To compare two formulations of amoxicillin + clavulanic acid in respiratory infections
Phase 4
Completed
- Conditions
- Health Condition 1: null- upper respiratory tract infections
- Registration Number
- CTRI/2015/07/005971
- Lead Sponsor
- SUN PHARMACEUTICAL INDUSTRIES LIMITED
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
Pediatric Patients aged between 2 to 7 years of age with upper respiratory tract infections like acute otitis media or tonsillitis or sinusitis
Exclusion Criteria
ii.Subjects requiring hospitalization
iii.Subjects with known or suspected hypersensitivity to penicillins
iv.Subjects who have received antimicrobial therapy within 7 days prior to enrollment.
v.Patient who severe complications of RTI.
vi.Critically ill patients
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ï?¼To evaluate and compare the decrease in severity of clinical signs and symptoms from baseline to Day 3 and Day 7.Timepoint: Day 3 and Day 7
- Secondary Outcome Measures
Name Time Method ï?¼The percent change from in safety parameter viz. incidence of Diarrhea at Baseline, 3, and 7 days of treatmentTimepoint: Day 3 and Day 7.