Comparison of Cefdinir and Cefdinir/Clavulanic Acid Combination in Adults

NCT ID: NCT03400735

Last Updated: 2018-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2018-08-01

Brief Summary

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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

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Conditions

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Acute Exacerbation of Chronic Bronchitis Community-Acquired Pneumoniae

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cefdinir/clavulanic acide 300/125 mg Film Coated Tablets

Group Type EXPERIMENTAL

Cefdinir 300Mg Capsule

Intervention Type DRUG

Cefdinir is used as comparator

Cefdinir 300 mg Capsules

Group Type ACTIVE_COMPARATOR

Cefdinir/clavulanic acide 300/125 mg film-coated tablets

Intervention Type COMBINATION_PRODUCT

Cefdinir is already an approved drug. In this study, developed cefdinir/clavulanic acide combination will be compared against to cefdinir alone.

Interventions

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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.

Intervention Type COMBINATION_PRODUCT

Cefdinir 300Mg Capsule

Cefdinir is used as comparator

Intervention Type DRUG

Other Intervention Names

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Fullcef Plus

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Neutec Ar-Ge San ve Tic A.Ş

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Erzincan University Mengücek Gazi Training and Research Hospital

Erzincan, , Turkey (Türkiye)

Site Status RECRUITING

Yedikule Chest Diseases Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Neutec R&D

Role: CONTACT

00902128505102

Facility Contacts

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Edhem Ünver, Assoc Prof

Role: primary

Sedat Altın, Prof Dr

Role: primary

Other Identifiers

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NEU-08.16

Identifier Type: -

Identifier Source: org_study_id

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