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(904) 244-0411

STOMP study

  • Status
    Accepting Candidates
  • Age
    7 Years - 60 Years
  • Sexes
    All
  • Healthy Volunteers
I'm interested
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Description

Phase 3, randomized, placebo-controlled, double-blind trial of tecovirimat for the treatment of human monkeypox virus (HMPXV) disease (Arm A and B). The study will also include a cohort of people (Arm C) who will receive open-label tecovirimat. Duration is 57 days, sample size 530 Arms A+B ; Arm C sample size not specified.

Details

Protocol number CED000000716

Eligibility

Laboratory-confirmed or presumptive HMPXV infection:

Laboratory-confirmed HMPXV infection is defined as determined by PCR, culture, or antigen test obtained from a sample collected from a skin lesion, oropharynx, or rectal swab obtained within 7 days prior to study entry

OR

Presumptive diagnosis:

• Skin lesion(s), mucosal lesion(s) or proctitis consistent with a high probability of HMPXV in the opinion of the site investigator

AND

• Sexual contact with 1 or more persons in the 21 days prior to symptom onset or close exposure to another person known to be infected with HMPXV.

OR

• Neonates (

Lead researcher

  • Mobeen H Rathore, MD, CPE, FACPE, FIDSA, FAAP, FAAP
    Pediatric Infectious Diseases Physician
    Languages: Urdu, Punjabi

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.