Comparison of Cefdinir and Cefdinir/Clavulanic Acid Combination in Adults

Comparison of Cefdinir and Cefdinir/Clavulanic Acid Combination in Treatment of Acute Exacerbation of Chronic Bronchitis (AECB) and Community-acquired Pneumonia (CAP) in Adults

Sponsors

Lead Sponsor: Neutec Ar-Ge San ve Tic A.Ş

Source Neutec Ar-Ge San ve Tic A.Ş
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.

Overall Status Unknown status
Start Date 2017-11-01
Completion Date 2018-08-01
Primary Completion Date 2018-04-01
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
The comparison of clinical success rates according to laboratory parameters 7-10 days
Secondary Outcome
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
Enrollment 50
Condition
Intervention

Intervention Type: Combination Product

Intervention Name: Cefdinir/clavulanic acide 300/125 mg film-coated tablets

Description: Cefdinir is already an approved drug. In this study, developed cefdinir/clavulanic acide combination will be compared against to cefdinir alone.

Arm Group Label: Cefdinir 300 mg Capsules

Other Name: Fullcef Plus

Intervention Type: Drug

Intervention Name: Cefdinir 300Mg Capsule

Description: Cefdinir is used as comparator

Arm Group Label: Cefdinir/clavulanic acide 300/125 mg Film Coated Tablets

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

80 Years

Healthy Volunteers:

No

Overall Contact

Last Name: Neutec R&D

Phone: 00902128505102

Email: [email protected]

Location
Facility: Status: Contact: Investigator:
Erzincan University Mengücek Gazi Training and Research Hospital | Erzincan, Turkey Recruiting Edhem Ünver, Assoc Prof Edhem Ünver, Assoc Prof Principal Investigator
Yedikule Chest Diseases Training and Research Hospital | İstanbul, Turkey Recruiting Sedat Altın, Prof Dr Sedat Altın, Prof Dr Principal Investigator Gülşah Günlüoğlu, Assoc Prof Sub-Investigator Nurdan Kalkan, MD Sub-Investigator
Location Countries

Turkey

Verification Date

2018-01-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Cefdinir/clavulanic acide 300/125 mg Film Coated Tablets

Type: Experimental

Label: Cefdinir 300 mg Capsules

Type: Active Comparator

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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