Status:
NOT_YET_RECRUITING
Adaptive RCT of Corticosteroids for Severe Adenovirus Pneumonia in Adults
Lead Sponsor:
Qingyuan Zhan
Conditions:
Adenovirus Infections, Human
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Severe community-acquired pneumonia caused by adenovirus (hereafter referred to as severe adenovirus pneumonia) is one of the common forms of severe community-acquired pneumonia in immunocompetent adu...
Eligibility Criteria
Inclusion
- 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 adenovirus etiology: at least one positive nucleic acid test (PCR) or next-generation sequencing (NGS) result for adenovirus and/or Pneumocystis jirovecii 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
- 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.
Key Trial Info
Start Date :
September 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
262 Patients enrolled
Trial Details
Trial ID
NCT07152600
Start Date
September 8 2025
End Date
December 31 2027
Last Update
September 3 2025
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