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A multicenter prospective cohort study to elucidate the clinical characteristics of non-HIV Pneumocystis pneumonia [RE-VISION-PCP 2 prospective study]

RE-VISION-PCP 2 prospective study

Nakakashima Kei

Kameda Medical Center

929 Higashi-cho, Kamogawa, Chiba 296-8602, Japan

kei.7.nakashima@gmail.com

Nakashima Kei

Kameda Medical Center

929 Higashi-cho, Kamogawa, Chiba 296-8602, Japan

+81-4-7092-2211

kei.7.nakashima@gmail.com

Recruiting

July. 01, 2026

Observational

non-randomized controlled trial

open(masking not used)

dose comparison control

parallel assignment

treatment purpose

1. Patients clinically diagnosed with non-HIV Pneumocystis pneumonia (non-HIV PCP) by a physician

Definition of PCP diagnosis
In principle, the diagnosis should meet all of the following criteria.

Host factor
HIV infection or a non-HIV condition associated with possible immunodeficiency.

Clinical criteria
Clinical symptoms consistent with PCP (dyspnea, cough, fever, or hypoxemia),
and
Chest radiograph or chest CT findings compatible with PCP (including bilateral or diffuse ground-glass opacities).

Microbiological criteria
Detection of Pneumocystis species in respiratory specimens (e.g., sputum or bronchoalveolar lavage fluid) by conventional staining methods (Grocott stain or Diff-Quick stain) or nucleic acid testing (LAMP or PCR),
or
An elevated serum beta-D-glucan level.

If the results of microbiological testing are not yet available because they require additional time, Criterion 3 does not necessarily need to be fulfilled. Cases are acceptable if the physician makes an overall clinical diagnosis of non-HIV PCP.

In principle, serum beta-D-glucan levels should be measured using either the Beta-Glucan Single M30 Test Wako (FUJIFILM Wako Pure Chemical Corporation) or the FUNGITEC G Test MKII (Nissui Pharmaceutical Co., Ltd.). An elevated serum beta-D-glucan level is defined as greater than 5 pg/mL when measured using the Beta-Glucan Single M30 Test Wako or greater than 20 pg/mL when measured using the FUNGITEC G Test MKII. However, if a new beta-D-glucan assay becomes available or measurement is performed using another validated method, this definition does not apply.

2.Patients who are 18 years of age or older at the time informed consent is obtained.

3.Patients who have provided written informed consent to participate in this study.

1. Patients who, in the judgment of the principal investigator (or sub-investigator), are unable or unwilling to cooperate with data collection or follow-up for this study.

2. Patients who, in the judgment of the principal investigator (or sub-investigator), are considered inappropriate for participation in this study for any other reason.

Both

non-HIV Pneumocystis pneumonia

All-cause mortality within 365 days

+81-3-5803-4547

Nov. 19, 2025

No

none