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NCT02648256Completed

Pneumocystis Pneumonia Diagnosis in HIV- Patients

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

Source: ClinicalTrials.gov · Last updated 15 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
408 (actual)
First submitted
5 Jan 2016
Start date
1 Jan 2016
Primary completion date
31 Jul 2023
Lead sponsor
Rennes University Hospital
NCT number
NCT02648256

What you commit to

  • Study type: Interventional
  • Participants enrolled: 408
  • From 1 Jan 2016 to the primary completion date, 31 Jul 2023
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Empirical curative treatment with cotrimoxazole or other curative therapeutic alternative (pentamidine, atovaquone, dapsone, clindamycin-primaquine) started for more than 48 hours,

Other illness

  • Contraindication to the achievement of a Oropharyngeal rinse (disorder of consciousness, swallowing disorder),

Other

  • Patient human immunodeficiency virus positive
  • Contraindication to the achievement of broncho-alveolar lavage,
  • Prophylaxis with cotrimoxazole or aerosol pentamidine,
  • Major person under legal protection (backup justice, trusteeship, guardianship), person deprived of liberty.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU Amiens
Coordinator of this site? Confirm its status
AmiensFranceUnknown status
Chu Brest
Coordinator of this site? Confirm its status
BrestFranceUnknown status
CHU Rennes
Coordinator of this site? Confirm its status
RennesFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.