PER-060-22招募中3 期
A Randomized, Placebo-Controlled, Double-Blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Human Monkeypox Virus Disease
Instituto Nacional de Alergias y Enfermedades Infecciosas NIAID0 个研究点目标入组 35 人开始时间: 2023年9月15日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Inclusion Criteria (All participants; Arms A, B, and C)
- •1. 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
- •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.
- •2. HMPXV illness of <14 days duration immediately prior to study entry.
- •3. At least one active (not yet scabbed) skin lesion, mouth lesion, or proctitis with or without visible ulcers.
- •4. Non-pregnant people of reproductive potential must agree to use at least one effective means of contraception when engaging in sexual activities that can result in pregnancy, from the time of enrollment through the end of study participation. Acceptable methods of contraception include the following:
- •Abstinence
- •Hormonal contraception
- •Male or female condom
- •Diaphragm or cervical cap with a spermicide
- •Intrauterine device
- •5. Ability to provide informed consent (for those above the legal age of consent and those providing consent for minors) and assent (for those over the age of 7, but below the legal age of consent)
- •6. Additional Inclusion Criteria for Arms A and B
- •- Age =18 years at the time of study entry
- •7. Additional Inclusion Criteria for Arm C
- •Participants who meet the above entry criteria who also meet any of the following criteria will be registered to Arm C.
- •- Participants age <18 years at the time of study entry
- •- Those with severe HMPXV disease defined as having one or more of the following conditions:
- •Suspected or confirmed ocular involvement
- •Facial lesions on the malar, nose, or eyelid region
- •Confluent facial lesions
- •Hospitalization due to HMPXV infection or its complications
- •Lesions that require surgical intervention including debridement, urinary catheterization or sigmoidoscopy, or lesions extending below the dermis
- •- Those with or without severe disease and with one or more of the following will also be enrolled into Arm C:
- •Severe immunosuppression defined as:
- •o HIV with CD4 <200 cells/mm3 or plasma HIV-1 RNA >1000 copies/mL
- •o Generalized malignancy
- •o Solid organ transplantation
- •o Therapy with alkylating agents within 180 days prior to study entry
- •o Antimetabolites within 180 days prior to study entry
- •o Radiation therapy within 180 days prior to study entry
- •o Tumor necrosis factor inhibitors within 180 days prior to study entry
- •o High-dose corticosteroids (equivalent of 20 mg or greater of prednisone for at least 14 days) within 90 days prior to study entry
- •o Being a recipient with hematopoietic stem cell transplant <24 months post-transplant or =24 months but with graft-versus-host disease or disease relapse, or having autoimmune disease with immunodeficiency as a clinical component)
- •o Other severe immunosuppression in the opinion of the site investigator
- •Skin conditions placing the person at higher risk for disseminated infection as defined as:
- •o Atopic dermatitis
- •o Active exfoliative skin condition(s) such as eczema, burns, impetigo, active varicella zoster virus infection, psoriasis, or Da
排除标准
- •Exclusion Criteria (All participants; Arms A, B, and C)
- •1. Prior or concomitant receipt of tecovirimat (e.g., under an alternative access mechanism.
- •2. Planned initiation of intramuscular cabotegravir/rilpivirine during study drug administration or for two weeks following completion of study drug administration. Participants who are stable on long-acting intramuscular cabotegravir/rilpivirine may enroll.
- •3. Participants who, in the judgement of the investigator, will be at significantly increased risk as a result of participation in the study.
- •4. Participants who require intravenous dosing of tecovirimat
研究者
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