Safety and Efficacy of Sumamed® Therapy in the Treatment of Respiratory Tract Infections in Adults and Children: International, Multicenter, Non-Comparative Study - SuPoRTI Study

Phase 1

• Conditions: acute pharyngitis/tonsilitisacute sinusitisacute otitis mediaacute exacerbation of chronic bronchitiscommunity acquired pneumonia; MedDRA version: 9.1Level: LLTClassification code 10001002Term: Acute pharyngitis; MedDRA version: 9.1Level: LLTClassification code 10001093Term: Acute tonsillitis; MedDRA version: 9.1Level: LLTClassification code 10001076Term: Acute sinusitis; MedDRA version: 9.1Level: LLTClassification code 10033079Term: Otitis media acute; MedDRA version: 9.1Level: LLTClassification code 10000743Term: Acute exacerbation of chronic bronchitis; MedDRA version: 9.1Level: LLTClassification code 10010120Term: Community acquired pneumonia

• Registration Number: EUCTR2006-006220-19-CZ
• Lead Sponsor: PLIVA Hrvatska d.o.o.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-06
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

Male or female out-patients
Acute onset of disease indicated by presence of body temperature ( >37oC)
Presence of at least 2 specific clinical signs and symptoms (depending on the diagnosis)
X-ray confirmation of CAP
Signed informed consent (for minors, parent or legal guardian written consent needs to be obtained)

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Hypersensitivity to macrolides
Treatment with any antibiotic within 14 days prior to enrollment
Participation in any clinical study within 4 weeks prior to enrollment
Prior enrollment in this study
Tachypnea (> 20 breaths/min for adults, or more than two standard deviations appropriate for the age of the child)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate clinical efficacy and safety of Sumamed® therapy in the treatment of respiratory tract infections in a significant number of adults and children;Secondary Objective: To determine independent factors associated with the treatment outcome<br>To screen the dynamics in the regression of clinical symptoms during the treatment<br>To compare results from this clinical trial with early clinical studies;Primary end point(s): *clinical efficacy of Sumamed® treatment, defined as cure, improvement, failure, or <br> not-evaluable<br><br> * tolerability<br><br><br>