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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03039699 |
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Date of registration:
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28/12/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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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 |
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Date of first enrolment:
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June 23, 2016 |
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Target sample size:
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259 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03039699 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Russian Federation
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Uzbekistan
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Patients of both gender aged from 6 months to 6 years, who have been admitted to
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 the 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
immunodeficiency, oncological disease, diabetes mellitus, infantile cerebral palsy,
mucoviscidosis/cystic fibrosis etc.
7. 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.
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 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.
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 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.
Age minimum:
6 Months
Age maximum:
6 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Viral Intestinal Infection
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Intervention(s)
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Drug: Ergoferon
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Drug: Placebo
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Primary Outcome(s)
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Average Diarrhea Duration.
[Time Frame: On days 1-10 of observation period.]
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Secondary Outcome(s)
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Percentage of Patients With Negative PCR Tests.
[Time Frame: On days 3, 4, 6 and 10 of observation period.]
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Total Clinical Dehydration Scale Score.
[Time Frame: 24, 48, and 72 hours of the treatment.]
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Average Illness Duration.
[Time Frame: On days 1-10 of observation period.]
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Percentage of Patients With Worsening of Illness and/or Hospital-acquired Infection.
[Time Frame: On days 1-10 of observation period.]
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Percentage of Patients With Recovery.
[Time Frame: 48, 72 and 96 hours of the treatment.]
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Percentage of Patients Without Diarrhea.
[Time Frame: 48, 72 and 96 hours of the treatment.]
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Average Vomiting Duration (if Any).
[Time Frame: On days 1-10 of observation period.]
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Secondary ID(s)
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MMH-ER-008
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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