Health Condition 1: J069- Acute upper respiratory infection,unspecified
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Control Intervention2: NIL: NIL
Sponsors
Alembic Pharmaceuticals Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: Patients must meet all of the following criteria to be included in this study: 1) Pediatric patients, aged 2-12 years of age(inclusive of both) of either gender with acute onset of pharyngitis/ tonsillitis/ otitis media as indicated by presence of fever, visiting to outpatient department of pediatrics and whose parents/ Legally acceptable representative (LAR) are ready to participate in the study by signing the written informed consent. 2) Pediatric patients suitable for receiving azithromycin based on investigator s clinical judgement and locally approved prescribing information. 3) For patients with acute pharyngitis/ tonsillitis/ pharyngo-tonsillitis, presence of at least two specific clinical symptoms and signs such as: A)Clinical Symptoms: sore throat; pharyngeal erythema; tonsillar erythema B)Clinical signs: tonsillar enlargement and erythema; tonsillar exudates; painful cervical lymphadenopathy 4) For patients with acute Otitis Media, A) Presence of middle ear effusion indicated by any of the following: a) Bulging of tympanic membrane b) Limited or absent motility of tympanic membrane c) Air-fluid level behind the tympanic membrane B) Signs and Symptoms of middle ear inflammation as indicated by either a) Distinct erythema of tympanic membrane or b) Distinct otalgia or irritability (discomfort clearly referable to the ears that results in interference with or precludes normal activity or sleep)
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from this study: 1) Pediatric Patients with URTIs those who are not suitable to receive Azithromycin (Allergic, Contraindication, receiving antibiotic other than Azithromycin) based on investigator s judgement. 2) Patients with LRTIs or any other clinical conditions requiring treatment with antibiotics/ antimicrobials. 3) Participation in any clinical study within 4 weeks prior to enrolment 4) Patient suggestive of complicated Acute otitis media with anyone of : a)Signs and symptoms of any complication of AOM b)Otitis externa c)Tympanostomy tubes presence. 5) Patients not suitable to receive Azithromycin Liquid formulation (Weight of patient above 50 kg)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical effectiveness to azithromycin will be assessed on the basis of mean reduction in total clinical score for assessing regression of signs & symptoms at 7 1 dayTimepoint: Clinical effectiveness at Day 1(first visit) and Day 7(Follow up visit) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Number (proportion) of patients showing mean reduction in total clinical score as assessed at 7 1 day evaluated as A) Cure: Complete disappearance of signs & symptoms present at 7 1 day B) Improvement: Defervescence with substantial reduction in intensity of signs & symptoms present at 7 1 day & no need of additional antimicrobial therapy C) Failure: Progression or recurrence of signs & symptoms & introduction of other antimicrobial therapy 2) Safety- Will be assessed based on number & severity of adverse events 3) Compliance assessment Will be assessed based on medication history (Dose & frequency of intake) at 7 1 day 4) Palatability assessment Will be as assessed by parents/ legal guardian based on facial hedonic scale 7 1 day Timepoint: 1) Number (proportion) of patients showing mean reduction in total clinical score at 7 1 day 2) Safety assessment at 7 1 day 3) Compliance assessment at 7 1 day 4) Palatability assessment at 7 1 day | — |
Countries
India
Contacts
Public ContactDr Dinesh Patil
Alembic Pharmaceuticals Limited
Outcome results
None listed