Immunodeficiency and Suspected InfectionPATHOQUEST1NCT02007642
Evaluation of High Throughput Sequencing for Screening of Pathogens in Immunocompromised Patients With Suspected Infectious Disease.
An observational study of Immunodeficiency and Suspected Infection, run by Pathoquest at 2 sites in France.
Trial summary
The study patients are patients suffering from primary or secondary immunodeficiencies investigated in the Hospital Necker for a suspected infectious disease. The study purpose is to assess the performance of a High Throughput Sequencing method, the PATHOQUEST method (from sample preparation to bio informatic… Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Immunodeficiency and Suspected Infection
- What is being tested?
- Blood sampling / Body fluid sampling
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 2 sitesFrance
- Study dates
- Oct 2013to Oct 2014
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Immunocompromised patients hospitalized for a suspected infectious disease
Summary of inclusion criteria:
- Primary or secondary immunodeficiencies defined by
- Solid organ transplantation and immunosuppressive drug
- Recent chemotherapy
- Hematopoïetic Stem Cells transplantation
- Primary immune deficiency
- Auto-immune disease
- HIV infection
- Infection suspicion
- Microbiological investigation
- Adult or child above 1 year
- Hospitalization at Necker-Enfants malades hospital
- Registration to Healthcare organism
- ICF signature
Summary of exclusion criteria:
- Obvious diagnosis following clinical examination
- Participation in a clinical trial for a new drug
- People under legal guardianship
- People unable to fulfil the required medical follow-up
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Européen Georges Pompidou
Paris, 75015
Hopital Necker - Enfants malades
Paris, Île-de-France Region, 75015
About this study
Official title: Performance Assessment of High Throughput Sequencing for the Detection of Pathogens in Immunocompromised Patients With Suspected Infectious Disease.
The study patients are patients suffering from primary or secondary immunodeficiencies investigated in the Hospital Necker for a suspected infectious disease.
The study purpose is to assess the performance of a High Throughput Sequencing method, the PATHOQUEST method (from sample preparation to bio informatic analysis), versus the classic diagnostic approach.
The study will evaluate the capacity of the PATHOQUEST method to detect pathogens responsible for an infectious disease episode and will also evaluate the delay of obtention of results compared to the classic diagnostic approach.
- Conditions
- Immunodeficiency and Suspected Infection
- Being tested
- Blood sampling / Body fluid sampling
- Medical subject headings
- Immunologic Deficiency Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling / Body fluid samplingProcedure or surgery
During the hospitalization of the patient, when a sampling is done for classic follow-up and diagnosis, additionnal blood sampling will be done, for the PATHOQUEST method.
Other body fluids might be taken (if the sampling is done for the classic follow-up), such as cerebrospinal fluid, ascite...
| Study group | Role | What they receive |
|---|---|---|
| No study treatment | Not described Receives: Procedure: Blood sampling / Body fluid sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of pathogens responsible for the infection
The primary outcome will assess the number of diagnostics obtained by the PATHOQUEST method and classic diagnostic approach.
Measured: 1 year
Secondary outcomes (2)
Delay of obtention of diagnostic
The delay of obtention of results will be compared to determine which approach allows an earlier diagnosis.
Measured: 1 year
Economic impact of the PATHOQUEST method
Comparison of the cost of the classic diagnostic approach and PATHOQUEST method, including cost of the hospital stay, microbiological tests performed, empirical anti-infectious drugs prescribed.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunodeficiency and Suspected 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pathoquest
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Imagine Institute
- Responsible party
- Sponsor
- Investigators
- Marc Lecuit, Pr, Principal investigator, marc.lecuit@nck.aphp.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02007642
- Sponsor's protocol ID
- PTQCT01-2013
- Acronym
- PATHOQUEST1
- Status last verified
- Oct 2013
- First submitted
- 29 Nov 2013
- Last updated
- 21 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Assessment of High Throughput Sequencing for the Detection of Pathogens in Immunocompromised Patients With Suspected Infectious Disease.
- ClinicalTrials.gov ID
- NCT02007642
- Acronym / sponsor ID
- PATHOQUEST1 / PTQCT01-2013
- Conditions
- Immunodeficiency and Suspected Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- PathoquestIndustry (pharma, biotech, devices)
- Collaborators
- Imagine Institute
- Study start
- Oct 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 11 Dec 2013 (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.
The study patients are patients suffering from primary or secondary immunodeficiencies investigated in the Hospital Necker for a suspected infectious disease.
The study purpose is to assess the performance of a High Throughput Sequencing method, the PATHOQUEST method (from sample preparation to bio informatic analysis), versus the classic diagnostic approach.
The study will evaluate the capacity of the PATHOQUEST method to detect pathogens responsible for an infectious disease episode and will also evaluate the delay of obtention of results compared to the classic diagnostic approach.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No study treatment | – | Procedure: Blood sampling / Body fluid sampling |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Immunocompromised patients hospitalized for a suspected infectious disease
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 |
|---|---|---|
| Blood sampling / Body fluid samplingDuring the hospitalization of the patient, when a sampling is done for classic follow-up and diagnosis, additionnal blood sampling will be done, for the PATHOQUEST method. Other body fluids might be taken (if the sampling is done for the classic follow-up), such as cerebrospinal fluid, ascite... | Procedure or surgery | No study treatment |
Primary outcome
Identification of pathogens responsible for the infection
Time frame: 1 year
The primary outcome will assess the number of diagnostics obtained by the PATHOQUEST method and classic diagnostic approach.
2 secondary outcomes
Delay of obtention of diagnostic
Time frame: 1 year
Economic impact of the PATHOQUEST method
Time frame: 1 year
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 21 Apr 2015.
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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.
Marc Lecuit, Pr principal investigator
marc.lecuit@nck.aphp.fr
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 Immunodeficiency and Suspected Infection, run by Pathoquest 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?
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 21 Apr 2015. 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?
Identification of pathogens responsible for the infection (time frame: 1 year). 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 21 Apr 2015.