Comparison of Cefdinir and Cefdinir/Clavulanic Acid Combination in Adults
1 other identifier
interventional
50
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Nov 2017
Shorter than P25 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2016
CompletedStudy Start
First participant enrolled
November 1, 2017
CompletedFirst Posted
Study publicly available on registry
January 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedJanuary 17, 2018
January 1, 2018
5 months
October 3, 2016
January 9, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
The comparison of clinical success rates according to laboratory parameters
7-10 days
Secondary Outcomes (3)
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
Study Arms (2)
Cefdinir/clavulanic acide 300/125 mg Film Coated Tablets
EXPERIMENTALCefdinir 300 mg Capsules
ACTIVE COMPARATORInterventions
Cefdinir is already an approved drug. In this study, developed cefdinir/clavulanic acide combination will be compared against to cefdinir alone.
Cefdinir is used as comparator
Eligibility Criteria
You may qualify if:
- 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%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Erzincan University Mengücek Gazi Training and Research Hospital
Erzincan, Turkey (Türkiye)
Yedikule Chest Diseases Training and Research Hospital
Istanbul, Turkey (Türkiye)
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2016
First Posted
January 17, 2018
Study Start
November 1, 2017
Primary Completion
April 1, 2018
Study Completion
August 1, 2018
Last Updated
January 17, 2018
Record last verified: 2018-01