Mpox, Smallpox Mpox, Smallpox
Conditions
Interventions
Administer cidofovir on days 0, 7, and 21. Cidofovir 5 mg/kg is dissolved in 100 ml saline and infused intravenously over 1 hour. To reduce cidofovir nephrotoxicity, saline infusion is started 1 to 2
Sponsors
Morioka Shinichiro
Ohmagari Norio
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. those who have been diagnosed with Mpox or smallpox 2. who have given written consent to participate in the study 3. who are between 18 and 60 years of age at the time of consent 4. who consent to inpatient treatment with cidofovir for up to 30 days after the start of cidofovir administration 5. patients with severe Mpox or severe high-risk Mpox (but need not apply in the case of smallpox patients)
Exclusion criteria
Exclusion criteria: 1. Patients with renal insufficiency (serum creatinine level > 1.5 mg/dl, creatinine clearance 100 mg/dl, urine protein qualitative = > 2+). 2. Patients who are receiving or have received within 7 days drugs with potential nephrotoxicity (drugs with potential nephrotoxicity: aminoglycoside injection (tobramycin, gentamicin, amikacin, etc.), amphotericin B, foscarnet, pentamidine injection, vancomycin, non-steroidal anti-inflammatory drugs, etc.). 3. Patients who are receiving or have received brincidofovir within 7 days. 4. Patients with a history of hypersensitivity to cidofovir 5. Patients who have had hypersensitivity reactions to probenecid. 6. Patients with allergy to sulfa drugs 7. Patients with kidney stone disease 8. Patients with blood disorders 9. Pregnant women 10. Nursing patients 11. Patients deemed inappropriate for inclusion (Diabetics and others)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with a Ct value of 40 or higher on skin sample PCR testing at the site of the skin rash 14 days after study inclusion | — |
Secondary
| Measure | Time frame |
|---|---|
| Mortality 14 to 30 days after study inclusion Viral load in blood, throat swabs, skin, and urine 14, 21, 30, 60, and 120 days after study inclusion Duration of fever of at least 37.5 degrees since study entry Occurrence of adverse events from study inclusion Performance status at study entry, 14 days, and 30 days (Lying in bed, able to leave bed for a short time, able to leave bed completely) | — |
Contacts
Public ContactSho Saito
Japan Institute for Health Security(JIHS)
Outcome results
None listed