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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-006220-19-SI

Enrollment

2000

Registered

2008-09-01

Start date

2008-11-27

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute pharyngitis/tonsilitis acute sinusitis acute otitis media acute exacerbation of chronic bronchitis community acquired pneumonia MedDRA version: 9.1 Level: LLT Classification code 10001002 Term: Acute pharyngitis MedDRA version: 9.1 Level: LLT Classification code 10001093 Term: Acute tonsillitis MedDRA version: 9.1 Level: LLT Classification code 10001076 Term: Acute sinusitis MedDRA version: 9.1 Level: LLT Classification code 10033079 Term: Otitis media acute MedDRA version: 9.1 Level:

Interventions

Trade Name: SUMAMED® filmsko obložene tablete 500 mg Pharmaceutical Form: Tablet INN or Proposed INN: AZITHROMYCIN CAS Number: 83905015 Concentration unit: mg milligram(s) Concentration type: equal Co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Male or female out-patients Acute onset of disease indicated by presence of fever ( >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

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)

Design outcomes

Primary

Measure	Time frame
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 To screen the dynamics in the regression of clinical symptoms during the treatment 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 not-evaluable tolerability	—

Measure

Time frame

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 To screen the dynamics in the regression of clinical symptoms during the treatment 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 not-evaluable * tolerability

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Countries

Slovenia

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026