Viral Intestinal InfectionPhase 4NCT03039699
Clinical Trial of Efficacy and Safety of Ergoferon in the Treatment of Viral Intestinal Infections in Children
A Phase 4 study testing Ergoferon in people with Viral Intestinal Infection, run by Materia Medica Holding at 13 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 6 years
- Conditions the study is for
- Viral Intestinal Infection
- What is being tested?
- Ergoferon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 259 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 23 Jun 2016to 1 Jun 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
Russia12 sites
State budgetary Health Care institution of the Arkhangelsk region "Arkhangelsk Regional Pediatric Clinical Hospital named after PG Vyzhletsova"
Arkhangelsk, 163002
Federal State Budgetary Educational Institution of Higher Education "Kazan Medical University" of the Ministry of Healthcare of the Russian Federation
Kazan', 420012
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
Pirogov Russian National Research Medical University
Moscow, 117997
Federal State Budgetary Educational Institution of Higher Education "Orenburg State Medical University" of the Ministry of Healthcare of the Russian Federation
Orenburg, 460000
Municipal Budgetary Health Care Institution "Semashko City Hospital №1 Rostov-on-Don "
Rostov-on-Don, 344000
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
Sailnt Petersburg State Budgetary Health Care Institution "City Child Hospital №22"
Saint Petersburg, 196657
Federal State Institution "Scientific Research Institute of Children's Infections Federal Biomedical Agency"
Saint Petersburg, 197022
The State Budget Educational institution of High Professional Training Smolensk State Medical University of Ministry of Health Care of the Russian Federation
Smolensk, 214018
Federal State Budgetary Educational Institution of Higher Education "Yaroslavl State Medical University" of the Ministry of Healthcare of the Russian Federation
Yaroslavl, 150000
Federal State Budgetary Institution of Higher Professional Education "Urals State Medical University" of the Ministry of Healthcare of the Russian Federation
Yekaterinburg, 620028
Uzbekistan1 site
Scientific Research Institute of Virology of Ministry of Health of Republic Uzbekistan
Tashkent, 100194
About this study
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
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.
Read the detailed description
Design: a multicenter, double-blind, placebo-controlled, randomized clinical trial in parallel groups.
This study will enroll subjects of both sexes aged from 6 months to 6 years who are admitted to hospital within 48 h of the onset of acute intestinal infection (AII), presumably of viral aetiology. Patients to be enrolled in the screening will be children with typical viral gastroenteritis/enteritis symptoms. The key symptom is decreased in the consistency of stools (loose or liquid) and increased in the frequency of its evacuations (at list 3 time daily). Virus detection in stool samples will be performed by polymerase chain reaction (PCR).
After the parent/adopter signs a parents/adopters information sheet (Informed Consent form) for the child's participation in the clinical trial, the recording of medical history data, a medical examination including the evaluation of symptoms on the Clinical Dehydration Scale (CDS) by pediatrician, and laboratory tests will be performed during Visit 1 (Day 1). If inclusion criteria are met and non-inclusion criteria are absent (day 1), the patient will be included in the trial and randomized to administer either Ergoferon or Placebo.
In addition to the standard/pathogenetic therapies, group 1 patients will take Ergoferon following a 5-day regimen, whereas group 2 patients will receive Placebo. The parents/adopters of the patient will be provided with a patient diary and instructed how to complete the diary.
Before treatment stool specimens will be collected from the patients for detection and differentiation of Rotavirus A, Norovirus 2 genotype, Astrovirus, Adenovirus F, Shigella spp., enteroinvasive E.coli (EIEC), Salmonella spp., and thermophilic Campylobacter spp. using a PCR assay to diagnose the etiology of intestinal infection. In total, the patients will be monitored for 10 days (screening, randomization, treatment initiation - Day 1; the treatment on Days 1-5; observation in hospital - Day 6, and follow-up period - Day 7-10). During the treatment and inpatient observation periods (Days 1-6, Visits 1-6), the patients will be examined daily by a pediatrician, and the examination results, including the CDS scores, will be recorded in source documents. The patient's parent/adopter will complete the patient diary every day, recording the presence/absence of diarrhea signs, vomiting, and body temperature. The pediatrician will check them each time for the correctness of completion. On day 10 (after hospital discharge), Visit 7 will be done (as an in-person visit (a hospital or calling a doctor) or a distance, 'phone' visit) to interview the parents/adopters about the patient's health, presence of any complications, and use of medications (the pediatrician will use this information to complete a questionnaire). Collection of stool specimens and repeat PCR for Rotaviruses/Noroviruses/Astroviruses/Adenoviruses, Shigella spp., EIEC, Salmonella spp., and Campylobacter spp. will be performed on Days 3, 4, and 6 of inpatient observation and after discharge from the hospital (Day 10); collection of blood and urine specimens for safety tests will be carried out at baseline and before hospital discharge (day 6). The recording of the intake of study therapies and of concomitant medications as well as the assessment of compliance with and safety of the study therapies will be performed on Days 2-6 and 10.
Patients who recovered while in hospital and are discharged from the unit earlier than at 5 days will undergo the procedures of Visit 6, including the collection of biological specimens for PCR (efficacy evaluation) and biochemistry, blood test and urinalysis (safety assessment). The parents/adopters will be given the blister pack with the remaining study drug so that the patient can continue the treatment.
- Conditions
- Viral Intestinal Infection
- Being tested
- Ergoferon, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErgoferonDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- 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
- time to ≤3 episodes of stool occurring over 24 h, at least 2 of which are normal consistency stools, or
- 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).
Measured: On days 1-10 of observation period.
Secondary outcomes (7)
Percentage of Patients Without Diarrhea.
Based on medical records.
Measured: 48, 72 and 96 hours of the treatment.
Percentage of Patients With Recovery.
Based on medical records. Recovery criteria: absence of diarrhea, vomiting, symptoms of dehydration, and increased body temperature (based on daily examinations by pediatrician).
Measured: 48, 72 and 96 hours of the treatment.
Average Illness Duration.
From the enrollment to the recovery. Recovery criteria: absence of diarrhea, vomiting, symptoms of dehydration, and increased body temperature (based on daily examinations by pediatrician).
Measured: On days 1-10 of observation period.
Total Clinical Dehydration Scale Score.
Based on medical records. Clinical Dehydration Scale score is more or equal 1. Note: minimum values - 0 points, maximum values - 8 points. Interpretation: 0 points - no dehydration, from 1 to 4 points - light dehydration, 5-8 points - average/severe dehydration.
Measured: 24, 48, and 72 hours of the treatment.
Average Vomiting Duration (if Any).
Based on medical records.
Measured: On days 1-10 of observation period.
Percentage of Patients With Negative PCR Tests.
Based on medical records.
Measured: On days 3, 4, 6 and 10 of observation period.
Percentage of Patients With Worsening of Illness and/or Hospital-acquired Infection.
Based on medical records. Worsening of illness: an increase in dehydration scores and worsening of non-specific symptoms, as evidenced by a decline in general appearance, increasing fatigue and drowsiness, refusal to eat and drink, severe tachycardia/bradycardia, unstable hemodynamics, tachypnea, hypo- or hyperventilation, circulation disorders, peripheral cyanosis, sunken eyes, severe dryness of skin and mucous/tongue, poor tissue turgor, absent tears, persistent vomiting, anuria/acute kidney injury, seizure/convulsions, and meningismus. Hospital-acquired infection: a viral or bacterial infection (intestinal, respiratory or urinary tract infection, etc.) occurring after at least 48 h of hospital stay and confirmed by laboratory tests.
Measured: On days 1-10 of observation period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study start23 Jun 2016
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Viral Intestinal InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 259 participants (actual)
Sponsor and investigators
- Lead sponsor
- Materia Medica Holding
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03039699
- Sponsor's protocol ID
- MMH-ER-008
- Status last verified
- Nov 2019
- First submitted
- 28 Dec 2016
- Last updated
- 19 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03039699
- Acronym / sponsor ID
- MMH-ER-008
- Conditions
- Viral Intestinal Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 259 participants (actual)
- Lead sponsor
- Materia Medica HoldingIndustry (pharma, biotech, devices)
- Study start
- 23 Jun 2016 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 1 Feb 2017 (estimated)
- Results
- Posted 19 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Design: a multicenter, double-blind, placebo-controlled, randomized clinical trial in parallel groups.
This study will enroll subjects of both sexes aged from 6 months to 6 years who are admitted to hospital within 48 h of the onset of acute intestinal infection (AII), presumably of viral aetiology. Patients to be enrolled in the screening will be children with typical viral gastroenteritis/enteritis symptoms. The key symptom is decreased in the consistency of stools (loose or liquid) and increased in the frequency of its evacuations (at list 3 time daily). Virus detection in stool samples will be performed by polymerase chain reaction (PCR).
After the parent/adopter signs a parents/adopters information sheet (Informed Consent form) for the child's participation in the clinical trial, the recording of medical history data, a medical examination including the evaluation of symptoms on the Clinical Dehydration Scale (CDS) by pediatrician, and laboratory tests will be performed during Visit 1 (Day 1). If inclusion criteria are met and non-inclusion criteria are absent (day 1), the patient will be included in the trial and randomized to administer either Ergoferon or Placebo.
In addition to the standard/pathogenetic therapies, group 1 patients will take Ergoferon following a 5-day regimen, whereas group 2 patients will receive Placebo. The parents/adopters of the patient will be provided with a patient diary and instructed how to complete the diary.
Before treatment stool specimens will be collected from the patients for detection and differentiation of Rotavirus A, Norovirus 2 genotype, Astrovirus, Adenovirus F, Shigella spp., enteroinvasive E.coli (EIEC), Salmonella spp., and thermophilic Campylobacter spp. using a PCR assay to diagnose the etiology of intestinal infection. In total, the patients will be monitored for 10 days (screening, randomization, treatment initiation - Day 1; the treatment on Days 1-5; observation in hospital - Day 6, and follow-up period - Day 7-10). During the treatment and inpatient observation periods (Days 1-6, Visits 1-6), the patients will be examined daily by a pediatrician, and the examination results, including the CDS scores, will be recorded in source documents. The patient's parent/adopter will complete the patient diary every day, recording the presence/absence of diarrhea signs, vomiting, and body temperature. The pediatrician will check them each time for the correctness of completion. On day 10 (after hospital discharge), Visit 7 will be done (as an in-person visit (a hospital or calling a doctor) or a distance, 'phone' visit) to interview the parents/adopters about the patient's health, presence of any complications, and use of medications (the pediatrician will use this information to complete a questionnaire). Collection of stool specimens and repeat PCR for Rotaviruses/Noroviruses/Astroviruses/Adenoviruses, Shigella spp., EIEC, Salmonella spp., and Campylobacter spp. will be performed on Days 3, 4, and 6 of inpatient observation and after discharge from the hospital (Day 10); collection of blood and urine specimens for safety tests will be carried out at baseline and before hospital discharge (day 6). The recording of the intake of study therapies and of concomitant medications as well as the assessment of compliance with and safety of the study therapies will be performed on Days 2-6 and 10.
Patients who recovered while in hospital and are discharged from the unit earlier than at 5 days will undergo the procedures of Visit 6, including the collection of biological specimens for PCR (efficacy evaluation) and biochemistry, blood test and urinalysis (safety assessment). The parents/adopters will be given the blister pack with the remaining study drug so that the patient can continue the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ergoferon | Experimental | Drug: ErgoferonTablet 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. |
| Placebo | Placebo comparator | Drug: PlaceboTablet 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. |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ergoferon | Drug | Ergoferon |
| Placebo | Drug | Placebo |
Primary outcome
Average Diarrhea Duration.
Time frame: On days 1-10 of observation period.
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).
7 secondary outcomes
Percentage of Patients Without Diarrhea.
Time frame: 48, 72 and 96 hours of the treatment.
Percentage of Patients With Recovery.
Time frame: 48, 72 and 96 hours of the treatment.
Average Illness Duration.
Time frame: On days 1-10 of observation period.
Total Clinical Dehydration Scale Score.
Time frame: 24, 48, and 72 hours of the treatment.
Average Vomiting Duration (if Any).
Time frame: On days 1-10 of observation period.
Percentage of Patients With Negative PCR Tests.
Time frame: On days 3, 4, 6 and 10 of observation period.
Percentage of Patients With Worsening of Illness and/or Hospital-acquired Infection.
Time frame: On days 1-10 of observation period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ergoferon in people with Viral Intestinal Infection, run by Materia Medica Holding at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Russia, Uzbekistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Diarrhea Duration. (time frame: On days 1-10 of observation period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.