HealthyNCT00876096
Interest of Real-time Polymerase Chain Reaction (PCR) in the Diagnosis of Fungal Infections
A study testing Catch of blood then PCR in people with Healthy and Fungal Infections, run by Centre Hospitalier Universitaire de Nice at 4 sites in France.
Trial summary
Invasive fungal infections have a major impact on the morbidity and mortality of immunocompromised patients, including patients with hematological malignancies, neutropenic patients, human immunodeficiency virus infected patients, diabetics, solid organ transplanted patients and patients admitted in an intensive care… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Fungal Infections
- What is being tested?
- Catch of blood then PCR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 4 sitesFrance
- Study dates
- Feb 2007to Mar 2012
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects: Chosen healthy subjects are donors of the Blood transfusion centre of NICE
- Ill subjects:
- Medical examination compatible with inclusion to donate blood
- To sign lit consent
- Affiliation to the regime of French national health and pensions organization
- Patient as whom there is intention to deal by systematic antifongique, Criteria, linked to the guest, clinical and microbiological are defined
Who cannot join
- Minor or person over 18 under tutelage.
- Subjects deprived of freedom.
- Patients cancelling their consent.
- Patients violating the research protocol.
Trial locations and contacts
4 sites in 1 country.
France4 sites
CAL
Nice, Alpes-maritimes, 06001
CHU de Nice - 4 avenue Reine Victoria
Nice, Alpes-Maritimes, 06001
CHU de Rennes
Rennes
CHU de Touloluse - hôpital de Rangueil
Toulouse, 31 059
About this study
Official title: Development and Validation of Fungal Extraction and Real -Time PCR Assay for the Diagnosis of Medically Important Fungal Infections in Blood Samples.
Invasive fungal infections have a major impact on the morbidity and mortality of immunocompromised patients, including patients with hematological malignancies, neutropenic patients, human immunodeficiency virus infected patients, diabetics, solid organ transplanted patients and patients admitted in an intensive care unit.
The survival of these patients depends on early diagnosis and prompt appropriate antifungal treatment. The early diagnosis of these infections is difficult because of the lack of sensitive test methods, notably blood cultures. For these reasons, the investigators decided to develop a real-time PCR (Polymerase Chain Reaction) assay on blood samples. It should allow rapid response to establish a positive or negative diagnosis of invasive fungal infection, could contribute strongly to the decision of treating using antifungals, and should monitor the effectiveness and the optimization of antifungal prescriptions.
Read more
The investigators' objectives are: First, to validate an extraction method from blood infected by fungi species. Secondly, the investigators want to develop three real-time PCR: A fungal real-time PCR able to detect most fungal species; a real-time PCR targetting Candida albicans and Aspergillus fumigatus which are two clinically important pathogens. Then blood samples of patients (classified according to EORTC consensus) will be collected during the study in order to evaluate and validate our method on clinical samples. Results will allow the investigators to determine the sensitivity, specificity and reproducibility, negative and predictive values.
Overall, the investigators' work aims to evaluate the clinical impact of real-time PCR in the early diagnosis of invasive fungal infections and on the initiation or stopping of antifungal therapy. The economic impact resulting from the use of this method will be evaluated.
Read the detailed description
Invasive fungal infections are a major cause of morbidity and mortality in immunocompromised patients. Among them, patients with hematological malignancies, neutropenic patients, human immunodeficiency virus infected patients, diabetics, solid organ transplanted patients and patients admitted in an intensive care unit are particularly at high risk.
The survival of these patients depends on early diagnosis and prompt appropriate antifungal treatment. The early diagnosis of these infections is difficult because of the lack of sensitive test methods, notably blood cultures. Its sensitivity is poor or close-zero for aspergillosis. In addition, the response time is several days. For these reasons, we decided to develop a real-time PCR (Polymerase Chain Reaction) assay on blood samples. It should allow rapid response to establish a positive or negative diagnosis of invasive fungal infection, it could contribute strongly to the decision of treating using antifungals, and it should monitor the effectiveness and the optimization of antifungal prescriptions.
Methods:
Our project is a multicentre prospective inter-regional collaborative work between Nice, Rennes and Toulouse Mycological and parasitological laboratories. Our objectives are: First, to validate an extraction method from blood infected by fungi species. The three laboratories will work together to determine the best extraction method, since there is no consensus method for the extraction of nucleic acids of fungal origin in the context of human infections. The numerous extraction techniques already used lead to differences in the PCR results. As a consequence, inter-laboratory comparisons are not easy. Secondly, we aim to develop three real-time PCR assays: A panfungal real-time PCR assay able to detect most fungal species responsible for human diseases; a real-time PCR assay targetting Candida albicans and one targeting Aspergillus fumigatus which are two clinically important pathogens. Then patient blood samples (classified according to EORTC consensus) will be collected during the study in order to evaluate and validate our method on clinical samples. Results will allow us to determine the sensitivity, specificity and reproducibility, negative and predictive values.
Objectives Overall, our work aims to evaluate the clinical impact of real-time PCR in the early diagnosis of invasive fungal infections and on the initiation or stopping of antifungal therapy. The economic impact resulting from the use of this method will be evaluated. Indeed, an excellent predictive negative value of a panfungal real-time PCR assay could warrant a decrease in the use of empirical antifungal therapy
- Conditions
- Healthy, Fungal Infections
- Being tested
- Catch of blood then PCR
- Keywords
- Diagnosis, Differential
- Medical subject headings
- Mycoses, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catch of blood then PCROther
To optimize the technology of extraction of nucleic acids of origin fongique by collaborating with the laboratories of Parasitologie and Mycology of the TEACHING HOSPITAL of Rennes and Toulouse.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | precocious diagnosis and taken care therapeutics of the systematic athlete's feet Receives: Other: Catch of blood then PCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
The evaluation will be conducted on blood samples inoculated with known concentrations of numerous fungal species (various Candida sp, various Aspergillus sp., Cryptococcus sp. etc…). Extraction method and PCR techniques
Measured: 1 year
Secondary outcomes (1)
IN Nice, Rennes and Toulouse Teaching hospitals, patients suspected of invasive fungal infection will be included in order to classified in three categories: proven, probable and possible fungal infection, according to EORTC consensus.
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 posted6 Apr 2009 (estimated)
- Study startFeb 2007
- Primary completionJul 2009
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MARTY Pierre, PhD, Principal investigator, CHU de Nice - laboratoire de parasitologie- Hôpital de l'Archet - 151 Route de saint-antoine de ginestière 06200 Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00876096
- Sponsor's protocol ID
- 06-API-03
- Status last verified
- Apr 2009
- First submitted
- 3 Apr 2009
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of Fungal Extraction and Real -Time PCR Assay for the Diagnosis of Medically Important Fungal Infections in Blood Samples.
- ClinicalTrials.gov ID
- NCT00876096
- Acronym / sponsor ID
- 06-API-03
- Conditions
- Healthy, Fungal Infections
- Keywords
- Diagnosis, Differential
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Feb 2007 (actual)
- Primary completion
- Jul 2009 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 6 Apr 2009 (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.
Invasive fungal infections have a major impact on the morbidity and mortality of immunocompromised patients, including patients with hematological malignancies, neutropenic patients, human immunodeficiency virus infected patients, diabetics, solid organ transplanted patients and patients admitted in an intensive care unit.
The survival of these patients depends on early diagnosis and prompt appropriate antifungal treatment. The early diagnosis of these infections is difficult because of the lack of sensitive test methods, notably blood cultures. For these reasons, the investigators decided to develop a real-time PCR (Polymerase Chain Reaction) assay on blood samples. It should allow rapid response to establish a positive or negative diagnosis of invasive fungal infection, could contribute strongly to the decision of treating using antifungals, and should monitor the effectiveness and the optimization of antifungal prescriptions.
The investigators' objectives are: First, to validate an extraction method from blood infected by fungi species. Secondly, the investigators want to develop three real-time PCR: A fungal real-time PCR able to detect most fungal species; a real-time PCR targetting Candida albicans and Aspergillus fumigatus which are two clinically important pathogens. Then blood samples of patients (classified according to EORTC consensus) will be collected during the study in order to evaluate and validate our method on clinical samples. Results will allow the investigators to determine the sensitivity, specificity and reproducibility, negative and predictive values.
Overall, the investigators' work aims to evaluate the clinical impact of real-time PCR in the early diagnosis of invasive fungal infections and on the initiation or stopping of antifungal therapy. The economic impact resulting from the use of this method will be evaluated.
Detailed description
Invasive fungal infections are a major cause of morbidity and mortality in immunocompromised patients. Among them, patients with hematological malignancies, neutropenic patients, human immunodeficiency virus infected patients, diabetics, solid organ transplanted patients and patients admitted in an intensive care unit are particularly at high risk.
The survival of these patients depends on early diagnosis and prompt appropriate antifungal treatment. The early diagnosis of these infections is difficult because of the lack of sensitive test methods, notably blood cultures. Its sensitivity is poor or close-zero for aspergillosis. In addition, the response time is several days. For these reasons, we decided to develop a real-time PCR (Polymerase Chain Reaction) assay on blood samples. It should allow rapid response to establish a positive or negative diagnosis of invasive fungal infection, it could contribute strongly to the decision of treating using antifungals, and it should monitor the effectiveness and the optimization of antifungal prescriptions.
Methods:
Our project is a multicentre prospective inter-regional collaborative work between Nice, Rennes and Toulouse Mycological and parasitological laboratories. Our objectives are: First, to validate an extraction method from blood infected by fungi species. The three laboratories will work together to determine the best extraction method, since there is no consensus method for the extraction of nucleic acids of fungal origin in the context of human infections. The numerous extraction techniques already used lead to differences in the PCR results. As a consequence, inter-laboratory comparisons are not easy. Secondly, we aim to develop three real-time PCR assays: A panfungal real-time PCR assay able to detect most fungal species responsible for human diseases; a real-time PCR assay targetting Candida albicans and one targeting Aspergillus fumigatus which are two clinically important pathogens. Then patient blood samples (classified according to EORTC consensus) will be collected during the study in order to evaluate and validate our method on clinical samples. Results will allow us to determine the sensitivity, specificity and reproducibility, negative and predictive values.
Objectives Overall, our work aims to evaluate the clinical impact of real-time PCR in the early diagnosis of invasive fungal infections and on the initiation or stopping of antifungal therapy. The economic impact resulting from the use of this method will be evaluated. Indeed, an excellent predictive negative value of a panfungal real-time PCR assay could warrant a decrease in the use of empirical antifungal therapy
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: Catch of blood then PCRprecocious diagnosis and taken care therapeutics of the systematic athlete's feet |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy subjects: Chosen healthy subjects are donors of the Blood transfusion centre of NICE
- Ill subjects:
Key exclusion criteria (4 listed)
- Minor or person over 18 under tutelage.
- Subjects deprived of freedom.
- Patients cancelling their consent.
- Patients violating the research protocol.
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 |
|---|---|---|
| Catch of blood then PCRTo optimize the technology of extraction of nucleic acids of origin fongique by collaborating with the laboratories of Parasitologie and Mycology of the TEACHING HOSPITAL of Rennes and Toulouse. | Other | 1 |
Primary outcome
The evaluation will be conducted on blood samples inoculated with known concentrations of numerous fungal species (various Candida sp, various Aspergillus sp., Cryptococcus sp. etc…). Extraction method and PCR techniques
Time frame: 1 year
1 secondary outcome
IN Nice, Rennes and Toulouse Teaching hospitals, patients suspected of invasive fungal infection will be included in order to classified in three categories: proven, probable and possible fungal infection, according to EORTC consensus.
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 12 Apr 2024.
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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.
MARTY Pierre, PhD principal investigator
CHU de Nice - laboratoire de parasitologie- Hôpital de l'Archet - 151 Route de saint-antoine de ginestière 06200 Nice
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catch of blood then PCR in people with Healthy and Fungal Infections, run by Centre Hospitalier Universitaire de Nice at 4 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 6 inclusion and 4 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 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
The evaluation will be conducted on blood samples inoculated with known concentrations of numerous fungal species (various Candida sp, various Aspergillus sp., Cryptococcus sp. etc…). Extraction method and PCR techniques (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 12 Apr 2024.