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NCT Number: NCT06890078

Optimizing the Diagnosis of Pneumocystis in Immunocompromised Patients

Evaluate new diagnostic methods using qPCR on non-invasive samples, compared with reference techniques for the positive diagnosis of pneumocystis (PcP) in immunocompromised patients

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Key information

Conditions

Pneumocystis Bacterial Infections and Mycoses Immunocompromised Patients Infections Lung Diseases Lung Diseases, Fungal Mycoses Pneumocystis Infections Pneumonia Pneumonia, Pneumocystis Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Lariboisière AP-HP Maladies infectieuses, Paris, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult patients with suspected pneumocystis
  • with an indication for bronchial fibroscopy for BAL or induced sputum
  • no opposition to the research from the adult patient or his or her next of kin research for patients unable to express their non-opposition

Exclusion criteria

  • Pneumocystis treated for more than 72 hours
  • pregnancy/breast-feeding
  • adult patients deprived of liberty, protected

Treatment and study plan

Biological sampling

Other

Mouthwash, nasopharyngeal swab, blood sampling

Primary outcomes

  1. Pearson correlation coefficient

    Time frame: At inclusion

    Pearson correlation coefficient between the fungal load obtained by PCR on nasopharyngeal swabs nasopharyngeal swab and buccal lavage and that obtained by reference samples (induced sputum or BAL) in patients with confirmed PcP.

Secondary outcomes

  1. Fungal load by qPCR

    Time frame: At inclusion

    Quantitative fungal load results obtained by qPCR on nasopharyngeal swab, mouthwash, induced sputum, BAL

  2. Fungal load by serum PCR

    Time frame: At inclusion

    Quantitative fungal load results obtained by serum PCR

  3. Beta D glucan blood levels

    Time frame: At inclusion

Study contacts

Contact information is provided by the study sponsor or research team.

Agathe Vigouroux, MD

CONTACT

[email protected]

0142494683 ext. +33

Jérôme Lambert, MD PhD

CONTACT

[email protected]

+33 1 42 49 97 42 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Optimisation du Diagnostic de Pneumocystose Chez Les Patients Immunodéprimés

Acronym: OPTIJIROVEC

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 21, 2025
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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