Bacterial respiratory tract infections Infections and Infestations Other bacterial agents as the cause of diseases classified to other chapters
Conditions
Interventions
Adults and children >=45 kg: azithromycin (oral) 500 mg in the form of tablets once daily for 3 days
Children: azithromycin 10 mg/kg, in the form of powder for oral suspension, once daily for 3 days
Sponsors
PLIVA Hrvatska d.o.o (Croatia)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female out-patients, no age limits 2. Acute onset of disease indicated by presence of fever (>37°C) 3. Presence of at least 2 specific clinical signs and symptoms 4. Signed informed consent (for minors, parent or legal guardian written consent needs to be obtained)
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity to macrolides 2. Treatment with any antibiotic within 14 days prior to enrolment 3. Participation in any clinical study within 4 weeks prior to enrolment 4. Prior enrolment in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical efficacy of the treatment defined as cure, improvement, failure or not-evaluable, assessed at visits 3 and 4. Timepoints: Visit 1 will take place on Day 1 Visit 2 will take place on Day 4 Visit 3 will take place between Day 10 - 12 Visit 4 will take place between Day 28 - 32 | — |
Secondary
| Measure | Time frame |
|---|---|
| Tolerability, assessed through adverse events recorded at visits 2, 3 and 4. Tolerability will be presented as frequencies, percentages and 95% confidence intervals. Results will be presented for the whole group of patients and further stratified according to the clinical diagnosis. Timepoints: Visit 1 will take place on Day 1 Visit 2 will take place on Day 4 Visit 3 will take place between Day 10 - 12 Visit 4 will take place between Day 28 - 32 | — |
Countries
Belarus, Bosnia and Herzegovina, Croatia, Czech Republic, Hungary, Kazakhstan, Macedonia, Poland, Romania, Russian Federation, Slovenia, Ukraine
Outcome results
None listed