Comparison of Cefdinir and Cefdinir/Clavulanic Acid Combination in Adults

January 9, 2018 updated by: Neutec Ar-Ge San ve Tic A.Ş

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cefdinir/clavulanic acide 300/125 mg Film Coated Tablets
Drug: Cefdinir 300Mg Capsule
Cefdinir is used as comparator
ACTIVE_COMPARATOR: Cefdinir 300 mg Capsules
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.
Other Names:
  • Fullcef Plus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The comparison of clinical success rates according to laboratory parameters
Time Frame: 7-10 days
7-10 days

Secondary Outcome Measures

Outcome Measure
Time Frame
The comparison of remission or relief of inflammation according to laboratory parameters
Time Frame: 7-10 days
7-10 days
The comparison of patient satisfaction according to satisfaction questionnaire
Time Frame: 7-10 days
7-10 days
The comparison of adverse events
Time Frame: 7-10 days
7-10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neutec Ar-Ge San ve Tic A.Ş

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2017

Primary Completion (ANTICIPATED)

April 1, 2018

Study Completion (ANTICIPATED)

August 1, 2018

Study Registration Dates

First Submitted

October 3, 2016

First Submitted That Met QC Criteria

January 9, 2018

First Posted (ACTUAL)

January 17, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 17, 2018

Last Update Submitted That Met QC Criteria

January 9, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEU-08.16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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