Health Condition 1: B998- Other infectious disease
Conditions
Interventions
Intervention1: Amoxycillin
and Potassium Clavulanate Oral Dispersible Tablet (600 mg/42.9 mg): one tablet twice a day orally, swallowed with water or without water for 7-10 days
Control Intervention1:
Sponsors
MALIK LIFE SCIENCES PVT. LTD.
Ms Malik Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Subjects meeting the following criteria will be included in the study. 1. Male or female patients aged eighteen to sixty five years. 2. Clinical diagnosis of one or more of the following conditions. a. Acute Otitis Media. b. Acute Bacterial Sinusitis. c. Acute Tonsillopharyngitis. d. Lobar pneumonia or bronchopneumonia of mild to moderate severity. 3. Acute onset of symptoms within the last three to seven days. 4. Presence of at least one systemic sign of infection, such as fever of thirty eight degrees Celsius or higher, purulent ear discharge, purulent nasal discharge, purulent pharyngeal discharge, or leukocytosis, if available. 5. Patients not requiring hospitalization or intravenous antibiotic therapy. 6. Willing and able to provide written informed consent. 7. Willing to adhere to the study protocol and attend all scheduled study visits.
Exclusion criteria
Exclusion criteria: Subjects will be excluded from the study for any of the following reasons. 1. Known or suspected hypersensitivity to penicillins, clavulanate, or other beta lactam antibiotics. 2. History of cholestatic jaundice or hepatic dysfunction associated with previous amoxicillin clavulanate therapy. 3. Evidence of moderate to severe renal impairment, defined as an estimated glomerular filtration rate less than sixty milliliters per minute per one point seven three square meters. 4. Suspected or confirmed infectious mononucleosis. 5. Current or recent use of systemic antibiotics or drugs that affect bowel motility within the last seventy two hours. 6. Immunocompromised state, including the following. a. Active chemotherapy or radiotherapy. b. Long term corticosteroid use. c. CD four count less than two hundred in human immunodeficiency virus positive patients. 7. Pregnant or lactating women. 8. Known history of peptic ulcers, inflammatory bowel disease, or antibiotic associated colitis. 9. Any condition, including chronic diseases or concomitant medications, that in the opinion of the investigator may interfere with study conduct or interpretation of results, or may pose a risk to subject safety. 10. Participation in another clinical trial within the last thirty days. 11. Severe pneumonia, defined as the presence of respiratory failure, hypoxemia requiring oxygen therapy, or suspected or confirmed sepsis. 12. Presence of gastrointestinal symptoms at screening, such as vomiting or severe diarrhea, that may interfere with drug absorption.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to evaluate the clinical efficacy of Amoxycillin and Potassium Clavulanate Oral Dispersible Tablet (600 mg/42.9 mg) as compared to Amoxycillin 400 mg Dispersible Tablet in adult patients with acute bacterial infection from Day 1 10Timepoint: The primary objective of this study is to evaluate the clinical efficacy of Amoxycillin and Potassium Clavulanate Oral Dispersible Tablet (600 mg/42.9 mg) as compared to Amoxycillin 400 mg Dispersible Tablet in adult patients with acute bacterial infections from Day 7 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the time to resolution of key infection-related symptoms. To assess the safety & tolerability of the investigational & comparator products. To determine the microbiological eradication rate (where culture data is available). To assess treatment compliance based on dosing records. To evaluate patient acceptability & ease of administration of the dispersible tablet formulation.Timepoint: Number of days from the first dose of study drug to complete resolution of key symptoms i.e. from Day 1 to Day 7-10 | — |
Countries
India
Contacts
Public ContactKamlesh Londhe
Vivotech Research Private Limited
Outcome results
None listed