Comparison of Cefdinir and Cefdinir/Clavulanic Acid Combination in Adults

Phase 4

• Conditions: Acute Exacerbation of Chronic Bronchitis; Community-Acquired Pneumoniae
• Interventions: Combination Product: Cefdinir/clavulanic acide 300/125 mg film-coated tablets; Drug: Cefdinir 300Mg Capsule

• Registration Number: NCT03400735
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-03
• Study Start: 2017-11-01
• Status Verified: 2018-01
• Study First Submitted QC: 2018-01-09
• Last Update Submitted: 2018-01-09
• Study First Posted: 2018-01-17
• Last Update Posted: 2018-01-17
• Primary Completion: 2018-04-01
• Study Completion: 2018-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cefdinir 300 mg Capsules	Cefdinir/clavulanic acide 300/125 mg film-coated tablets	-
Cefdinir/clavulanic acide 300/125 mg Film Coated Tablets	Cefdinir 300Mg Capsule	-

Primary Outcome Measures

Name	Time	Method
The comparison of clinical success rates according to laboratory parameters	7-10 days

Secondary Outcome Measures

Name	Time	Method
The comparison of adverse events	7-10 days
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

Trial Locations

Locations (2)

Yedikule Chest Diseases Training and Research Hospital; 🇹🇷 İstanbul, Turkey

Erzincan University Mengücek Gazi Training and Research Hospital; 🇹🇷 Erzincan, Turkey