Condition category
Respiratory
Date applied
20/02/2019
Date assigned
22/02/2019
Last edited
21/02/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and aims:
Antibiotics are necessary to fight infections especially in children. Unfortunately antibiotics do not only kill bad bacteria – but also affect commensal flora (beneficial bacteria), important to good health. An effect of antibiotics, is depletion of commensal flora and a loss of this protective barrier, that leaves them exposed to a vast variety of diseases.
This study researches if commensal bacteria can benefit during the administration of antibiotics when a prebiotic (Lactulose) is given during treatment. Lactulose, a flora nourishment is expected to allow commensal flora to survive the treatment delivering a more beneficial treatment approach with less adverse effects.

Who can participate?
Children of both sexes, between 3 and 14 years of age, diagnosed with Acute Purulent Sinusitis were included. All subjects had provided written informed consent (signed by parent/guardian) and have agreed not to take other prebiotics, probiotics, synbiotics, and/or sorbents during the course of the study.

What does the study involve?
Patients with diagnosis of Acute Purulent Sinusitis have been treated with antibiotic. Group 1 - with azithromycin plus lactulose (food for beneficial bacteria), one dose a day during three days; Group 2 – with azithromycin, one dose a day during three days. Patients provided stool before and after the treatment, and the stool was analysed on composition of beneficial or pathogenic bacteria.

What are the possible benefits and risks of participating?
Benefits were free treatment, even in the case of leaving/dropping out of the study and contribution to research.
Risks were expected possible adverse events, common and uncommon for the used antibiotic.

Where is the study run from?
This study run only in a single centre in Moscow and took place in Clinical Center 1, Children's City Polyclinic No. 133 of the Department of Health of Moscow.

When is the study starting and how long is it expected to run for?
Study had started on 21st of April, 2015 and ended on 25th of January, 2016.

Who is funding the study?
MC Development, Russia.

Who is the main contact?
Dr Christos Shammas, c.shammas@avvapharma.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Christos Shammas

ORCID ID

http://orcid.org/0000-0001-7295-6587

Contact details

23A
Spyrou Kyprianou
Mesa Yitonia
Limassol
4001
Cyprus
+357 25 572200
c.shammas@avvapharma.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

ECOMED-11/2014

Study information

Scientific title

An open, randomized comparative study of the efficacy and safety of using Ecomed (powder for oral suspension, containing azithromycin 100mg/5ml and lactulose 200mg/5ml, manufactured by JSC AVVA RUS, Russia) compared with Sumamed (powder for suspension, containing azithromycin 100mg/5ml, by Pliva Hrvatska doo, Croatia) in children with rhinosinusitis.

Acronym

ECOMED

Study hypothesis

Comparative evaluation of the clinical efficacy of Ecomed and Sumamed in children with rhinosinusitis.

Ethics approval

Approved 19/01/2015, Local Committee for Research Ethics, (55 Smolnaya str. 125445, Moscow, Russia; +7 (495) 456-32-03; dgp133medved@yandex.ru), ref: GBUZ “DGP No. 13З DZM”

Study design

An open, randomized, single-centre, comparative study of the efficacy and safety of drugs when administered to children with rhinosinusitis.

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Rhinosinusitis in children

Intervention

Dosage regimens:
Ecomed is a powder for suspension, containing 100mg of azithromycin/5ml and 200mg of lactulose/5ml (JSC AVVA RUS, Russia);
Sumamed - suspension powder containing 100mg of azithromycin/5ml (Pliva Hrvatska doo, Republic of Croatia).
Method of administration: administration of oral suspension 1 time per day at the dose of 10mg/kg/day and 20mg/kg/day lactulose, where applicable.
Treatment duration: 3 days.
Observation period: 60 days ± 2 days.
Duration of participation of one patient in the study: 68 days (screening 3 days + 3 days of therapy and + 60±2 days observation period).

The randomization sequences were produced by web-based free randomization resource https://www.randomizer.org/. The study includes screening period, randomization period, period of treatment and monitoring (follow-up). During the research study, 4 visits are conducted: visit 1-screening; visit 2-randomization and start of treatment (baseline); visit 3-completion of treatment (day 3), visit 4- follow up (day 18) and visit 5- follow up (day 60).

Intervention type

Drug

Phase

Phase IV

Drug names

1. Ecomed (powder for oral suspension, azithromycin 100mg/5ml and lactulose 200mg/5ml, by JSC AVVA RUS, Russia)
2. Sumamed (powder for oral suspension, azithromycin 100mg/5ml, by Pliva Hrvatska doo, Croatia)

Primary outcome measure

The proportion of subjects with clinical improvement in the symptoms of the disease assessed by the researcher-clinician on the 4th day from the start of drug administration.
Efficacy is evaluated on the basis of the reduction and disappearance of the main subjective and objective symptoms of bacterial rhinosinusitis - the severity of difficulty in nasal breathing, the nature and severity of discharge from the nose, pain when palpating the projection of the paranasal sinuses, temperature reaction, headache, the presence and severity of general malaise.

Secondary outcome measures

1. Frequency and severity of symptoms of dysbiosis in the background of the studied therapy on the 4th, 17th day after the start of therapy.
2. Proportion of patients with persistent or worsening signs of infection on the 4th day from the start of treatment, requiring replacement of antibiotic therapy.
3. Assessment of gut microbial community diversity based on the assessment of the variability of 16S genes of ribosomal RNA on the 4th, 17th day from the start of therapy and the 60th day after completion of therapy compared to the initial level.
4. Frequency of adverse events, their severity and relationship with the studied therapy.

Overall trial start date

01/11/2014

Overall trial end date

25/01/2016

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Outpatient patients of both sexes from 3 to 14 years.
2. Established diagnosis of Acute Purulent Sinusitis - evaluation of complaints, anamnesis, temperature, R-picture and rhinoscopy data - pus in the middle nasal passage and/or in the nasopharynx dome.
3. Ability to regularly receive the studied drugs and perform research procedures.
4. The Form of the Written Informed Consent to participate in the study is signed by one of the parents or the legal representative of the patient.
5. Informing the patients' parents that during the entire study period the patient should not take prebiotics, probiotics, synbiotics, sorbents.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Intolerance to azalides, macrolides and other components of the drug.
2. Administration of antibacterial drugs, including sulfonamides, within 28 days before the start of screening.
3. Complicated course of infectious diseases of the upper and lower respiratory tract.
4. Bacterial infection of another location, requiring the administration of antibiotics.
5. Oncological disease without remission, at least for 5 years before the start of the study.
6. Epilepsy, febrile convulsions in history.
7. Impaired immunity according to anamnesis.
8. Immunodeficiency.
9. Active neoplastic process.
10. Any other serious illness or condition that could jeopardize patient safety, affect life expectancy, or hinder successful treatment or monitoring of a patient according to the protocol.
11. The reluctance of the child or his legal representatives to participate in clinical research.
12. Drug use, alcoholism, mental illness of the legal representative of the patient.
13. Participation in other clinical studies of medical drugs less than 3 months before the start of the study.

Recruitment start date

21/04/2015

Recruitment end date

18/11/2015

Locations

Countries of recruitment

Russian Federation

Trial participating centre

Clinical Center 1, Children's City Polyclinic No. 133 of the Department of Health of Moscow
Smolnaya st., 55
Moscow
117997
Russian Federation

Sponsor information

Organisation

OJSC AVVA RUS

Sponsor details

Krylatsky holmy
30
Bldg. 9
Moscow
121614
Russian Federation
+7 (495) 956-75-03
info@avva-rus.ru

Sponsor type

Industry

Website

https://www.avva-rus.ru/

Funders

Funder type

Industry

Funder name

MC Development, Russia.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Anticipated results of the study will be published in peer-review journals within 2019-2020. The microbiome post-treatment profile of the two treatment groups will be analysed and differences and similarities will be characterized. All patient information will remain anonymous.

It is anticipated that the Microbiome profile will be disseminated by publishing the results of the analysis in peer-review journal. No personal patient information will be disclosed but only the bacterial profile will be discussed that cannot be linked to any subject. Data that might be available as supplementary information in our publication will be the operational taxonomic unit (OTUs) that describes the microbiome profile in a given sample.

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication

Intention to publish date

01/04/2019

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes