Health Condition 1: J22- Unspecified acute lower respiratory infection
Conditions
Interventions
Intervention1: Amoxicillin and Clavulanate Potassium for Oral Suspension (600 mg+42.9 mg) per 5 ml as per body weight: Drug: Amoxicillin and Potassium Clavulanate 600/42.9mg / 5ml
Route/mode of admini
Sponsors
Alkem Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either gender, aged between greater than equal to 6 months and less than 18 years. 2. Clinical diagnosis of Acute Respiratory Tract Infections (Upper Respiratory Tract Infections (AOM, tonsillopharyngitis, or sinusitis) or Lower Respiratory Tract Infections (lobar and bronchopneumonia)) i) Diagnosis of AOM confirmed if any of the following is present a)Purulent otorrhea for less than than 24 hours b)Middle ear effusion (MEE) diagnosed based on the presence of at least two of the following otoscopic findings A) decreased or absent tympanic mobility, B) yellow or white discoloration of the tympanic membrane, C) opacification of the tympanic membrane, D) acute inflammation at least any one: ear pain within 24 hours with tugging or rubbing of ear, marked redness of the tympanic membrane, distinct fullness or bulging of the tympanic membrane ii) Diagnosis of tonsillopharyngitis confirmed based on a) Sore throat associated with erythema and/or pharyngeal or tonsillar exudate with or without scarlatiniform rash b) Presence or absence of fever and/or general malaise iii) Diagnosis of sinusitis confirmed based on the following a) Inflammation of nasal mucosa, b) Purulent/mucopurulent nasal or postnasal discharge c) Total score of the following symptoms (suggestive of moderate or severe ABRS) A) rhinorrhea (none 0, mild/small amount 1, moderate or severe 2); B) bad mood/productive cough (none 0, mild/small amount 1, moderate or severe: 2); C) nasal/postnasal discharge [none 0 (serous), mild/small amount 1 (mucopurulent, small amount), moderate or severe: 2 (moderate or larger amount)] iv) Diagnosis of lobar and bronchopneumonia confirmed if microbiology-based confirmatory tests are available and if at least three of the following criteria are present a) History of fever (oral temperature greater than 38 C or axillary temperature greater than 37.5 C) or hypothermia (oral temperature less than 35 C or axillary temperature less than 34.5 C) b) Acute onset or worsening of at least two of the following within past 3 days of enrolment A) cough, B) respiratory distress C) tachycardia (greater than 6 months to less than 24 months: greater than 160 beats/min; greater than 24 months to less than 10 years greater than 140 beats/min; greater than 10 years greater than 100 beats/min) (if available in clinical and medical records) D) tachypnea (greater than 6 months to less than 12 months: greater than 50 breaths/min; greater than 12 months to less than 5 years greater than 40 breaths/min; greater than 5 years greater than 20 breaths/min) (if available in clinical and medical records) c) Presence of infiltrates including new alveolar or lobal infiltrate or consolidation as visible on imaging (if available in clinical and medical records) 3. Not requiring hospitalization based on the investigators opinion. 4. Ineffective antimicrobial response within 72 hours of initial treatment (except for AOM). 5. Participants LAR willing to provide informed consent for study participation
Exclusion criteria
Exclusion criteria: 1. History of or pre-existing renal insufficiency, hepatic dysfunction, or immunodeficiency 2. Congenital disorders such as maxillofacial dysplasia or Down s syndrome 3. Spontaneous perforation of the tympanic membrane and drainage for longer than 24 hours 4. Tympanoplastic tube(s) in place, or has anatomic abnormalities associated with recurrent AOM, prolonged MEE, including cleft palate or repair, high-arched palate 5. ABRS patient with surgical history (patient with a pervious surgery is greater than equal to 365 days before and apparently preserved maxillary sinus mucosa or patient with a previous surgery of nasal polypectomy is greater than equal to 90 days before may be considered) 6. Severe cases of CABP including hypoxemic, septic, ventilator-associated or hospital acquired pneumonia 7. Evidence of infectious mononucleosis, leukopenia and/or thrombocytopenia, or diarrhoea at the time of screening 8. Receiving or has received more than one dose of systemic antibiotic or medication affecting bowel movement at the time of enrolment 9. Any condition or concomitant medication, that in the opinion of the investigator, might affect study outcome 10. Any condition in the patient, that in the opinion of the investigator, might worsen upon participation in the study 11. Known allergy or hypersensitivity to the components of the study medication 12. Participation in another clinical trial within past 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events (AE) and serious adverse events (SAEs) [From start of treatment (Day 1) to follow-up visit at Day 28] (AEs and SAEs will be collected).Timepoint: Day 1, Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with primary clinical response. [From start of treatment (Day 1) to end of therapy visit at Day 12-14] At the end of therapy (EOT) visit (Days 12 to 14),the primary clinical response will be evaluated in terms of the study interventions effectiveness or failure. A clinical cure or improvement will be considered a treatment success at EOT. A participant whose clinical outcome is clinical failure (owing to worsening or non-improvement in symptoms) or unable to determine is considered to have failed the treatment. Timepoint: Day 1, Day 14, Day 28;Proportion of patients with secondary clinical response [From end of treatment visit (Day 12-14) to follow up visit at Day 22-28]. At follow-up (Days 22 to 28), secondary clinical response will be evaluated in terms of the success or failure of the study intervention. Treatment failure will be clinical recurrence or inability to determine, while treatment success will be lasting clinical cure. Timepoint: Day 14, Day 28;Time to clinical response evaluated using disease specific subject diary card.Timepoint: Day 1, Day 14, Day 28;Incidence of protocol defined diarrhoea (PDD) (due to study medication) [From start of treatment (Day 1) to end of therapy visit at Day 12-14] The protocol defines diarrhoea as having three or more watery stools in a single day, four or more loose/watery stools in a single day, two watery stools in a row, or three loose/watery stools in a row.Timepoint: Day 1, Day 14 | — |
Countries
India
Contacts
Public ContactMr Mukesh Jaiswal
Alkem Laboratories Limited
Outcome results
None listed