Enterovirus InfectionsNCT00426699
Urinary Excretion of Enteroviruses From Children With a Presumed Enteroviral Infection
An observational study of Enterovirus Infections, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Enteroviruses can infect most human organ systems, especially the heart, nervous system and pancreas. Whether Enteroviruses can also affect the kidneys is not known yet. Therefore we will analyze urine of children with a suspected enteroviral infection for enteroviruses and signs of kidney infection. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Enterovirus Infections
- How many people
- 82 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2006to Nov 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Up to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: children age 0-16
Who may be able to join
- children, suspected of suffering from an enteroviral infection
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Dept. Nephrology & Hypertension, Univ. Hospital Bern
Bern, Canton of Bern, 3010
About this study
Enteroviruses can infect most human organ systems, especially the heart, nervous system and pancreas. Whether Enteroviruses can also affect the kidneys is not known yet. Therefore we will analyze urine of children with a suspected enteroviral infection for enteroviruses and signs of kidney infection.
Read the detailed description
Enteroviruses have been shown to cause mesangioproliferation and glomerulonephritis in mice (especially coxsackievirus B4). In some cases, large amounts of IgA are deposited in the mesangium, resembling human IgA-nephropathy. In humans, case reports indicate the propensity of certain enteroviruses to cause kidney infections.
Our project aims to analyze urine of children with suspected enteroviral infections (e.g. meningitis, myocarditis, sepsis of the newborn etc.) to identify cases suspicious of concomitant enteroviral kidney affection. To achieve this aim, enterovirus-PCRs will be performed and microhematuria searched for.
- Conditions
- Enterovirus Infections
- Keywords
- enterovirus, meningitis, sepsis, myocarditis, kidney, urine, glomerulonephritis
- Medical subject headings
- Enterovirus Infections, Meningitis, Sepsis, Myocarditis, Glomerulonephritis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2007 (estimated)
- Study startJun 2006
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enterovirus InfectionsStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Investigators
- Andreas Pasch, MD, Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00426699
- Sponsor's protocol ID
- BE002
- Status last verified
- May 2011
- First submitted
- 24 Jan 2007
- Last updated
- 19 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Excretion of Enteroviruses From Children With a Presumed Enteroviral Infection
- ClinicalTrials.gov ID
- NCT00426699
- Acronym / sponsor ID
- BE002
- Conditions
- Enterovirus Infections
- Keywords
- enterovirus, meningitis, sepsis, myocarditis, kidney, urine, glomerulonephritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 25 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Enteroviruses can infect most human organ systems, especially the heart, nervous system and pancreas. Whether Enteroviruses can also affect the kidneys is not known yet. Therefore we will analyze urine of children with a suspected enteroviral infection for enteroviruses and signs of kidney infection.
Detailed description
Enteroviruses have been shown to cause mesangioproliferation and glomerulonephritis in mice (especially coxsackievirus B4). In some cases, large amounts of IgA are deposited in the mesangium, resembling human IgA-nephropathy. In humans, case reports indicate the propensity of certain enteroviruses to cause kidney infections.
Our project aims to analyze urine of children with suspected enteroviral infections (e.g. meningitis, myocarditis, sepsis of the newborn etc.) to identify cases suspicious of concomitant enteroviral kidney affection. To achieve this aim, enterovirus-PCRs will be performed and microhematuria searched for.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children age 0-16
Key inclusion criteria (1 listed)
- children, suspected of suffering from an enteroviral infection
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2011.
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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.
Andreas Pasch, MD principal investigator
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Enterovirus Infections, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 1 inclusion and 0 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 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 May 2011.