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

ISRCTN	ISRCTN38391551
DOI	https://doi.org/10.1186/ISRCTN38391551
Secondary identifying numbers	SUM-2006/01-INT

Submission date: 13/06/2008
Registration date: 22/09/2008
Last edited: 23/10/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs Tea Andabaka
Scientific

Ulica grada Vukovara
Zagreb
10000
Croatia

Phone	+385 (0)1 6120 717
Email	Tea.Andabaka@pliva.com

Study information

Study design	Phase IV observational open non-comparative international multicentre study
Primary study design	Observational
Secondary study design
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Safety and efficacy of Sumamed® therapy in the treatment of respiratory tract infections in adults and children: international, multicentre, non-comparative study
Study acronym	SuPoRTI
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Phase IV
Drug / device / biological / vaccine name(s)	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 study start date	16/06/2008
Completion date	15/06/2009

Eligibility

Participant type(s)	Patient
Age group	All
Sex	Both
Target number of participants	2,000
Key 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)
Key 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
Date of first enrolment	16/06/2008
Date of final enrolment	15/06/2009

Locations

Countries of recruitment

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

Study participating centre

Ulica grada Vukovara

Zagreb
10000
Croatia

Sponsor information

PLIVA Hrvatska d.o.o (Croatia)
Industry

Ulica grada Vukovara 49
Zagreb
10000
Croatia

Email	Tea.Andabaka@pliva.com
Website	http://www.pliva.com/hr
"ROR"	https://ror.org/026t6sy78

Funders

Funder type

Industry

PLIVA Hrvatska d.o.o. (Croatia)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2015		Yes	No