Corticosteroids for PJP in Non-HIV Immunocompromised Adults

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorQingyuan Zhan

About this trial

Pneumocystis jirovecii pneumonia (PJP) is one of the common severe complications in immunocompromised patients, with a reported mortality rate of 60-80%. Reducing mortality from PJP is crucial for improving outcomes in critically ill non-HIV immunocompromised patients and alleviating the burden on families and society. To address this medical challenge, our institution is conducting a study aimed at lowering PJP-related mortality. Specifically, we are performing an adaptive, randomized, open-label controlled trial in patients with severe PJP. The primary objective of this study is to scientifically evaluate the efficacy and safety of adjunctive corticosteroids at different dosages, in addition to early standard supportive care, for reducing mortality in severe PJP

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Age < 18 years.

Pregnant or breastfeeding women.

HIV infection.

No targeted PJP therapy administered or therapy not according to standard protocol.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Saline (0.9%, sterile, for infusion)

    Drug

    Saline for control

  • Low Dose Corticosteroids

    Drug

    Methylprednisolone 0.5mg/kg ivgtt qd

  • Moderate dose corticosteroids

    Drug

    Methylprednisolone 1.0mg/kg ivgtt qd

Treatment groups

240 Participants
are divided into 3 treatment groups
Group A: Standard of CarePlacebo comparator 1 intervention
Group B: Low dose steroidsExperimental treatment 1 intervention
Group C: Moderate dose steroidsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

28-days all cause mortality

28-days all cause mortality

Time frame
28 days from inclusion

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Qingyuan Zhan

Lead sponsor

China-Japan Friendship Hospital

Sponsor institution

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