Health Condition 1: J069- Acute upper respiratory infection,unspecified
Conditions
Interventions
Intervention1: Cefditoren Pivoxil 100mg/5ml: Cefditoren pivoxil 100mg/5ml oral suspension
Each enrolled subject will be administered the study drug 3 mg/kg/dose for 10 days to be consumed three times
Sponsors
Zuventus Healthcare Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children between the age of 1-5 years of both gender, with a clinical diagnosis of acute respiratory tract infection suggestive of a bacterial etiology in the opinion of the investigator and can be managed with oral antibiotic therapy 2. Written informed consent from the parent/guardian
Exclusion criteria
Exclusion criteria: 1. Presence of active convulsions, child is unconscious or lethargic, not feeding or vomiting continuously. 2. Presence of chest in-drawing or stridor in a calm child 3. Presence of severe febrile disease complicated severe malnutrition. 4. Use of antibiotics for any other indication in the three weeks prior to enrollment 5. Evidence of any severe bacterial infection requiring parenteral antibiotics. 6. Presence of any severe comorbidities such as haematological or oncological, immunodeficiency, congenital heart disease, neuromuscular impairment, development disorder, including downs syndrome, bronchopulmonary dysplasia, cystic fibrosis, primary ciliary dyskinesia, poorly controlled asthma or other severe chronic lung diseases, which in the opinion of the Investigator renders the subject unfit to participate in the trial. 7. History of known allergy to cefditoren pivoxil or any cephalosporins, penicillins. 8. Participating or planning to participate in another trial that might affect the current study 9. Any reason why, in the opinion of the investigator, the subject should not participate (e.g. not able to comply with study procedures)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the study is to evaluate the clinical cure rate of Cefditoren Pivoxil in acute respiratory tract infectionsTimepoint: Clinical Cure Rate: Number and proportion of children with clinical cure at end of study visit (Day 11) defined as the disappearance of clinical signs and symptoms observed at baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective of the study is to evaluate the clinical response rate and clinical failure rate of Cefditoren Pivoxil in acute respiratory tract infections and to evaluate the microbiological cure rate in those subjects who had a positive Polymerase Chain Reaction (PCR) for the causative pathogens (Streptococcus pneumoniae, moraxella catarrhalis and Haemophilus influenza) at baseline.Timepoint: Clinical Response Rate: Number and proportion of children with clinical improvement at Day 7 Microbiological Cure Rate: Number and proportion of children who have a negative PCR at the end of the study (day 11) amongst those who had a positive PCR for causative pathogens (Streptococcus pneumoniae, moraxella catarrhalis and Haemophilus influenza) at baseline Clinical Failure Rate: Number and proportion of children with unchanged or worsened symptoms at day 7 | — |
Countries
India
Contacts
Public ContactDr Monjori Mitra
Medclin Research
Outcome results
None listed