Study on Safety and Effectiveness of Ergoferon in the Treatment of Flu / ARVI in Outpatients.

Viral Respiratory Infection Clinical Trial

— HERMITAGE  

Official title:

International Observational Non-Interventional Retrospective Program for Studying the Efficiency and Safety of Ergoferon in Patients With Influenza and Acute Respiratory Viral Infection (ARVI).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04413929
• Other study ID #: HERMITAGE
• Status: Completed
• Start date: October 2016
• Est. completion date: April 2017

Study information

• Verified date: May 2020
• Source: Materia Medica Holding
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The observational study to get the additional data of the safety and effectiveness of Ergoferon in the treatment of influenza/ARVI in adult and pediatric outpatients.

Description:

This observational study is aimed to provide additional safety and effectiveness data for Ergoferon in the treatment of influenza/ARVI in adult and pediatric outpatients, including cases with delayed treatment initiation of illness, and in allergy patients. Routine clinical practice in the management of outpatients with ARVI 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)

• serious 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 Cohort study is an observation of outcomes in a group of individuals linked by shared characteristics (an acute respiratory viral infections and use of Ergoferon).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8411
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 75 Years

Eligibility

Inclusion Criteria:

• Data of children from 6 months to 18 years old and adults over 18 years old.

• Diagnosis: Flu / ARVI.

• Axillary temperature above 37.4 °?.

• 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:

Not applicable.

Related Conditions & MeSH terms

• Infection
• Respiratory Tract Infections
• Viral Respiratory Infection

Intervention

Drug:
• Ergoferon
Oral administration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Materia Medica Holding

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of Influenza/ARVI Symptoms.	The time from the onset of treatment with Ergoferon to the resolution of the symptoms, i.e. a body temperature =37.0 °? remaining at this level for 24 h (with no further increases throughout the rest of the observation period) in the absence of catarrhal signs and systemic symptoms. Based on Case Report Form data.	through study completion up to 1 month
Secondary	Duration of Increased Body Temperature.	A body temperature =37.0 °?. Based on Case Report Form data.	through study completion up to 1 month
Secondary	Duration of Systemic Symptoms.	Symptoms of intoxication (chills, headache, muscle pain, weakness, loss of appetite).; Based on Case Report Form data.	through study completion up to 1 month
Secondary	Duration of Nose Symptoms.	Symptoms of the nose (nasal congestion, discharge from the nose), other symptoms. Based on Case Report Form data.	through study completion up to 1 month
Secondary	Duration of Throat Symptoms.	Symptoms of the throat (sore throat, etc.). Based on Case Report Form data.	through study completion up to 1 month
Secondary	Percentage of Patients With Complications of Influenza/Acute Viral URI.	Patients who got bacterial complications of influenza/acute viral URI, requiring the antibiotics and/or hospitalization during the observation period.	through study completion up to 1 month