Comparison of Cefdinir and Cefdinir/Clavulanic Acid Combination in Adults

Neutec Ar-Ge San ve Tic

Status and phase: Unknown; Phase 4

Conditions: Community-Acquired Pneumoniae; Acute Exacerbation of Chronic Bronchitis

Treatments: Drug: Cefdinir 300Mg Capsule; Combination Product: Cefdinir/clavulanic acide 300/125 mg film-coated tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT03400735

NEU-08.16

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Cefdinir/clavulanic acide 300/125 mg Film Coated Tablets

Experimental group

Treatment:

Drug: Cefdinir 300Mg Capsule

Cefdinir 300 mg Capsules

Active Comparator group

Treatment:

Combination Product: Cefdinir/clavulanic acide 300/125 mg film-coated tablets