Contact information
Type
Scientific
Primary contact
Mrs Tea Andabaka
ORCID ID
Contact details
Ulica grada Vukovara
Zagreb
10000
Croatia
+385 (0)1 6120 717
Tea.Andabaka@pliva.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SUM-2006/01-INT
Study information
Scientific title
Safety and efficacy of Sumamed® therapy in the treatment of respiratory tract infections in adults and children: international, multicentre, non-comparative study
Acronym
SuPoRTI
Study hypothesis
In the last twenty years resistance of bacteria causing respiratory tract infections increased, but reports on how that affects the results of the treatment are scarce and controversial. This phase IV study is designed to capture real-world efficacy and safety data of Sumamed® (azithromycin) therapy in the population of 2,000 patients, adults and children with bacterial respiratory tract infections. The conditions will include the following:
1. Acute pharyngitis/tonsillitis
2. Acute sinusitis
3. Acute otitis media
4. Acute exacerbation of chronic bronchitis
5. Community acquired pneumonia
Ethics approval
Ethics approvals have been obtained for the lead centres in the following countries:
1. Bosnia and Herzegovina: Federal Ethics Committee (Federalno ministarstvo zdravstva - Federalno eticko povjerenstvo). Date of approval: 27/02/2008
2. Croatia: Central Ethics Committee for Medicines and Medical Products (Sredinje eticko povjerenstvo za lijekove i medicinske proizvode Ksaverska cesta 4). Date of approval: 31/03/2008
3. Macedonia: Medical Ethics Committee, Skopje (Eticka komisija za medicinski istrauvanja Medicinski fakultet 1000 Skopje). Date of approval: 17/01/2008
4. Slovenia: Ethics Committee, Institute of Clinical Neurophysiology (Intitut za klinicno nevrofiziologijo Republika komisija za medicinsko etiko). Date of approval: 07/04/2008
Approvals are pending for the lead centres in the following countries:
5. Hungary: Central Ethics Committee (Egészségügyi Tudományos Tanács Klinikai Farmakológiai Etikai Bizottság [ETT KFEB])
6. Poland: Ethics Committee, Medical University of Lódz (Komisja Bioetyczna przy Uniwersytecie Medycznym, Uniwersytet Medyczny w Lodzi)
7. Romania: National Ethics Committee
8. Russia: Central Ethics Committee attached to the Federal Service on Surveillance in Healthcare and Social Development
9. Ukraine: Central Ethics Committee attached to the Ministry of Health
Information on ethics approval to be confirmed for lead centres in the following countries:
10. Belarus
11. Czech Republic
12. Kazahstan
Study design
Phase IV observational open non-comparative international multicentre study
Primary study design
Observational
Secondary study design
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Bacterial respiratory tract infections
Intervention
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
Intervention type
Drug
Phase
Phase IV
Drug names
Azithromycin
Primary outcome measure
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 measures
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
Overall trial start date
16/06/2008
Overall trial end date
15/06/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Patient
Age group
All
Gender
Both
Target number of participants
2,000
Participant 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
Recruitment start date
16/06/2008
Recruitment end date
15/06/2009
Locations
Countries of recruitment
Belarus, Bosnia and Herzegovina, Croatia, Czech Republic, Hungary, Kazakhstan, Macedonia, Poland, Romania, Russian Federation, Slovenia, Ukraine
Trial participating centre
Ulica grada Vukovara
Zagreb
10000
Croatia
Sponsor information
Organisation
PLIVA Hrvatska d.o.o (Croatia)
Sponsor details
Ulica grada Vukovara 49
Zagreb
10000
Croatia
-
Tea.Andabaka@pliva.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
PLIVA Hrvatska d.o.o. (Croatia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26489107