Saline (0.9%, sterile, for infusion)
DrugSailine as control
NCT Number: NCT07352865
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 3
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(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.
Exclusion criteria
Sailine as control
Methylprednisolone 0.5mg/kg ivgtt qd
Methylprednisolone 1.0mg/kg ivgtt qd
Time frame: 28 days from inclusion
Qingyuan Zhan
Other
An Embedded Adaptive Randomized Controlled Trial of Corticosteroid Therapy for Severe Chlamydia Psittaci Community-Acquired Pneumonia in Adults
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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