Rhinosinusitis in children Respiratory
Conditions
Interventions
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 a
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).
Sponsors
OJSC AVVA RUS
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Russian Federation
Outcome results
None listed