Adaptive RCT of Corticosteroids for Severe Chlamydia Psittaci Pneumonia in Adults

January 13, 2026 updated by: Qingyuan Zhan

An Embedded Adaptive Randomized Controlled Trial of Corticosteroid Therapy for Severe Chlamydia Psittaci Community-Acquired Pneumonia in Adults

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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);

(ix) Hypotension (systolic blood pressure < 90 mmHg) requiring aggressive fluid resuscitation.

  • 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).
  • Severe community-acquired pneumonia (SCAP) patients admitted to the emergency department/ward/ICU due to respiratory failure within < 72 hours.
  • Signed informed consent.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Standard of Care
Control group
Drug: Saline (0.9%, sterile, for infusion)
Sailine as control
Experimental: Low dose steroids
treated with low dose corticosteroids
Drug: low dose Methylprednisolone
Methylprednisolone 0.5mg/kg ivgtt qd
Experimental: Moderate dose steroids
treated with moderate dose corticosteroids
Drug: Moderate dose Methylprednisolone
Methylprednisolone 1.0mg/kg ivgtt qd

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
28-day all cause mortality
Time Frame: 28 days from inclusion
28 days from inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qingyuan Zhan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 15, 2026

Primary Completion (Estimated)

November 30, 2028

Study Completion (Estimated)

November 30, 2028

Study Registration Dates

First Submitted

January 13, 2026

First Submitted That Met QC Criteria

January 13, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-I2M-C&T-B-090D

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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