengücek Gazi Training and Research HospitalRecruiting
- Yedikule Chest Diseases Training and Research HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cefdinir/clavulanic acide 300/125 mg Film Coated Tablets
Cefdinir 300 mg Capsules
Arm Description
Outcomes
Primary Outcome Measures
The comparison of clinical success rates according to laboratory parameters
Secondary Outcome Measures
The comparison of remission or relief of inflammation according to laboratory parameters
The comparison of patient satisfaction according to satisfaction questionnaire
The comparison of adverse events
Full Information
NCT ID
NCT03400735
First Posted
October 3, 2016
Last Updated
January 9, 2018
Sponsor
Neutec Ar-Ge San ve Tic A.Ş
1. Study Identification
Unique Protocol Identification Number
NCT03400735
Brief Title
Comparison of Cefdinir and Cefdinir/Clavulanic Acid Combination in Adults
Official Title
Comparison of Cefdinir and Cefdinir/Clavulanic Acid Combination in Treatment of Acute Exacerbation of Chronic Bronchitis (AECB) and Community-acquired Pneumonia (CAP) in Adults
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
April 1, 2018 (Anticipated)
Study Completion Date
August 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neutec Ar-Ge San ve Tic A.Ş
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Exacerbation of Chronic Bronchitis, Community-Acquired Pneumoniae
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cefdinir/clavulanic acide 300/125 mg Film Coated Tablets
Arm Type
Experimental
Arm Title
Cefdinir 300 mg Capsules
Arm Type
Active Comparator
Intervention Type
Combination Product
Intervention Name(s)
Cefdinir/clavulanic acide 300/125 mg film-coated tablets
Other Intervention Name(s)
Fullcef Plus
Intervention Description
Cefdinir is already an approved drug. In this study, developed cefdinir/clavulanic acide combination will be compared against to cefdinir alone.
Intervention Type
Drug
Intervention Name(s)
Cefdinir 300Mg Capsule
Intervention Description
Cefdinir is used as comparator
Primary Outcome Measure Information:
Title
The comparison of clinical success rates according to laboratory parameters
Time Frame
7-10 days
Secondary Outcome Measure Information:
Title
The comparison of remission or relief of inflammation according to laboratory parameters
Time Frame
7-10 days
Title
The comparison of patient satisfaction according to satisfaction questionnaire
Time Frame
7-10 days
Title
The comparison of adverse events
Time Frame
7-10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Neutec R&D
Phone
00902128505102
Email
iremkaraman@neutecrdc.com
Facility Information:
Facility Name
Erzincan University Mengücek Gazi Training and Research Hospital
City
Erzincan
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edhem Ünver, Assoc Prof
First Name & Middle Initial & Last Name & Degree
Edhem Ünver, Assoc Prof
Facility Name
Yedikule Chest Diseases Training and Research Hospital
City
İstanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sedat Altın, Prof Dr
First Name & Middle Initial & Last Name & Degree
Sedat Altın, Prof Dr
First Name & Middle Initial & Last Name & Degree
Gülşah Günlüoğlu, Assoc Prof
First Name & Middle Initial & Last Name & Degree
Nurdan Kalkan, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Comparison of Cefdinir and Cefdinir/Clavulanic Acid Combination in Adults
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