To evaluate the efficacy & safety of Fixed Dose Combination of Cefpodoxime 200 mg + Clavulanic acid 125 mg tablet VS Cefpodoxime 200 mg tablet in treatment of patients with acute bacterial sinusitis.

Phase 4

Completed

• Conditions: Health Condition 1: null- Acute Bacterial Sinusitis

• Registration Number: CTRI/2012/02/002458
• Lead Sponsor: ABBOTT HEALTHCARE PRIVATE LIMITED

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 220

Inclusion Criteria

1. Male and Females aged 18 years and above.

2. Patients with at least 4 of the signs and symptoms mentioned below

• Nasal congestion/stuffiness

• Sinus Pain

• Headache

• Rhinorrhea

• Cough

• Maxillary toothache

• Energy level

• Difficulty in sleeping

• Anorexia

• Fever

• Sinus X-ray

3. Subject willing to consume oral therapy

4. Patients must give written informed consent after reading the Patient Information sheet and

Informed Consent Form and having had the opportunity to discuss the study with the Investigator.

5. Patient willing to follow up and comply with the Protocol requirements.

Exclusion Criteria

1. Patients with chronic sinusitis (defined as duration of current symptoms for more than 4 weeks (28 days) or more than 2 other episodes of acute sinusitis within previous 12 months)

2. Patients with complicated sinusitis

3. Patient with nosocomial sinusitis

4. Patient with antibiotic use within the past week.

5. Patients with a known allergy to any of ingredients of investigational product and/or comparator product.

6. Patient with history of sinus surgery.

7. Patients with a previous history of cholestatic jaundice/ hepatic dysfunction

8. Pregnant and lactating females.

9. Patient requiring systemic antimicrobial agents therapy within 48 hrs of study entry

10. Patient not willing to participate in the trial or not in position to give the informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified