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Comparison of Cefdinir and Cefdinir/Clavulanic Acid Combination in Adults

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ClinicalTrials.gov Identifier: NCT03400735
Recruitment Status : Recruiting
First Posted : January 17, 2018
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Acute Exacerbation of Chronic Bronchitis Community-Acquired Pneumoniae Combination Product: Cefdinir/clavulanic acide 300/125 mg film-coated tablets Drug: Cefdinir 300Mg Capsule Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : April 1, 2018
Estimated Study Completion Date : August 1, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Cefdinir

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 Name: Fullcef Plus




Primary Outcome Measures :
  1. The comparison of clinical success rates according to laboratory parameters [ Time Frame: 7-10 days ]

Secondary Outcome Measures :
  1. The comparison of remission or relief of inflammation according to laboratory parameters [ Time Frame: 7-10 days ]
  2. The comparison of patient satisfaction according to satisfaction questionnaire [ Time Frame: 7-10 days ]
  3. The comparison of adverse events [ Time Frame: 7-10 days ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03400735


Contacts
Contact: Neutec R&D 00902128505102 iremkaraman@neutecrdc.com

Locations
Turkey
Erzincan University Mengücek Gazi Training and Research Hospital Recruiting
Erzincan, Turkey
Contact: Edhem Ünver, Assoc Prof         
Principal Investigator: Edhem Ünver, Assoc Prof         
Yedikule Chest Diseases Training and Research Hospital Recruiting
İstanbul, Turkey
Contact: Sedat Altın, Prof Dr         
Principal Investigator: Sedat Altın, Prof Dr         
Sub-Investigator: Gülşah Günlüoğlu, Assoc Prof         
Sub-Investigator: Nurdan Kalkan, MD         
Sponsors and Collaborators
Neutec Ar-Ge San ve Tic A.Ş

Responsible Party: Neutec Ar-Ge San ve Tic A.Ş
ClinicalTrials.gov Identifier: NCT03400735     History of Changes
Other Study ID Numbers: NEU-08.16
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Pneumonia
Bronchitis
Bronchitis, Chronic
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bronchial Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Clavulanic Acids
Clavulanic Acid
Cefdinir
Cephalosporins
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
beta-Lactamase Inhibitors