EBV infection
Conditions
Interventions
Intervention Group:Methylprednisolone Therapy
Control Group:Symptomatic Treatment
Sponsors
Zhejiang University School of Medicine Affiliated Children's Hospital
Eligibility
Sex/Gender
All
Age
0.5 Years to 18 Years
Inclusion criteria
Inclusion criteria: (1)At the time of randomization, the age should be >=6 months and 38°C) for >= 7 days. (3)Patients have a fever within 24 hours of enrollment, and the white blood cell count in the blood routine within 48 hours before and after enrollment is >=15×10^9/L, and the alanine aminotransferase (ALT) is more than twice the upper limit of the normal value of each center within 48 hours before and after enrollment. (4)Laboratory evidence of EBV infection (meeting any one of the following 5 criteria): 1. For those over 6 years old, L% >50% or L > 5×10^9/L; 2. Atypical lymphocytes >10%; 3. VCA-IgM and VCA-IgG are positive, and NA-IgG is negative; 4. VCA-IgM is negative, and low avidity VCA-IgG antibody is positive; 5. Serum EBV-DNA is positive. (5)The interval between the first appearance of EBV infection-related symptoms (fever, pharyngitis, eyelid swelling, lymphadenopathy) and the time of randomization is <=14 days. (6)Able to comply with all research procedures and able to complete the subject questionnaire as required by the trial (if necessary, the subject's guardian may assist in completing it). (7)The subject and their guardian are willing to voluntarily participate in the study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1)A history of previous EBV infection or chronic EBV infection. (2)A clear concurrent acute or chronic infection with other pathogens. (3)Concurrent severe complications of EBV (definitions are detailed in the study endpoints): Hemophagocytic syndrome, splenic rupture, acute liver failure, neurological complications (including encephalitis, aseptic meningitis, epilepsy, Guillain-Barré syndrome, and other peripheral neuropathies, multiple sclerosis, and acute disseminated encephalomyelitis, etc., central nervous system inflammatory demyelinating diseases), hematological complications (including neutropenia, severe thrombocytopenia, and severe hemolytic anemia), respiratory complications (pneumonia, grade III-IV laryngeal obstruction). (4)Concurrent other diseases affecting liver function: Hepatitis, fatty liver, drug-induced liver injury, alcoholic liver disease, autoimmune liver disease, genetic metabolic liver diseases, liver cancer, bile duct cancer, bile duct infections, and parasitic diseases of the bile ducts, etc. (5)Concurrent other severe underlying diseases and critical illnesses: Deformations that significantly affect organ function, severe malnutrition, immune deficiency or chromosomal abnormalities, inherited metabolic diseases, post-stem cell transplantation, post-solid organ transplantation, malignant tumors, autoimmune diseases, epilepsy, severe psychiatric history, respiratory failure, heart failure, shock, multi-organ dysfunction, etc. (6)Received glucocorticoids or other immunosuppressants or immunoglobulins or medications affecting liver function within 14 days. (7)Known contraindications to study-related drugs (ganciclovir, methylprednisolone) (including but not limited to): Allergy to study drugs, active peptic ulcers, recent gastrointestinal anastomosis, fracture or other trauma repair period, severe osteoporosis, herpes simplex keratoconjunctivitis and ulcerative keratitis/cornal ulcers, severe hypertension, severe diabetes, fungal infections, chickenpox, cataracts or glaucoma. (8)Participated in another clinical trial within 30 days and used any other clinical trial medication or devices. (9)Deemed unsuitable to participate in this clinical study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients who showed clinical improvement;The proportion of patients with severe complications due to EB virus infection;The proportion of patients with negative serum/plasma EBV nucleic acid; | — |
Secondary
| Measure | Time frame |
|---|---|
| the proportion of patients with normal white blood cell counts;The proportion of patients with normal body temperature;the proportion of patients with a decrease in alanine aminotransferase (ALT) levels compared to baseline;the proportion of patients with normal cellular immune indicators;the proportion of patients with normal liver and spleen enlargement;the time for all 6 symptoms (fever, pharyngitis, eyelid edema, lymph node enlargement, liver enlargement, and spleen enlargement) to resolve;each symptom to resolve;the time for alanine aminotransferase (ALT) to return to normal;the condition changes;The time to negativity of plasma/serum EBV-DNA;the change in viral load from baseline;Hospitalization costs;length of hospital stay; | — |
Countries
China
Contacts
Public ContactLisu Huang
Zhejiang University School of Medicine Affiliated Children's Hospital
Outcome results
None listed