Condition category
Infections and Infestations
Date applied
13/06/2008
Date assigned
22/09/2008
Last edited
23/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.pliva.com/hr

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

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26489107

Publication citations

Additional files

Editorial Notes