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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 adults. It predominantly affects young individuals, progresses rapidly, and is associated with a high incidence of respiratory failure and multiple organ dysfunction. At present, there is no effective antiviral therapy available in China, and the reported mortality rate ranges from 41.5% to 80%. How to effectively reduce the mortality of severe adenovirus pneumonia, on the basis of conventional supportive care, is crucial for improving the prognosis of critically ill patients and alleviating the burden on families and society. We are currently conducting an adaptive, randomized, open-label controlled trial aimed at reducing mortality in severe adenovirus pneumonia. The primary objective of this study is to evaluate the efficacy and safety of adjunctive corticosteroid therapy at different dosages, in addition to early standard supportive treatment, in lowering mortality among patients with severe adenovirus pneumonia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Placebo Comparator | Control group |
|
| Low dose steroids | Experimental | treated with low dose corticosteroids |
|
| Moderate dose steroids | Experimental | treated with moderate dose corticosteroids |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saline (0.9%, sterile, for infusion) | Drug | Sailine as control |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 28-day all cause mortality | 28 days from inclusion |
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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.
Exclusion Criteria:
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| ID | Term |
|---|---|
| D000258 | Adenovirus Infections, Human |
| D000257 | Adenoviridae Infections |
| D000098968 | Community-Acquired Pneumonia |
| ID | Term |
|---|---|
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D017714 | Community-Acquired Infections |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| low dose Methylprednisolone |
| Drug |
Methylprednisolone 0.5mg/kg ivgtt qd |
|
| Moderate dose Methylprednisolone | Drug | Methylprednisolone 1.0mg/kg ivgtt qd |
|
| D011014 |
| Pneumonia |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| D017670 |
| Sodium Compounds |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |