Pneumocystis Pneumonia Diagnosis in HIV- Patients (PNEUMOQUANT)
Primary Purpose
Pneumonia, Pneumocystis
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Polymerase Chain Reaction on Oropharyngeal rinse
Sponsored by
About this trial
This is an interventional diagnostic trial for Pneumonia, Pneumocystis focused on measuring Pneumocystis jirovecii, Polymerase Chain Reaction, Oropharyngeal Rinse
Eligibility Criteria
Inclusion Criteria:
- Age over 18 years
- Clinical or radiological indication for a broncho-alveolar lavage to search infectious agents including Pneumocystis jirovecii
- Patients with risk factors for developing a Pneumocystis jirovecii pneumonia : underlying malignancy (solid cancer, hematologic disease), organ transplant or hematopoietic stem cells, autoimmune disease or chronic inflammatory disease justifying immunosuppressive therapy (chemotherapy anticancer, immunomodulatory, biotherapy, corticosteroids) or patient treated with corticosteroids for more than a month or congenital immune deficiency or other causes of immunosuppression (excluding human immunodeficiency virus) at the discretion of the clinician,
- Informed consent given.
Exclusion Criteria:
- Patient human immunodeficiency virus positive
- Contraindication to the achievement of broncho-alveolar lavage,
- Contraindication to the achievement of a Oropharyngeal rinse (disorder of consciousness, swallowing disorder),
- Prophylaxis with cotrimoxazole or aerosol pentamidine,
- Empirical curative treatment with cotrimoxazole or other curative therapeutic alternative (pentamidine, atovaquone, dapsone, clindamycin-primaquine) started for more than 48 hours,
- Major person under legal protection (backup justice, trusteeship, guardianship), person deprived of liberty.
Sites / Locations
- CHU AmiensRecruiting
- CHU BrestRecruiting
- CHU RennesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Oropharyngeal rinse
Arm Description
Polymerase Chain Reaction on Oropharyngeal rinse: Dosage of Pneumocystis jiroveci will be performed on the broncho-alveolar lavage following the usual routine diagnosis. Polymerase Chain Reaction will be performed on the broncho-alveolar lavage and the oropharyngeal rinse (not communicated to the clinician result) in the same series, in order to compare the results of the fungal quantification.
Outcomes
Primary Outcome Measures
Positive Predictive Value of Polymerase Chain Reaction on oropharyngeal rinse
Definition of a numerical threshold from a multivariate analysis, for positioning the result of this test in combination with other clinical or laboratory parameters.
Secondary Outcome Measures
Broncho-alveolar lavage Standardization
Definition of a quantitative threshold (number of copies / mL) for the interpretation of the Polymerase Chain Reaction on the broncho-alveolar lavage to estimate at best positive predictive value of Pneumocystis Polymerase Chain Reaction
Evaluation of serum dosage of β-1,3-D glucan
Definition of a positivity threshold to evoke a certain Pneumocystis jirovecii pneumonia, alone or in combination with Polymerase Chain Reaction.
Prevalence of genetic mutations of pneumocystis jirovecii
Analysis of the prevalence of mutations in the gene encoding the synthase dihydropteroate Pneumocystis jirovecii in patients with Pneumocystis jirovecii pneumonia or colonized and comparison with previous calculations Brittany and Picardy régions using a parametric test (t test) or nonparametric (Mann-test Whitney)
Full Information
NCT ID
NCT02648256
First Posted
January 5, 2016
Last Updated
April 29, 2022
Sponsor
Rennes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02648256
Brief Title
Pneumocystis Pneumonia Diagnosis in HIV- Patients
Acronym
PNEUMOQUANT
Official Title
Pneumocystis Pneumonia Diagnosis in HIV- Patients: Assessment of the Real Time Polymerase Chain Reaction Quantification on Oropharyngeal Rinse
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 2016 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Pneumocystis jirovecii pneumonia is a serious and frequent infection in immunocompromised patients, whose evolution is potentially fatal if untreated. It is the most common opportunistic infections classifying patients infected with human immunodeficiency virus (human immunodeficiency virus +) at the stage acquired immune deficiency syndrome. Data from the french Institute for Health Watch showed in 2011 that 31% of 1400 cases of acquired immune deficiency syndrome were revealed by Pneumocystis jirovecii pneumonia.
Pneumocystis jirovecii pneumonia also increasingly concerns immunocompromised human immunodeficiency virus negative patients, due to the increasing use of immunosuppressive therapies (including corticosteroids), of anticancer cytostatics and biotherapies, in the context of grafts, transplants, but also from autoimmune or inflammatory chronic diseases.
Recent data show that the number of cases occurring in patients Pneumocystis jirovecii pneumonia human immunodeficiency virus - in France is now higher than the cases occurring in Pneumocystis jirovecii pneumonia +. The severity of the Pneumocystis jirovecii pneumonia is increased in patients with human immunodeficiency virus -, in whom the evolution is faster, with mechanical ventilation often required and higher mortality, requiring a fast and early diagnosis. Routine diagnosis relies on the detection of the fungus in the bronchoalveolar lavage, using stains (May Grunwald Giemsa or immunofluorescence) and Polymerase Chain Reaction. Polymerase Chain Reaction provides a diagnostic gain in immunocompromised patients not infected with human immunodeficiency virus that may present a pejorative table quickly despite low fungal burden. However, the deoxyribonucleic acid of the fungus can sometimes be detected in the absence of scalable Pneumocystis jirovecii pneumonia, and then shows a pulmonary colonization by Pneumocystis jirovecii. It is therefore important to improve the positive predictive value of Pneumocystis Polymerase Chain Reaction, to guide the management of optimal patient.
In this work, the investigators propose to evaluate the Polymerase Chain Reaction on oropharyngeal rinse, non-invasive sampling and therefore probably less often positive and specific active infection. The investigators will develop a quantitative Polymerase Chain Reaction to identify a fungal load threshold number of copies / mL for diagnosing Pneumocystis jirovecii pneumonia with better positive predictive value.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Pneumocystis
Keywords
Pneumocystis jirovecii, Polymerase Chain Reaction, Oropharyngeal Rinse
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Oropharyngeal rinse
Arm Type
Experimental
Arm Description
Polymerase Chain Reaction on Oropharyngeal rinse:
Dosage of Pneumocystis jiroveci will be performed on the broncho-alveolar lavage following the usual routine diagnosis.
Polymerase Chain Reaction will be performed on the broncho-alveolar lavage and the oropharyngeal rinse (not communicated to the clinician result) in the same series, in order to compare the results of the fungal quantification.
Intervention Type
Other
Intervention Name(s)
Polymerase Chain Reaction on Oropharyngeal rinse
Primary Outcome Measure Information:
Title
Positive Predictive Value of Polymerase Chain Reaction on oropharyngeal rinse
Description
Definition of a numerical threshold from a multivariate analysis, for positioning the result of this test in combination with other clinical or laboratory parameters.
Time Frame
At the end of inclusion period (24 months)
Secondary Outcome Measure Information:
Title
Broncho-alveolar lavage Standardization
Description
Definition of a quantitative threshold (number of copies / mL) for the interpretation of the Polymerase Chain Reaction on the broncho-alveolar lavage to estimate at best positive predictive value of Pneumocystis Polymerase Chain Reaction
Time Frame
At the end of inclusion period (24 months)
Title
Evaluation of serum dosage of β-1,3-D glucan
Description
Definition of a positivity threshold to evoke a certain Pneumocystis jirovecii pneumonia, alone or in combination with Polymerase Chain Reaction.
Time Frame
At the end of inclusion period (24 months)
Title
Prevalence of genetic mutations of pneumocystis jirovecii
Description
Analysis of the prevalence of mutations in the gene encoding the synthase dihydropteroate Pneumocystis jirovecii in patients with Pneumocystis jirovecii pneumonia or colonized and comparison with previous calculations Brittany and Picardy régions using a parametric test (t test) or nonparametric (Mann-test Whitney)
Time Frame
At the end of inclusion period (24 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age over 18 years
Clinical or radiological indication for a broncho-alveolar lavage to search infectious agents including Pneumocystis jirovecii
Patients with risk factors for developing a Pneumocystis jirovecii pneumonia : underlying malignancy (solid cancer, hematologic disease), organ transplant or hematopoietic stem cells, autoimmune disease or chronic inflammatory disease justifying immunosuppressive therapy (chemotherapy anticancer, immunomodulatory, biotherapy, corticosteroids) or patient treated with corticosteroids for more than a month or congenital immune deficiency or other causes of immunosuppression (excluding human immunodeficiency virus) at the discretion of the clinician,
Informed consent given.
Exclusion Criteria:
Patient human immunodeficiency virus positive
Contraindication to the achievement of broncho-alveolar lavage,
Contraindication to the achievement of a Oropharyngeal rinse (disorder of consciousness, swallowing disorder),
Prophylaxis with cotrimoxazole or aerosol pentamidine,
Empirical curative treatment with cotrimoxazole or other curative therapeutic alternative (pentamidine, atovaquone, dapsone, clindamycin-primaquine) started for more than 48 hours,
Major person under legal protection (backup justice, trusteeship, guardianship), person deprived of liberty.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Florence Robert-Gangneux, Md, PhD
Email
florence.robertgangneux@chu-rennes.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Ganivet
Email
anne.ganivet@chu-rennes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florence Robert-Gangneux, Md, PhD
Organizational Affiliation
CHU Rennes
Official's Role
Study Director
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Totet, MD, PhD
First Name & Middle Initial & Last Name & Degree
Vincent Jounieaux, MD, PhD
First Name & Middle Initial & Last Name & Degree
Jean-Luc Schmit, MD, PhD
Facility Name
CHU Brest
City
Brest
ZIP/Postal Code
29200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gilles Nevez, MD-PhD
First Name & Middle Initial & Last Name & Degree
Francis Couturaud, MD-PhD
First Name & Middle Initial & Last Name & Degree
Séverine Ansart, MD-PhD
Facility Name
CHU Rennes
City
Rennes
ZIP/Postal Code
35000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Pierre Gangneux, MD, PhD
First Name & Middle Initial & Last Name & Degree
Yves Le Tulzo, MD, PhD
First Name & Middle Initial & Last Name & Degree
Stéphane Jouneau, MD, PhD
First Name & Middle Initial & Last Name & Degree
Pierre Tattevin, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
Pneumocystis Pneumonia Diagnosis in HIV- Patients
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