Comparison of Cefdinir and Cefdinir/Clavulanic Acid Combination in Adults

Acute Exacerbation of Chronic Bronchitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03400735
• Other study ID #: NEU-08.16
• Status: Recruiting
• Phase: Phase 4
• First received: October 3, 2016
• Last updated: January 9, 2018
• Start date: November 1, 2017
• Est. completion date: August 1, 2018

Study information

• Verified date: January 2018
• Source: Neutec Ar-Ge San ve Tic A.S
• Contact: Neutec R&D
• Phone: 00902128505102
• Email: iremkaraman[@]neutecrdc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 1, 2018
• Est. primary completion date: April 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Exacerbation of Chronic Bronchitis
• Bronchitis
• Bronchitis, Chronic
• Community-Acquired Pneumoniae
• Pneumonia

Intervention

Combination Product:
• 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.

Drug:
• Cefdinir 300Mg Capsule
Cefdinir is used as comparator

Locations

Country	Name	City	State
Turkey	Erzincan University Mengücek Gazi Training and Research Hospital	Erzincan
Turkey	Yedikule Chest Diseases Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Neutec Ar-Ge San ve Tic A.S

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The comparison of clinical success rates according to laboratory parameters		7-10 days
Secondary	The comparison of remission or relief of inflammation according to laboratory parameters		7-10 days
Secondary	The comparison of patient satisfaction according to satisfaction questionnaire		7-10 days
Secondary	The comparison of adverse events		7-10 days