Adaptive RCT of Corticosteroids for Severe Chlamydia Psittaci Pneumonia in Adults

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

About this trial

Severe community-acquired pneumonia caused by psittacosis is a form of atypical-pathogen community-acquired pneumonia that often requires critical care management. It can occur in immunocompetent adults, has an abrupt onset and rapid progression, and may quickly deteriorate to profound hypoxemia, acute respiratory distress syndrome, and multiple organ dysfunction, frequently necessitating ICU admission. In a multicenter cohort from 19 tertiary hospitals in China with metagenomic next-generation sequencing (mNGS)-confirmed severe CAP complicated by acute hypoxemic respiratory failure, approximately 44% of patients required invasive mechanical ventilation and ICU mortality was 8.9%, indicating a substantial risk of death and severe morbidity among critically ill patients. The World Health Organization (WHO) reported an increase in cases across several European countries from 2023 to early 2024, with five deaths, suggesting that the disease burden and public health significance of psittacosis may have been underestimated for a prolonged period.

At present, the cornerstone of psittacosis pneumonia management is early recognition and timely pathogen-directed antibiotic therapy (tetracyclines, particularly doxycycline, as first-line treatment), together with well-established organ-support strategies. Optimizing comprehensive management beyond early standard supportive care and guideline-concordant antimicrobial therapy (including targeted antibiotics and organ support) to further reduce mortality in severe psittacosis pneumonia is therefore of major clinical importance for improving outcomes in critically ill patients and alleviating the burden on families and society. Accordingly, we plan to conduct an adaptive, randomized, open-label, controlled trial to evaluate the efficacy and safety of adjunctive corticosteroid regimens at different doses, in addition to early standard supportive care, for reducing mortality in patients with severe psittacosis pneumonia.

Eligibility criteria

Qualifiers

Age ≥ 18 years.

Admission to the Intensive Care Unit (ICU).

Meeting the diagnostic criteria for community-acquired pneumonia (CAP).

Confirmed Chlamydia psittaci etiology (psittacosis): at least one positive nucleic acid test (PCR/RT-PCR) or next-generation sequencing (NGS) result for Chlamydia psittaci in respiratory specimens (respiratory secretions, throat swabs, or bronchoalveolar lavage fluid).

Disqualifiers

Patients receiving vasopressor therapy for septic shock at the time of enrollment.

Terminally ill patients (expected survival <30 days, e.g., advanced malignancy).

Clinical history suggesting overt aspiration.

Documented active gastrointestinal bleeding.

Trial design

Treatments tested in this trial

  • Saline (0.9%, sterile, for infusion)
  • low dose Methylprednisolone
  • Moderate dose Methylprednisolone

Treatment groups

100 Participants
are divided into 3 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Qingyuan Zhan

Lead sponsor

China-Japan Friendship Hospital

Sponsor institution