deltatrials
Unknown OBSERVATIONAL NCT02662543

The Epidemiology and Etiology of Acute Gastroenteritis Among Estonian Children After Introduction of Rotavirus Vaccines (ERVS)

The Epidemiology and Etiology of Acute Gastroenteritis Among Estonian Children Aged < 18 Years After Introduction of Rotavirus Vaccines

Sponsor: University of Tartu

Updated 12 times since 2017 Last updated: Dec 20, 2016 Started: Feb 28, 2015 Primary completion: Aug 31, 2018 Completion: Aug 31, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A observational or N/A phase clinical study on Rotavirus Infection, this trial is ongoing. The trial is conducted by University of Tartu and has accumulated 12 data snapshots since 2015. Infectious disease trials contribute critical data for public health response and treatment development.

Study Description(click to expand)

The two-year study period started in February 2015. The study population consists of all children less than 18-years-old hospitalized due to acute gastroenteritis (AGE) to seven Estonian hospitals participating in this study. Expected sample size is about 2000 patients. Hospitals that participate in this study are Tartu University Hospital, West-Tallinn Central Hospital, Tallinn's Children Hospital, Pärnu Central Hospital, South-Estonian Hospital, Kuressaare Hospital and Ida-Viru Central Hospital. Before enrollment all patients are asked to give an informed consent. After enrollment the study doctor completes electronic questionnaire regarding the patients demographic data, medical history and vaccinations. Specific database for our study has been created by company Vision 5D. After completing electronic questionnaire the doctor collects 2 stool samples each 2 ml of volume into Eppendorf tubes produced by our study laboratory. The samples are transported to our study laboratory where they are tested for rotavirus, norovirus G1, G2, astrovirus, adenovirus and sapovirus with Fast-Track Diagnostics real-time assay kit FTD Viral Gastroenteritis. The samples positive for rotavirus are refrigerated at -70 degrees for further genotyping and sequencing.

The two-year study period started in February 2015.

The study population consists of all children less than 18-years-old hospitalized due to acute gastroenteritis (AGE) to seven Estonian hospitals participating in this study. Expected sample size is about 2000 patients.

Hospitals that participate in this study are Tartu University Hospital, West-Tallinn Central Hospital, Tallinn's Children Hospital, Pärnu Central Hospital, South-Estonian Hospital, Kuressaare Hospital and Ida-Viru Central Hospital.

Before enrollment all patients are asked to give an informed consent. After enrollment the study doctor completes electronic questionnaire regarding the patients demographic data, medical history and vaccinations. Specific database for our study has been created by company Vision 5D. After completing electronic questionnaire the doctor collects 2 stool samples each 2 ml of volume into Eppendorf tubes produced by our study laboratory. The samples are transported to our study laboratory where they are tested for rotavirus, norovirus G1, G2, astrovirus, adenovirus and sapovirus with Fast-Track Diagnostics real-time assay kit FTD Viral Gastroenteritis. The samples positive for rotavirus are refrigerated at -70 degrees for further genotyping and sequencing.

Status Flow

~Jan 2017 – ~Aug 2017 · 7 months · monthly snapshotActive Not Recruiting~Aug 2017 – ~Apr 2018 · 8 months · monthly snapshotActive Not Recruiting~Apr 2018 – ~May 2018 · 30 days · monthly snapshotActive Not Recruiting~May 2018 – ~Jun 2018 · 31 days · monthly snapshotActive Not Recruiting~Jun 2018 – ~Sep 2020 · 27 months · monthly snapshotActive Not Recruiting~Sep 2020 – ~Nov 2020 · 2 months · monthly snapshotUnknown Status~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshotUnknown Status~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshotUnknown Status~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshotUnknown Status~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotUnknown~Sep 2024 – present · 19 months · monthly snapshotUnknown~Jan 2026 – present · 3 months · monthly snapshotUnknown

Change History

12 versions recorded
  1. Jan 2026 — Present [monthly]

    Unknown

  2. Sep 2024 — Present [monthly]

    Unknown

  3. Jul 2024 — Sep 2024 [monthly]

    Unknown

    Status: Unknown StatusUnknown

  4. Dec 2021 — Jul 2024 [monthly]

    Unknown Status

  5. Jan 2021 — Dec 2021 [monthly]

    Unknown Status

Show 7 earlier versions
  1. Nov 2020 — Jan 2021 [monthly]

    Unknown Status

  2. Sep 2020 — Nov 2020 [monthly]

    Unknown Status

    Status: Active Not RecruitingUnknown Status

  3. Jun 2018 — Sep 2020 [monthly]

    Active Not Recruiting

  4. May 2018 — Jun 2018 [monthly]

    Active Not Recruiting

  5. Apr 2018 — May 2018 [monthly]

    Active Not Recruiting

    Phase: NANone

  6. Aug 2017 — Apr 2018 [monthly]

    Active Not Recruiting NA

  7. Jan 2017 — Aug 2017 [monthly]

    Active Not Recruiting NA

    First recorded

Feb 2015

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • University of Tartu
Data source: University of Tartu

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations