Pneumocystis Pneumonia Diagnosis in HIV- Patients

Pneumonia, Pneumocystis Clinical Trial

— PNEUMOQUANT  

Official title:

Pneumocystis Pneumonia Diagnosis in HIV- Patients: Assessment of the Real Time Polymerase Chain Reaction Quantification on Oropharyngeal Rinse

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02648256
• Other study ID #: 2015-A00408-41
• Secondary ID: 35RC14_9890
• Status: Recruiting
• Phase: N/A
• Start date: January 2016
• Est. completion date: August 2024

Study information

• Verified date: April 2022
• Source: Rennes University Hospital
• Contact: Florence Robert-Gangneux, Md, PhD
• Email: florence.robertgangneux[@]chu-rennes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1250
• Est. completion date: August 2024
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Pneumocystis

Intervention

Other:
• Polymerase Chain Reaction on Oropharyngeal rinse

Locations

Country	Name	City	State
France	CHU Amiens	Amiens
France	CHU Brest	Brest
France	CHU Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At the end of inclusion period (24 months)
Secondary	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	At the end of inclusion period (24 months)
Secondary	Evaluation of serum dosage of ß-1,3-D glucan	Definition of a positivity threshold to evoke a certain Pneumocystis jirovecii pneumonia, alone or in combination with Polymerase Chain Reaction.	At the end of inclusion period (24 months)
Secondary	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)	At the end of inclusion period (24 months)