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Not yet recruiting NCT07152600

Adaptive RCT of Corticosteroids for Severe Adenovirus Pneumonia in Adults

Phase III Interventional Adenovirus Infections, Human

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Saline (0.9%, sterile, for infusion), low dose Methylprednisolone, Moderate dose Methylprednisolone.
Who it may be relevant to
Registry conditions: Adenovirus Infections, Human. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Saline (0.9%, sterile, for infusion)
    Sailine as control
  • Drug low dose Methylprednisolone
    Methylprednisolone 0.5mg/kg ivgtt qd
  • Drug Moderate dose Methylprednisolone
    Methylprednisolone 1.0mg/kg ivgtt qd

Primary outcome measures

  • 28-day all cause mortality [Time frame: 28 days from inclusion]

Eligibility criteria

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 adenovirus etiology: at least one positive nucleic acid test (PCR) or next-generation sequencing (NGS) result for adenovirus 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07152600 · 2025-I2M-C&T-B-090A

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗