Health Condition 1: null- Acute Bacterial Sinusitis
Conditions
Interventions
Intervention1: Cefpodoxime 200 mg + Clavulanic acid 125 mg tablets, (CEFCHAMP - 325): Arm-1:
Dose: One tablet twice daily for 10 days
Route of Administration: Oral
Duration of Treatment:
The total
Sponsors
ABBOTT HEALTHCARE PRIVATE LIMITED
Reliance Clinical Research Services a division of Reliance Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response rates will be assessed based on resolution of signs and symptoms from baseline to Day 10. Timepoint: Clinical response rates will be assessed based on resolution of signs and symptoms from baseline to Day 10. | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Proportions of subjects with resolution of sinusitis signs and symptoms at Day 10 ( End-of-Therapy Visits ) â?¢ Global assessment for efficacy and tolerability by investigator and patient at day 10 (End of the therapy visits) Timepoint: At day 10 (End of the therapy visits) | — |
Countries
India
Contacts
Public ContactDr Prashant Pandya
Abbott Healthcare Private Limited
Outcome results
None listed