Treatment of nasal inflammation in children using azithromycin alone or combined with lactulose.

Phase 4

Completed

• Conditions: Rhinosinusitis in children; Respiratory

• Registration Number: ISRCTN14790675
• Lead Sponsor: OJSC AVVA RUS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-01-25
• Study Start: 2019-02-22
• Last Update Posted: 18 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified