Health Condition 1: J00-J99- Diseases of the respiratory system
Conditions
Interventions
Intervention1: Augmentin (ES)-600: Augmentin (ES)-600
Type: Drug
Dose Formulation: Suspension
Unit Dose Strength: Each 5 mL of the reconstituted suspension contains:
Amoxicillin Trihydrate IP equival
Sponsors
GlaxoSmithKline Research Development Limited
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosis of AOM on basis of otoscopic findings as defined below Purulent otorrhea of less than 24 hours duration OR Middle ear effusion (MEE) Middle ear effusion is evidenced by at least two of the following: Decreased or absent tympanic mobility measured by pneumatic otoscopy, Yellow or white discoloration of the tympanic membrane, or Opacification of the tympanic membrane PLUS At least one of the following indicators of acute inflammation: Ear pain within 24 hours, including unaccustomed tugging or rubbing of ear, Marked redness of the tympanic membrane, or Distinct fullness or bulging of the tympanic membrane. OR Child with ABRS with inflammation as bacterial infection who has the following symptoms/signs on the day of or the day before the first dose of the investigational product: Redness of the nasal mucosa. Nasal or postnasal discharge is purulent or mucopurulent. Pathological shadow in the paranasal sinus on a radiogram (only for reference-based on investigator discretion). Patient with surgical history should be excluded but patient with a pervious surgery more than 365 days before and apparently preserved maxillary sinus mucosa or patient with a previous surgery of nasal polypectomy more than 90 days before may be enrolled in the study. Child with ABRS whose severity is classified as moderate or severe (total score greater than or equal to 4) based on the nasal cavity findings and symptoms as shown below. Symptom: Rhinorrhoea- None: 0 Mild/Small amount : 1 Moderate or severe: 2 Symptom: Bad mood/ productive cough- None: 0 Mild/Small amount : 1 Moderate or severe: 2 Nasal cavity finding: Nasal/postnasal discharge- None: 0 (Serous) Mild/small amount: 2 (Mucopurulent, small amount) Moderate or severe: 4 (Moderate or larger amount) OR Child diagnosed with CABP based on following criteria: (At least three of the four criteria should be met to include in the study) i. History of documented fever (rectal, ear, or oral temperature >=38°C or axillary temperature >=37.5°C) or hypothermia (rectal, ear, or oral temperature ii. Acute onset or worsening within the previous 5 days of at least two of the following nine clinical signs and symptoms: •cough, •tachycardia, defined as follows: â?ª6 months to =160 beats/min â?ª24 months to =140 beats/min â?ª>=10 years: >=100 beats/min •tachypnea, defined as follows: â?ª6 months to =50 breaths/min â?ª12 months to =40 breaths/min â?ª>=5 years: >=20 breaths/min •dyspnea, •grunting, •sputum production, •chest pain, •cyanosis, •increased work of breathing iii. At least one of the five following laboratory findings: •leukocytosis ( >15,000 white blood cells/mm3 ) • >15% immature neutrophils (bands) regardless of total peripheral white blood cell (WBC), •leukopenia (4,500 WBC/mm3 )and iv. Presence with new infiltrates consistent with bacterial pneumonia including new alveolar or lobal infiltrate or consolidation (based on imaging result) - based on investigatorâ??s discretion only 3. The participant and parent(s)/legal guardian(s) are willing and able to comply with
Exclusion criteria
Exclusion criteria: Participants will be excluded from the study if they meet any of the following exclusion criteria: 1. Weight >= 40 kg 2. Pre-existing renal insufficiency (eg, plasma creatinine >1.5 times upper limit of normal range for age) 3. Pre-existing liver disease(s) and/or hepatic dysfunction 4. A serious underlying disease as per clinicianâ??s judgment. 5. Currently having diarrhea at the time of screening 6. Concomitant infection which would preclude evaluation of the response to study intervention. 7. Concomitant condition precluding evaluation of clinical response (such as acute mastoiditis, facial palsy, bacterial meningitis, and brain tumor) that would preclude evaluation of the response to study intervention. 8. Congenital disorders such as maxillofacial dysplasia. 9. Spontaneous perforation of the tympanic membrane and drainage for longer than 24 hours. 10. Tympanoplastic tube(s) in place, or has anatomic abnormalities associated with recurrent AOM, prolonged middle ear effusion, including cleft palate or repair, high-arched palate, or Downâ??s syndrome. 11. Severe cases of CABP including Hypoxemic, Septic, Ventilator-associated or hospital-acquired pneumonia 12. Need corticosteroid for systemic (inhalational steroids as controller therapy in asthma is allowed) 13. Infectious mononucleosis 14. Evidence of leukopenia and/or thrombocytopenia. 15. History of previous hypersensitivity reaction to penicillins, cephalosporins or other Beta-lactam antibiotics. 16. History of AMC/CVA-associated cholestatic jaundice/hepatic dysfunction. 17. History of phenylketonuria or a known hypersensitivity to aspartame. 18. Received, within 48 hours of study entry, or is scheduled to receive during the study period, any medication which may alter bowel function. 19. Currently receiving or has received more than one dose of systemic antibiotic therapy within one week prior to the initiation of the study. 20. Receipt of an investigational compound (non-FDA and non-DCGI approved) or device within the previous 30 days or five half-lives, whichever is longer, preceding the first dose of study intervention or during the study. 21. Participants with symptoms suggestive of active COVID-19 infection (ie, fever, cough, etc). 22. Participants with known COVID-19 positive contacts within the past 14 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the study is to assess treatment-emergent adverse events (TEAEs) in children receiving Augmentin (ES)-600 (AMC/CVA 14:1) at 90/6.4 mg/kg/day in two divided doses, administered for 10 days in ARTIs(AOM, ABRS or CABP).Timepoint: Safety parameter is TEAE and will be assessed at all visits- Day 0 to Day 28. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective of the study is to assess clinical efficacy and incidence of protocol defined diarrhoea (PDD) in children receiving Augmentin (ES)-600 AMC/CVA 14:1 at 90/6.4 mg/kg/day in two divided doses administered for 10 days in ARTIs (AOM, ABRS or CABP).Timepoint: Efficacy assessment will be based on: 1. Early clinical response at the on-therapy visit (Day 3 to 5) 2. Primary clinical response at the end of therapy visit (Day 12 to 14) 3. Secondary clinical response at follow-up (day 22 to 28) Incidence of protocol-defined diarrhea (PDD)in children receiving Augmentin (ES)-600 (AMC/CVA 14:1) at 90/6.4 mg/kg/day in two divided doses administered for 10 days in ARTIs (AOM, ABRS or CABP). | — |
Countries
India
Contacts
Public ContactAshwini Pawar
Medical Affairs, GSK
Outcome results
None listed