Infection ViralCagableaNCT05041764
RNA Sequencing of Individual Versus Wastewater - SARS-CoV2
An observational study of Infection Viral, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
Trial summary
The aim is to compare the percentage of the different SARS-CoV2 lineages that are detected in wastewater samples with matched clinical samples. About 1,400 swab samples from patients living in Nice were tested by Biogroup between Oct 19th and Oct 23rd (Week 43 of 2020). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infection Viral
- How many people
- 1,409 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Oct 2020to 1 Nov 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: nice population
Who may be able to join
- whole population tested in Nice during W43 of 2020
Who cannot join
- none
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Comparison Between Individual and Wastewater SARS-CoV2 RNA Sequencing
The aim is to compare the percentage of the different SARS-CoV2 lineages that are detected in wastewater samples with matched clinical samples. About 1,400 swab samples from patients living in Nice were tested by Biogroup between Oct 19th and Oct 23rd (Week 43 of 2020). The sequence of 81 PCR positive samples, corresponding to all samples that were unambiguously assigned to one of the wastewater catchment areas and their lineage was determined. These values were compared to values measured in wastewater.
- Conditions
- Infection Viral
- Being tested
- NO INTERVENTION
- Medical subject headings
- Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NO INTERVENTIONOther
No INTERVENTION
| Study group | Role | What they receive |
|---|---|---|
| PCR positive | samples that are positive for the detection of SARS-CoV2. The SARS-CoV2 sequence of positive samples is provided, together with an indication about patient's neigborhood, corresponding to one of the 21 different spots which wastewater was analyzed Receives: Other: NO INTERVENTION | |
| PCR negative | samples that are p negative for the detection of SARS-CoV2. T Receives: Other: NO INTERVENTION |
What is being measured
The primary outcome is the main question the study is designed to answer.
RTqPCR result
positive ou negative result to SAR-Cov2
Measured: 1 month
SARS-CoV2 sequence
analyse of SARS-CoV2 sequence (in the case of positive samples)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start1 Oct 2020
- Primary completion1 Nov 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection ViralStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,409 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041764
- Sponsor's protocol ID
- 21DSP-IPMC01
- Acronym
- Cagablea
- Status last verified
- Sep 2021
- First submitted
- 3 Sep 2021
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Individual and Wastewater SARS-CoV2 RNA Sequencing
- ClinicalTrials.gov ID
- NCT05041764
- Acronym / sponsor ID
- Cagablea / 21DSP-IPMC01
- Conditions
- Infection Viral
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,409 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 13 Sep 2021 (actual)
- 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.
The aim is to compare the percentage of the different SARS-CoV2 lineages that are detected in wastewater samples with matched clinical samples. About 1,400 swab samples from patients living in Nice were tested by Biogroup between Oct 19th and Oct 23rd (Week 43 of 2020). The sequence of 81 PCR positive samples, corresponding to all samples that were unambiguously assigned to one of the wastewater catchment areas and their lineage was determined. These values were compared to values measured in wastewater.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCR positive | – | Other: NO INTERVENTIONsamples that are positive for the detection of SARS-CoV2. The SARS-CoV2 sequence of positive samples is provided, together with an indication about patient's neigborhood, corresponding to one of the 21 different spots which wastewater was analyzed |
| PCR negative | – | Other: NO INTERVENTIONsamples that are p negative for the detection of SARS-CoV2. T |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- nice population
Key inclusion criteria (1 listed)
- whole population tested in Nice during W43 of 2020
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| NO INTERVENTIONNo INTERVENTION | Other | PCR negative, PCR positive |
Primary outcome
RTqPCR result
Time frame: 1 month
positive ou negative result to SAR-Cov2
SARS-CoV2 sequence
Time frame: 1 month
analyse of SARS-CoV2 sequence (in the case of positive samples)
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 13 Sep 2021.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection Viral, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
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 1 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 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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.
What does the primary outcome measure?
RTqPCR result (time frame: 1 month). The study lists 2 primary outcomes in all. 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 13 Sep 2021.