Adaptive RCT of Corticosteroids for Severe Chlamydia Psittaci Pneumonia in Adults

NCT07352865 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: 2025-I2M-C&T-B-090D
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Psittacosis

Keywords

Psittacosis; community-acquired pneumonia; adaptive randomised controled trial; corticosteroids

Outcome Measures

Primary Outcomes (1)

• 28-day all cause mortality

  28 days from inclusion

Study Arms (3)

Standard of Care

PLACEBO COMPARATOR

Control group

Drug: Saline (0.9%, sterile, for infusion)

Low dose steroids

EXPERIMENTAL

treated with low dose corticosteroids

Drug: low dose Methylprednisolone

Moderate dose steroids

EXPERIMENTAL

treated with moderate dose corticosteroids

Drug: Moderate dose Methylprednisolone

Interventions

low dose Methylprednisolone DRUG

Methylprednisolone 0.5mg/kg ivgtt qd

Low dose steroids

Moderate dose Methylprednisolone DRUG

Methylprednisolone 1.0mg/kg ivgtt qd

Moderate dose steroids

Saline (0.9%, sterile, for infusion) DRUG

Sailine as control

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Admission to the Intensive Care Unit (ICU).
• Meeting the diagnostic criteria for community-acquired pneumonia (CAP).
• Meeting at least one of the major diagnostic criteria for severe pneumonia:
• (i) Requirement for endotracheal intubation and mechanical ventilation;
• (ii) Septic shock requiring vasopressor therapy after adequate fluid resuscitation.
• Or simultaneously fulfilling three of the minor criteria:
• (i) Respiratory rate ≥ 30 breaths/min;
• (ii) PaO₂/FiO₂ ≤ 250 mmHg;
• (iii) Multilobar infiltrates;
• (iv) Altered mental status and/or disorientation;
• (v) Blood urea nitrogen ≥ 20 mg/dL (7.12 mmol/L);
• (vi) Leukopenia (white blood cell count \< 4 × 10⁹/L);
• (vii) Thrombocytopenia (platelet count \< 100 × 10⁹/L);
• (viii) Hypothermia (core temperature \< 36 °C);

You may not qualify if:

• 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.
• Presence of cystic fibrosis, obstructive pneumonia, active influenza, pulmonary tuberculosis, or fungal infection.
• Active viral hepatitis or active herpesvirus infection.
• Bone marrow suppression or HIV infection.
• Refusal of mechanical ventilation and endotracheal intubation.
• Uncontrolled hyperglycemia (diabetic ketoacidosis with blood ketones \>3 mmol/L, or hyperosmolar hyperglycemic state with blood glucose \>33.3 mmol/L and elevated osmolality).
• Known allergy to corticosteroids.
• Patients requiring anti-inflammatory corticosteroids or replacement hydrocortisone for any reason, or those already receiving prednisone \>15 mg/day (or equivalent dose of another corticosteroid).
• Pregnant or breastfeeding women.

Sponsors & Collaborators

• Qingyuan Zhan: lead

MeSH Terms

Conditions

Psittacosis; Community-Acquired Pneumonia

Interventions

Sodium Chloride; Methylprednisolone

Condition Hierarchy (Ancestors)

Chlamydophila Infections; Chlamydiaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Community-Acquired Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: January 20, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: January 20, 2026

Record last verified: 2026-01