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

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ClinicalTrials.gov Identifier: NCT03039699
Recruitment Status : Recruiting
First Posted : February 1, 2017
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Materia Medica Holding

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

Condition or disease Intervention/treatment Phase
Viral Intestinal Infection Drug: Ergoferon Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 286 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: International Multicenter, Double-blind, Randomized, Parallel Group Placebo-Controlled Clinical Trial of Efficacy and Safety of Ergoferon in the Treatment of Viral Intestinal Infections in Children
Actual Study Start Date : June 23, 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ergoferon
1 tablet 3 times a day
Drug: Ergoferon
Placebo Comparator: Placebo
1 tablet 3 times a day
Drug: Placebo



Primary Outcome Measures :
  1. Average diarrhea duration [ Time Frame: From the time of randomization until the time of normal stool (normal consistency and normal frequency), assessed up to 14 days ]

Secondary Outcome Measures :
  1. Percentage of patients without diarrhea [ Time Frame: Study entry, 48, 72, and 96 hours ]
  2. Percentage of patients with recovery [ Time Frame: Study entry, 48, 72, and 96 hours ]
  3. Average illness duration [ Time Frame: From the time of randomization until the time of alleviation of all symptoms, assessed up to 14 days ]
  4. Total CDS score [ Time Frame: Study entry, 24, 48, and 72 hours ]
  5. Average vomiting duration [ Time Frame: From the time of randomization until the time of vomiting absence, assessed up to 14 days ]
  6. Percentage of patients with negative PCR tests [ Time Frame: Study entry, 3, 4, 5, and 10 days ]
  7. Percentage of patients with worsening of illness and/or hospital-acquired infection [ Time Frame: From the time of randomization up to 14 days ]


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Ages Eligible for Study:   6 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients of both sexes aged from 6 months to 6 years, who have been admitted to hospital infectious diseases unit.
  2. Diarrhea (watery diarrhea at least 3 times a day).
  3. CDS score of ≥1.
  4. The first 48 hours from the onset of the first diarrhea episode.
  5. Start of study treatment (Ergoferon/Placebo) within 12 hours after the start of the standard hospital therapy.
  6. 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 patient.

Exclusion Criteria:

  1. Suspected bacterial intestinal infection.
  2. Suspected infectious diseases affecting other organ systems (e.g. pneumonia, meningitis, sepsis, otitis media, urinary tract infection, etc.).
  3. Severe intestinal infection .
  4. Severe dehydration (CDS score ≥7).
  5. Anuria (acute kidney injury).
  6. Medical history or prior diagnosis of serious diseases, including primary/secondary immunodeficient, oncological disease, diabetes mellitus, infantile cerebral palsy, mucoviscidosis/cystic fibrosis etc.
  7. Exacerbation or decompensation of a chronic disease, including diseases of the digestive system that would affect the patient's ability to participate in the clinical trial.
  8. Malabsorption syndrome, including congenital or acquired lactose intolerance/lactase deficiency or any other disaccharidase deficiency and galactosemia.
  9. Allergy/ intolerance to any of the components of medications used in the treatment.
  10. Course intake of medicines listed in the section "Prohibited concomitant treatment" for 2 weeks prior to the enrollment in the trial.
  11. Participation in other clinical trials within 3 months prior to the enrollment in this study.
  12. Patients whose parents/adopters, from 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.
  13. 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.
  14. The patient's parent/adopter works for OOO "NPF "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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03039699


Contacts
Contact: Mikhail Putilovskiy, MD +74952761571 ext 302 PutilovskiyMA@materiamedica.ru

Locations
Russian Federation
State budgetary health care institution of the Arkhangelsk region "Arkhangelsk Regional Pediatric Clinical Hospital named after PG Vyzhletsova" Recruiting
Arkhangel'sk, Russian Federation, 163002
Contact: Olga Samodova, MD, PhD         
Principal Investigator: Olga Samodova, MD, PhD         
Federal State Budgetary Institution of Higher Professional Education "Urals State Medical University" of the Ministry of Healthcare of the Russian Federation Completed
Ekaterinburg, Russian Federation, 620028
Federal State Budgetary Educational Institution of Higher Education "Kazan Medical University" of the Ministry of Healthcare of the Russian Federation Completed
Kazan', Russian Federation, 420012
Federal Budget Institution of Science "Central Research Institute of Epidemiology" of The Federal Service on Customers' Rights Protection and Human Well-being Surveillance Completed
Moscow, Russian Federation, 111123
Pirogov Russian National Research Medical University Not yet recruiting
Moscow, Russian Federation, 117997
Contact: Nadezhda Zvereva, MD, PhD         
Principal Investigator: Nadezhda Zvereva, MD, PhD         
Federal State Budgetary Educational Institution of Higher Education "Orenburg State Medical University" of the Ministry of Healthcare of the Russian Federation Completed
Orenburg, Russian Federation, 460000
Municipal Budgetary Health Care Institutions "Semashko City Hospital №1 Rostov-on-Don " Completed
Rostov-on-Don, Russian Federation, 344000
Federal State Budgetary Educational Institution of Higher Education "Saint Petersburg State Pediatric Medical University" of the Ministry of Healthcare of the Russian Federation Not yet recruiting
Saint Petersburg, Russian Federation, 194100
Contact: Vladimir Timchenko, MD, PhD         
Principal Investigator: Vladimir Timchenko, MD, PhD         
Sailnt Petersburg State Budgetary Health Care Institution "City Child Hospital №22" Recruiting
Saint Petersburg, Russian Federation, 196657
Contact: Marina Koshchavceva, MD         
Principal Investigator: Marina Koshchavceva, MD         
Federal State Institution "Scientific Research Institute of Children's Infections Federal Biomedical Agency" Recruiting
Saint Petersburg, Russian Federation, 197022
Contact: Yurij Lobzin, MD, PhD         
Principal Investigator: Yurij Lobzin, MD, PhD         
The State Budget Educational institution of High Professional Training Smolensk State Medical University of Ministry of Health Care of the Russian Federation Recruiting
Smolensk, Russian Federation, 214018
Contact: Antonina Grekova, MD         
Principal Investigator: Antonina Grekova, MD         
Federal State Budgetary Educational Institutionof Higher Education "Yaroslavl State Medical University" of the Ministry of Healthcare of the Russian Federation Suspended
Yaroslavl, Russian Federation, 150000
Uzbekistan
Scientific Research Institute of Virology of Ministry of Health of Republic Uzbekistan Completed
Tashkent, Uzbekistan, 100194
Sponsors and Collaborators
Materia Medica Holding

Responsible Party: Materia Medica Holding
ClinicalTrials.gov Identifier: NCT03039699     History of Changes
Other Study ID Numbers: MMH-ER-008
First Posted: February 1, 2017    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Infection
Communicable Diseases
Trematode Infections
Helminthiasis
Parasitic Diseases