Health Condition 1: J00-J99- Diseases of the respiratory system
Conditions
Interventions
Intervention1: Amoxycillin 600 mg per 5 mL and Potassium Clavulanate 42.9 mg per 5 mL Oral Suspension: Oral suspension to be administered according to weight of the child (45 mg Amoxycillin and 3.2 m
Sponsors
Sun Pharmaceuticals Industries Limited SPIL
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children of either gender, aged between =3 months and 2. Confirmed clinical diagnosis of URTI [acute otitis media (AOM) OR tonsillo-pharyngitis OR acute bacterial sinusitis] OR LRTI [lobar pneumonia and/or bronchopneumonia] for which patient require treatment with Amoxycillin and Potassium Clavulanate Oral Suspension based on Investigator’s opinion 3. Parent/Legal guardian is willing to give written informed consent and patient willing to give oral assent if aged 7 to 4. Patient able to swallow study medications and follow study protocol 5. For females of childbearing potential, parents should confirm that the patient is not pregnant and investigator should also confirm the same. In case of any doubt, investigator should conduct urine pregnancy test (UPT). Note: However, if pregnancy is detected any time after enrolment, then parents should inform the investigator and the patient should be withdrawn from the study.
Exclusion criteria
Exclusion criteria: 1. Patients weighing >40 kg 2. Suspicion of non-infectious or viral aetiology 3. Patients with complicated URTI/ LRTI requiring intravenous antibiotics or hospitalisation 4. Patient with history of prior lung conditions 5. Patient with history of pulmonary tuberculosis 6. Patient having history of hypersensitivity to penicillin or any beta-lactam antibiotics 7. Patient having history of amoxycillin-clavulanate associated cholestatic jaundice/ hepatic impairment 8. Patient having history of bleeding disorder or currently on anticoagulants 9. Patient with history of phenylketonuria 10. Patient undergoing haemodialysis 11. Patients on probenecid or allopurinol 12. Patients with any clinically significant condition which in the opinion of Investigator would compromise the well-being of the patient or the conduct of the study, or prevent the patient from meeting or performing study requirements. 13. Patients with high risk of carrying amoxycillin-resistant organisms [received amoxycillin or penicillin or other beta-lactam antimicrobials in the last 30 days, OR history of methicillin-resistant Staphylococcus aureus (MRSA) infection] 14. Patient using other antimicrobials in last 30 days 15. Patient with history or current signs and symptoms suggestive of renal impairment (e.g., puffiness of face, pedal oedema, ascites, abnormal urine output etc.) 16. Patient with history or current signs and symptoms suggestive of hepatic impairment (e.g., icterus, anemia, ascites, pain in abdomen, abnormal internal bleeding etc.) 17. Patient with history or current serious underlying disease like but not limited to epilepsy, congenital disorder, metabolic disorder, cardiovascular disease, hepatic disorder, renal disorder, intestinal perforation or obstruction, congenital gastro-intestinal malformation, genito-urinary disorder etc. 18. Concomitant infection which would preclude evaluation of the response of his/her URTI/ LRTI to the study intervention. 19. Patient with history of Human Immunodeficiency Virus (HIV) and / or Hepatitis B and/ or Hepatitis C 20. Patients with other disease or medication leading to immune-compromised condition 21. Patient with history of significant active peptic ulceration 22. Patient with history of cancer or undergoing cancer chemo or radiotherapy 23. Patient who have participated in another Investigational study within the 3 months prior to enrolment in this study 24. Patient with known alcohol or other substance abuse within last one year 25. Employee of the Sponsor, Investigator, or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members of the employees of Sponsor or the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with treatment-emergent adverse events (TEAEs)Timepoint: Throughout the study period | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants with diarrhoeaTimepoint: Throughout the study period;Proportion of participants with serious adverse events (SAEs)Timepoint: Throughout the study period;Proportion of patients achieving clinical cureTimepoint: End of study;Proportion of patients with clinical failureTimepoint: End of study;Proportion of patients with clinical improvementTimepoint: End of study;Proportion of patients with clinical relapseTimepoint: End of study;Time to symptom resolution (based on patient report)Timepoint: Day 1 to End of study | — |
Countries
India
Contacts
Public ContactSucheta A Pandit
Sun Pharma Laboratories Limited
Outcome results
None listed