Clinical Trial of Efficacy and Safety of Ergoferon in the Treatment of Viral Intestinal Infections in Children

NCT03039699 | Completed Phase 4 Results

• 1 other identifier: MMH-ER-008
• Study Type: interventional
• Target: 259
• Locations: 2 countries
• Sites: 13

Brief Summary

The purpose of this study is to obtain additional data on efficacy and safety of Ergoferon in the treatment of viral intestinal infections in inpatient children.

Conditions

Viral Intestinal Infection

Outcome Measures

Primary Outcomes (1)

• Average Diarrhea Duration.

  Diarrhea duration is considered as the time between receiving the first dose of investigational medicine /placebo and the normal consistency of stool pattern (to the previous stool consistency before diarrhea), i.e. 1. time to the first loose stool which is followed by two normal consistency stools over 24 h (infants may have three episodes of loose stool over a 24-hour period), or 2. time to ≤3 episodes of stool occurring over 24 h, at least 2 of which are normal consistency stools, or 3. time to the absence of stools for ≥12 h which is not followed by new episodes of diarrhea (total stool frequency over 24 h - less than 3 times).

  On days 1-10 of observation period.

Secondary Outcomes (7)

• Percentage of Patients Without Diarrhea.

  48, 72 and 96 hours of the treatment.

• Percentage of Patients With Recovery.

  48, 72 and 96 hours of the treatment.

• Average Illness Duration.

  On days 1-10 of observation period.

• Total Clinical Dehydration Scale Score.

  24, 48, and 72 hours of the treatment.

• Average Vomiting Duration (if Any).

  On days 1-10 of observation period.

Study Arms (2)

Ergoferon

EXPERIMENTAL

Tablet for oral use. Dose per administration - 1 tablet per intake (outside a meal/feeding). Within the first 2 hours - 1 tablet every 30 minutes, followed by 3 more tablets at time intervals equally separated throughout the rest of the day; from day 2 to day 5 - 1 tablet 3 times daily.

Drug: Ergoferon

Placebo

PLACEBO COMPARATOR

Tablet for oral use. Dose per administration - 1 tablet per intake (outside a meal/feeding). Within the first 2 hours - 1 tablet every 30 minutes, followed by 3 more tablets at time intervals equally separated throughout the rest of the day; from day 2 to day 5 - 1 tablet 3 times daily.

Drug: Placebo

Interventions

Ergoferon DRUG

Ergoferon

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 6 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients of both gender aged from 6 months to 6 years, who have been admitted to infectious diseases unit.
• Diarrhea (watery diarrhea at least 3 times a day).
• CDS score of ≥1.
• The first 48 hours from the onset of the first diarrhea episode.
• Start of study treatment (Ergoferon/Placebo) within 12 hours after the start of the standard hospital therapy.
• Availability of a patient information sheet (Informed Consent form) signed by the patient's parents/adopters to confirm the child's participation in the clinical trial signed by one parent/adopter of the patient.

You may not qualify if:

• Suspected bacterial intestinal infection.
• Suspected infectious diseases affecting other organ systems (e.g. pneumonia, meningitis, sepsis, otitis media, urinary tract infection, etc.).
• Severe intestinal infection.
• Severe dehydration (CDS score ≥7).
• Anuria (acute kidney injury).
• Medical history or prior diagnosis of serious diseases, including primary/secondary immunodeficiency, oncological disease, diabetes mellitus, infantile cerebral palsy, mucoviscidosis/cystic fibrosis etc.
• Exacerbation, or decompensation of chronic disease, including diseases of the digestive system that would affect the patient's ability to participate in the clinical trial.
• Malabsorption syndrome, including congenital or acquired lactose intolerance/lactase deficiency or any other disaccharidase deficiency and galactosemia.
• Allergy/ intolerance to any of the components of medications used in the treatment.
• Course intake of medicines listed in the section "Prohibited concomitant treatment" for 2 weeks prior to the enrollment in the trial.
• Participation in other clinical trials within 3 months prior to the enrollment in this study.
• Patients whose parents/adopters, from the investigator's point of view, will fail to comply with the observation requirements of the trial or with the dosing regimen of the study drugs.
• Patient's parents/adopters are related to the research staff of the clinical investigative site who are directly involved in the trial or are the immediate family member of the researcher. The immediate family members include husband/wife, parents, children or brothers (or sisters), regardless of whether they are natural or adopted.
• The patient's parent/adopter works for MATERIA MEDICA HOLDING (i.e., is the company's employee, temporary contract worker or appointed official responsible for carrying out the research) or the immediate relative.

Sponsors & Collaborators

• Materia Medica Holding: lead

Study Sites (13)

State budgetary Health Care institution of the Arkhangelsk region "Arkhangelsk Regional Pediatric Clinical Hospital named after PG Vyzhletsova"

Arkhangelsk, 163002, Russia

Location

Federal State Budgetary Educational Institution of Higher Education "Kazan Medical University" of the Ministry of Healthcare of the Russian Federation

Kazan', 420012, Russia

Location

Federal Budget Institution of Science "Central Research Institute of Epidemiology" of The Federal Service on Customers' Rights Protection and Human Well-being Surveillance

Moscow, 111123, Russia

Location

Pirogov Russian National Research Medical University

Moscow, 117997, Russia

Location

Federal State Budgetary Educational Institution of Higher Education "Orenburg State Medical University" of the Ministry of Healthcare of the Russian Federation

Orenburg, 460000, Russia

Location

Municipal Budgetary Health Care Institution "Semashko City Hospital №1 Rostov-on-Don "

Rostov-on-Don, 344000, Russia

Location

Federal State Budgetary Educational Institution of Higher Education "Saint Petersburg State Pediatric Medical University" of the Ministry of Healthcare of the Russian Federation

Saint Petersburg, 194100, Russia

Location

Sailnt Petersburg State Budgetary Health Care Institution "City Child Hospital №22"

Saint Petersburg, 196657, Russia

Location

Federal State Institution "Scientific Research Institute of Children's Infections Federal Biomedical Agency"

Saint Petersburg, 197022, Russia

Location

The State Budget Educational institution of High Professional Training Smolensk State Medical University of Ministry of Health Care of the Russian Federation

Smolensk, 214018, Russia

Location

Federal State Budgetary Educational Institution of Higher Education "Yaroslavl State Medical University" of the Ministry of Healthcare of the Russian Federation

Yaroslavl, 150000, Russia

Location

Federal State Budgetary Institution of Higher Professional Education "Urals State Medical University" of the Ministry of Healthcare of the Russian Federation

Yekaterinburg, 620028, Russia

Location

Scientific Research Institute of Virology of Ministry of Health of Republic Uzbekistan

Tashkent, 100194, Uzbekistan

Location

MeSH Terms

Interventions

ergoferon

Results Point of Contact

• Title: Mikhail Putilovskiy, MD, PhD, Clinical and Medical Department Director
• Organization: Materia Medica Holding

PutilovskiyMA@materiamedica.ru

+74952761571

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2016
• First Posted: February 1, 2017
• Study Start: June 23, 2016
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: October 19, 2020
• Results First Posted: October 19, 2020

Record last verified: 2019-11

Locations

RU (12); UZ (1)