Patients positive for cytomegalovirus pp65 antigen
Conditions
Interventions
Serum concentrations of ganciclovir is measured approximately once a week after initiation of valganciclovir. The clearance of individual patients is estimated by Bayesian method using a previously re
Sponsors
Saegusa Jun
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Inpatients at department of rheumatology and clinical immunology, Kobe University Hospital 2. Patients treated with prednisolone of more than or equal to 0.5 mg/kg with/without immunosuppressive agents as initial therapy, or those who were transferred or referred to department of rheumatology and clinical immunology after initiation of immunosuppressive therapy and for whom equivalent initial treatment could be confirmed. 3. Patients aged 18 years or older at the time of consent acquisition 4. Patients for whom written informed consent has been obtained regarding their voluntary participation in this clinical study. 5. Patients who test positive for cytomegalovirus pp65 antigen and meet one of the following conditions Cytomegalovirus pp65 antigen is more than or equal to 10 /2 slides Cytomegalovirus pp65 antigen is more than or equal to 1/ 2 slides and less than or equal to 9 /2 slides, and retest result after 2 to 8 days was cytomegalovirus pp65 antigen is more than or equal to 5 /2 slides and higher than the initial value. 6. Patients without symptoms (e.g., fever, cough, dyspnea, abdominal pain, diarrhea, bloody stools, and dysopia) due to CMV infection 7. Patients who have not received VGCV at least 2 weeks before starting this clinical study
Exclusion criteria
Exclusion criteria: 1. Patients with dialysis 2. Patients with significant bone marrow suppression such as neutrophil count less than 500 /mm3 or platelet count less than 25,000 /mm3 3. Pregnant women or women who may be pregnant 4. Patients with allergies or other drug sensitivities to the valganciclovir, ganciclovir, acyclovir, or valacyclovir. 5. Patients with hemoglobin levels less than 8.0 g/dL 6. Patients taking probenecid 7. Patients that the investigator deems inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To estimate the ratio of achievement of negative cytomegalovirus antigenemia within 3 weeks without serious adverse event for patients who conducted reemptive therapy with valganciclovir for cytomegalovirus reactivation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Presence, type ,severity, and frequency of adverse event of oral valganciclovir 2. To estimete the difference in cytomegalovirus antigen levels at baseline and at weekly intervals after administration 3. To estimate the ratio of cytomegalovirus antigen levels to baseline at weekly intervals after the initiation of valganciclovir 4. Total dose of valganciclovir during pre-emptive therapy 5. Treatment period of valganciclovir for pre-emptive therapy | — |
Contacts
Public ContactKotaro Itohara
Kobe University Hospital
Outcome results
None listed