CTRI/2019/06/019547进行中（未招募）4 期
Itraconazole in the Management of Superficial Fungal Infections in India. A Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
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
入选标准
- •Each potential participant must satisfy all of the following criteria to be enrolled in the study:
- •1. Clinically diagnosed with T. cruris or T. corporis with or without history of treatment
- •2. Are prescribed itraconazole at 200 mg/day orally for the treatment of T. cruris or T.
- •corporis and taken once a day
- •3. 18 to 60 years of age (both inclusive)
- •4. Must sign an informed consent form (ICF) indicating that he or she understands the
- •purpose of, and procedures required for, the study and is willing to participate in the
- •5. A woman of childbearing potential must have a negative highly sensitive serum
- •(B-human chorionic gonadotropin [B-hCG]) at screening on Day -3 to 0 before start of
- •study drug.
- •6. A woman must be (as defined in Section 10, Appendix 10.3, Contraceptive Guidance
- •and Collection of Pregnancy Information)
- •a. Not of childbearing potential
- •b. Of childbearing potential and:
- •Practicing a highly effective method of contraception (failure rate of <1% per year when
- •used consistently and correctly) and agrees to remain on a highly effective method while
- •receiving study drug and until 30 days after last dose (ie, the end of relevant systemic
- •exposure). Examples of highly effective methods of contraception are located in
- •Appendix 10.3, Contraceptive and Barrier Guidance and Collection of Pregnancy
- •Information.
- •Typical use failure rates may differ from those when used consistently and correctly
- •7. A male participant must wear a condom when engaging in any activity that allows for
- •passage of ejaculate to another person. A male participant must agree not to donate
- •sperm for the purpose of reproduction during the study and for a minimum 90 days after receiving the last dose of study drug.
排除标准
- •Any potential participant who meets any of the following criteria will be excluded from
- •participating in the study:
- •1. History of ventricular dysfunction such as CHF or receiving treatment for CHF, liver
- •or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal,
- •endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic
- •disturbances at any time prior to the start of study
- •2. Known achlorhydria or on treatment of gastric acidity
- •3. Presence of other dermatoses, e.g. psoriasis, seborrhoeic or atopic dermatitis
- •4. Infected with organism with known or established resistance to itraconazole
- •5. Co-existing fungal infection of other body area
- •6. Known allergies, hypersensitivity, or intolerance to itraconazole or its excipients or to
- •any other azole.
- •7. Pregnant, or breastfeeding women
- •8. Women of childbearing potential not on any effective contraceptive precautions or
- •planning to become pregnant while enrolled in this study or within 2 weeks after the
- •last dose of study drug
- •9. Taking drugs that are CYP3A4 substrates (see Section 6.5, Concomitant Therapy
- •before the planned first dose of study drug for disallowed therapies)
- •10. Received oral itraconazole within 14 days before screening
- •11. Use of other systemic antifungal or corticosteroid therapy unless such therapy has
- •been discontinued for at least 30 days prior to the start of therapy
- •12. Use of topical antifungal or corticosteroid therapy within 14 days before screening
- •13. If at criteria of the treating physician there is a proven or suspected infection with
- •Fusarium species, mucorales or other agents considered not susceptible to
- •itraconazole
- •14. Received an investigational drug (including investigational vaccines) or used an
- •invasive investigational medical device within 3 months before the planned first dose
- •of study drug or is currently enrolled in an investigational study
- •15. Plans to father a child while enrolled in this study or within 2 weeks after the last dose
- •of study drug
- •16. Any condition for which, in the opinion of the investigator, participation would not be
- •in the best interest of the participant (eg, compromise the well-being) or that could
- •prevent, limit, or confound the protocol-specified assessments
研究者
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