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Comparative Clinical Trial of Efficiency and Safety of Ergoferon Versus Oseltamivir in Treatment of Influenza

Information source: Materia Medica Holding
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Influenza

Intervention: Ergoferon (Drug); Oseltamivir (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Materia Medica Holding

Overall contact:
Mikhail Putilovskiy, MD, PhD, Phone: +74957836804, Ext: 302, Email: PutilovskiyMA@materiamedica.ru

Summary

The purpose of this study is:

- to assess efficiency of Ergoferon for treatment of influenza;

- to assess safety of Ergoferon for treatment of influenza;

- to compare efficiency of Ergoferon and Oseltamivir for treatment of influenza.

Clinical Details

Official title: Comparative Parallel-group Randomized Clinical Trial of Efficiency and Safety of Ergoferon Versus Oseltamivir in Treatment of Influenza

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Proportion of patient demonstrating recovery/ improvement in health

Secondary outcome:

Dynamics of fever

Average duration of fever

Proportion of patients with normal body temperature (no more than 37.0ºС)

Severity of clinical manifestations of influenza (fever, general symptoms and nasal/ throat/ chest symptoms) in scores

Duration of major clinical symptoms of influenza(fever, general symptoms and nasal/ throat/ chest symptoms) in days

The severity of influenza course

Quantity of antipyretics administration on day 1, 2, 3, 4 and 5 of the treatment

Proportion of patients, who used antipyretics

Proportion of patients with the development of disease complications requiring antibiotics administration, and of patients with exacerbation of the disease course (the development of severe influenza)

Proportion of patients with negative results of virology assay

Dynamics of parameters of immune status

Detailed description: The overall duration of a patient participation in the trial is 6 days

(screening/randomization/therapy onset - day 1; study therapy period - day 1-5; follow-up

period - day 6).

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Patients aged from 18 to 70 years inclusively. 2. Patients, who were admitted to hospital within 48 hours from the onset of influenza signs. 3. Patients with body temperature ≥37,8°C when visiting a doctor + intensity of influenza symptoms ≥4 score (presence of at least 1 general symptom ≥2 scores and 1 nasal/ throat/ chest symptom ≥ 2 scores or greater number of symptoms with the intensity ≥1 score). 4. Diagnosed influenza confirmed by express diagnostics (OSOM Influenza A&B Test). 5. The possibility to start therapy within 48 hours after the onset of the first symptoms of influenza. 6. Usage of contraceptive methods by both gender patients of reproductive age during the trial and within 30 days after ending the participation in the trial. 7. Availability of signed patient information sheet (Informed Consent form) for participation in the clinical trial. Exclusion Criteria: 1. Suspected pneumonia. 2. Suspected initial manifestations of diseases that have symptoms similar to influenza symptoms (other acute respiratory and infectious diseases, influenza-like syndrome at the onset of systemic connective tissue disorders, oncohematology and other pathology). 3. Patients requiring competitive antiviral drugs, which are prohibited during this trial. 4. Medical history of primary and secondary immune deficiency: a) lymphoid system immunodeficiency (T-cell and/or B-cell immunity chain, immunodeficiency with predominant antibody deficiency); b) phagocyte deficiency; c) complement factors deficiency; d) combined immunodeficiency including AIDS induced by HIV infection; toxic, autoimmune, infectious, radial panleukopenia syndrome; general lymphocytopenia syndrome; syndrome of lymphocyte polyclonal activation; postsplenectomia syndrome; congenital asplenia; syndrome of immune complexes pathology associated with infectious, allergic and autoimmune diseases. 5. Medical history of sarcoidosis. 6. Oncological disease/suspected oncological disease. 7. Exacerbation or decompensation of chronic diseases affecting the patient's ability to participate in the clinical trial. 8. Medical history of polyvalent allergy. 9. Allergy/ intolerance to any of the components of medications used in influenza treatment. 10. Impaired glucose tolerance, type 1 and 2 diabetes mellitus. 11. Malabsorption syndrome, including congenital or acquired lactose deficiency or any other disaccharide deficiency. 12. Exacerbation or decompensation of chronic diseases affecting patient's ability to participate in the trial. 13. Pregnancy and breast feeding. 14. Drug addiction, alcohol usage in the amount exceeding 2 units of alcohol per day, mental disorders. 15. Intake of medicines listed in the section "Prohibited concomitant treatment" for 1 month prior to the inclusion in the trial. 16. Patients, who from the investigator's point of view, will fail to comply with the observation requirements of the trial or with the intake regimen of the investigated medicines. 17. Participation in other clinical trials in the course of 1 month prior to the inclusion in the trial. 18. Patient is related to the research personnel of the investigative site, who are directly involved in the trial or are the immediate family member of the researcher. The immediate family members includes husband/wife, parents, children or brothers (or sisters), regardless of whether they are natural or adopted. 19. Patient works for OOO "NPF "Materia Medica Holding" (i. e. is the company's employee, temporary contract worker or appointed official responsible for the carrying out the research) or the immediate relative.

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Locations and Contacts

Mikhail Putilovskiy, MD, PhD, Phone: +74957836804, Ext: 302, Email: PutilovskiyMA@materiamedica.ru

The Non-State Health Care Institution "Road Hospital of the Open Joint Stock Company" Russian Railways", Chelyabinsk 454091, Russian Federation; Recruiting
Yulia Shapovalova, MD PhD
Yulia Shapovalova, MD PhD, Principal Investigator

The State Budgetary Educational Institution of Higher Professional Education " Kazan State University of Medicine" Ministry of Health of the Russian Federation, Kazan 420012, Russian Federation; Not yet recruiting
Rustem Hamitov, MD, PhD, ScD, professor
Rustem Hamitov, MD, PhD, ScD, professor, Principal Investigator

The State Budgetary Educational Institution of Higher Professional Education "Russian National Research Medical University of N.I. Pirogov" Ministry of Health of the Russian Federation, Moscow 117997, Russian Federation; Enrolling by invitation

Federal State Budgetary Military Educational Institution of Higher Professional Education "Military-Medicine Academy named after S. M. Kirov" of Ministry of Defence of Russian Federation, St. Petersburg 194044, Russian Federation; Not yet recruiting
Konstantin Zhdanov, MD, PhD, ScD, Professor
Konstantin Zhdanov, MD, PhD, ScD, Professor, Principal Investigator

St. Petersburg State Budgetary Health Care Institution " City policlinic No. 117", St. Petersburg 194358, Russian Federation; Recruiting
Diana Alpenidze, MD, PhD
Diana Alpenidze, MD, PhD, Principal Investigator

St. Petersburg State Budgetary Health Care Institution " City policlinic No. 117", St. Petersburg 194358, Russian Federation; Enrolling by invitation

St. Petersburg State Budgetary Health Care Institution " Nevsky Region Сity Polyclinic №25", St. Petersburg 193312, Russian Federation; Not yet recruiting
Elena Pavlysh, MD PhD
Elena Pavlysh, MD PhD, Principal Investigator

Additional Information

Starting date: May 2013
Last updated: April 7, 2015

Page last updated: August 23, 2015

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