Mpox or Smallpox Mpox, Smallpox
Conditions
Interventions
In this study, cidofovir will be administered in com bination with probenecid.
Sponsors
Morioka Shinichiro
Ohmagari Norio
Japan Agency for Medical Research and Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In case of smallpox, the patient must satisfy 1) to 3) and 6). In the case of Mpox, all of 1) to 6) must be met. 1) Individuals who have given written consent to participate in research. 2) Persons who are between the ages of 18 and 60 at the time of consent. 3) Individuals who have been diagnosed with mpox or smallpox. However, smallpox is diagnosed when the agent is detected in a blister, pustule, crust, throat swab, or blood sample, and mpox is diagnosed when the agent is detected in a skin or mucosal lesion, blister contents, nasopharyngeal swab, or blood sample, nasopharyngeal swab, pharyngeal swab, anorectal swab, other mucosal swab, blood, urine, or other material appropriate to the test method, by any of the following methods. Direct observation of viral particles by electron microscopy Detection of pathogens by isolation and identification Detection of pathogen antigens by the fluorescent antibody method Detection of pathogen genes by PCR 4) Persons to whom tecovirimat is administered 5) Patients with severe mpox or severe high risk mpox. 6) Patients who agree to be hospitalized and treated with cidofovir for up to 30 days after initiation of treatment with cidofovir.
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 in the study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with a Ct value of 40 or higher on PCR testing of skin samples at the site of the rash 14 days after study entry. | — |
Secondary
| Measure | Time frame |
|---|---|
| -Mortality at 14 and 30 days post enrollment -Virus levels in blood, throat swabs, skin, and urine at 14, 21, 30, 60, and 120 days after enrollment -Duration of fever 37.5 degrees or higher after study entry -Adverse events since study entry -General condition (bedridden, briefly bedridden, or completely bedridden) at baseline, 14 days, and 30 days after baseline | — |
Contacts
Public ContactSho Saito
National Center for Global Health and Medicine
Outcome results
None listed