Study on Safety and Effectiveness of Ergoferon in the Treatment of Influenza/Acute Viral URI in Outpatients.
Keywords
Abstract
Description
This observational study is aimed to provide additional safety and effectiveness data for Ergoferon in the treatment of influenza/acute viral URI in adult and pediatric outpatients, including cases with delayed treatment initiation (after 48 or 72 h of the onset of illness), and in allergy patients. Routine clinical practice in the management of outpatients with acute viral URI is to be studied in Azerbaijan, Armenia, Georgia, Kazakhstan, Kyrgyzstan, Mongolia, Tajikistan and Uzbekistan: the demographic characteristics of patients, duration and time points of treatment with the use of Ergoferon, its safety, and the frequency of additional medication.
Scope of the study: 519 general practitioners; 8411 patients. Physical examinations and tests are performed according to local outpatient clinical practice, and to local and international medical care standards.
Data to be collected and analyzed after the completion of treatment:
- demographics (age, gender, and city/town of residence)
- severity of illness (mild, moderate, or severe)
- comorbidities (chronic ENT conditions, chronic obstructive pulmonary disease (COPD), chronic cardiovascular disease, allergic rhinitis/sinusitis, atopic dermatitis/eczema, asthma, or other)
- the time of resolution of infection symptoms (absence of fever - a body temperature below 37.0°С), systemic symptoms (chills, headaches, myalgias, weakness, and loss of appetite), nasal symptoms (nasal congestion/ discharge), laryngeal symptoms (a sore throat, or other), and other symptoms
- illness time points: onset of illness, first visit to the doctor's office, and start of treatment.
- symptomatic therapy (drug name, date prescribed, and date discontinued)
- therapy for bacterial complications (date the antimicrobial drug is prescribed, drug name, diagnosis, hospitalization or no hospitalization required, date of hospitalization)
- adverse events (description of the event, causality (related/ not related to Ergoferon), severity, date of the onset, and actions taken)
- efficacy assessment of the Ergoferon treatment (high efficacy: recovery / satisfactory: improvement/ insufficient: no effect) - observational study model: cohort, a cohort study is an observation of outcomes in a group of individuals linked by shared characteristics (an acute viral URI and use of Ergoferon).
Dates
| Last Verified: | 04/30/2020 |
| First Submitted: | 05/24/2020 |
| Estimated Enrollment Submitted: | 06/01/2020 |
| First Posted: | 06/03/2020 |
| Last Update Submitted: | 06/01/2020 |
| Last Update Posted: | 06/03/2020 |
| Actual Study Start Date: | 09/30/2016 |
| Estimated Primary Completion Date: | 03/31/2017 |
| Estimated Study Completion Date: | 03/31/2017 |
Condition or disease
Intervention/treatment
Drug: Ergoferon
Phase
Eligibility Criteria
| Ages Eligible for Study | 6 Months To 6 Months |
| Sexes Eligible for Study | All |
| Sampling method | Non-Probability Sample |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - Children from 6 months to 18 years old and adults over 18 years old. - Diagnosis: Flu / ARVI. - Axillary temperature above 37.4 °С. - At least one systemic and/or catarrhal symptom lasting 12 hours to 3 days by the time the doctor is consulted, for which treatment with Ergoferon is prescribed. - A specific decision of the doctor to prescribe Ergoferon in strict accordance with the indications, regardless of the factor of including patient data in the program. - CRF, filled by a doctor on the basis of medical documentation, at the end of patient observation. Exclusion Criteria: - |
Outcome
Primary Outcome Measures
1. Duration of influenza/acute viral URI symptoms. [through study completion up to 1 month]
Secondary Outcome Measures
1. Duration of increased body temperature. [through study completion up to 1 month]
2. Duration of systemic symptoms. [through study completion up to 1 month]
3. Duration of nose symptoms. [through study completion up to 1 month]
4. Duration of throat symptoms. [through study completion up to 1 month]
5. Percentage of patients with complications of influenza/acute viral URI. [through study completion up to 1 month]
