Sumamed Phase IV Study: Treatment of respiratory tract infections in adults and childre

Phase 4

Completed

Conditions: Bacterial respiratory tract infections
Infections and Infestations
Other bacterial agents as the cause of diseases classified to other chapters

Registration Number: ISRCTN38391551

Lead Sponsor: PLIVA Hrvatska d.o.o (Croatia)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 2000

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

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

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical efficacy of the treatment defined as cure, improvement, failure or not-evaluable, assessed at visits 3 and 4. <br><br>Timepoints:<br>Visit 1 will take place on Day 1<br>Visit 2 will take place on Day 4<br>Visit 3 will take place between Day 10 - 12<br>Visit 4 will take place between Day 28 - 32

Secondary Outcome Measures

Name	Time	Method
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. <br><br>Timepoints:<br>Visit 1 will take place on Day 1<br>Visit 2 will take place on Day 4<br>Visit 3 will take place between Day 10 - 12<br>Visit 4 will take place between Day 28 - 32