Interest of Real-time Polymerase Chain Reaction (PCR) in the Diagnosis of Fungal Infections

NCT00876096 | Completed

• 1 other identifier: 06-API-03
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 4

Brief 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 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.

Conditions

Healthy; Fungal Infections

Keywords

Diagnosis, Differential

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  1 year

Study Arms (1)

1

OTHER

precocious diagnosis and taken care therapeutics of the systematic athlete's feet

Other: Catch of blood then PCR

Interventions

Catch of blood then PCR OTHER

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.

1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy subjects: Chosen healthy subjects are donors of the Blood transfusion centre of NICE
• Ill subjects:
• 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

You may not qualify if:

• Minor or person over 18 under tutelage.
• Subjects deprived of freedom.
• Patients cancelling their consent.
• Patients violating the research protocol.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (4)

CAL

Nice, Alpes-maritimes, 06001, France

Location

CHU de Nice - 4 avenue Reine Victoria

Nice, Alpes-Maritimes, 06001, France

Location

CHU de Rennes

Rennes, France

Location

CHU de Touloluse - hôpital de Rangueil

Toulouse, 31 059, France

Location

MeSH Terms

Conditions

Mycoses; Disease

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• MARTY Pierre, PhD

  CHU de Nice - laboratoire de parasitologie- Hôpital de l'Archet - 151 Route de saint-antoine de ginestière 06200 Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2009
• First Posted: April 6, 2009
• Study Start: February 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: March 1, 2012
• Last Updated: April 12, 2024

Record last verified: 2009-04

Locations

FR (4)