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

• Register: ISRCTN
• Last refreshed on: 17 October 2016
• Main ID: ISRCTN38391551
• Date of registration: 22/09/2008
• Prospective Registration: No
• Primary sponsor: PLIVA Hrvatska d.o.o (Croatia)
• Public title: Sumamed Phase IV Study: Treatment of respiratory tract infections in adults and children
• Scientific title: Safety and efficacy of Sumamed® therapy in the treatment of respiratory tract infections in adults and children: international, multicentre, non-comparative study
• Date of first enrolment: 16/06/2008
• Target sample size: 2000
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN38391551
• Study type: Observational
• Study design: Phase IV observational open non-comparative international multicentre study (Treatment)
• Phase: Phase IV

Countries of recruitment

Belarus, Bosnia and Herzegovina, Croatia, Czech Republic, Hungary, Kazakhstan, Macedonia, Poland, Romania, Russian Federation, Slovenia, Ukraine

Contacts

• Name: Tea Andabaka

Key inclusion & exclusion 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: 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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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

Total duration of follow-up for each participant:
1. For acute pharyngitis/ tonsillitis, acute sinusitis and acute otitis media patients: 10 - 12 days
2. For acute exacerbation of chronic bronchitis and community acquired pneumonia patients: 28 - 32 days

Acute pharyngitis/ tonsillitis, acute sinusitis and acute otitis media patients will visit investigators 3 times (visits 1, 2 and 3). Acute exacerbation of chronic bronchitis and community acquired pneumonia patients will visit investigators 4 times (visits 1, 2, 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

Primary Outcome(s)

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 Outcome(s)

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

Secondary ID(s)

SUM-2006/01-INT

Source(s) of Monetary Support

PLIVA Hrvatska d.o.o. (Croatia)