TASK 011-RPT-Crush:Relative bioavailability of three generic rifapentine and isoniazid compounds when manipulated in adults with latent tuberculosis: a bridge to paediatric dosing needs (RPT CRUSH”)

Stellenbosch University0 个研究点目标入组 24 人开始时间: 2022年10月19日最近更新: 2024年3月4日

适应症

试验速览

暂无简介。

•1.Written informed consent
•2.Able/willing to comply with the protocol requirements
•3.Aged between 18 and 65 years
•4.Documented recent TB exposure
•5.Evidence of TB infection (positive IGRA or TST <3 months prior to enrolment)
•6.Body weight =40kg and = 90 kg
•7.If of child-bearing potential, agree to use effective birth-control measures throughout the study.

•1.Diseases or conditions in which use of RPT/INH contraindicated;
•2.Known hypersensitivity or intolerance to RPT or INH;
•3.Recent TB exposure to drug-resistant TB
•4.Confirmed or suspected active TB
•5.HIV infection;
•6.Active chronic hepatitis B (HBsAg positive)
•7.Females who are pregnant, breastfeeding, or planning to conceive a child within the study period
•8.Laboratory abnormalities at screening; including anemia, leukopenia, thrombopenia, renal failure or hepatitis.
•9.Use of any prohibited medication
•10.Current participation in any other intervention trial of a therapeutic agent
•11.Screening drug test positive for amphetamines/methamphetamines, opioids, methaqualone, benzodiazepines
•12.Self-reported alcohol use exceeding 28 units per week for men, or 21 units for women
•13.Clinically significant diseases/abnormalities that might compromise safety of the participant/interpretability of data.

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