PER-014-22招募中2 期
A Phase II, Prospective, Randomized, Multicenter Trial to Evaluate the Efficacy and Safety/Tolerability of Two Linezolid Dosing Strategies in Combination with a Short Course Regimen for the Treatment of Drug-Resistant Pulmonary Tuberculosis.
Instituto Nacional de Alergias y Enfermedades Infecciosas NIAID0 个研究点目标入组 8 人开始时间: 2023年6月26日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 8
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
- •1. Aged =18 years of age at screening.
- •2. Newly diagnosed pulmonary drug-resistant TB (DR-TB), with resistance to at least RIF as determined by either genotypic (such as Cepheid Xpert MTB/RIF, Cepheid Xpert MTB/RIF Ultra, Hain GenoType MTBDRplus, Hain GenoType MTBDRsl, or other WHO-endorsed rapid diagnostic test) or with the results of phenotypic drug susceptibility testing (DST) from a sputum specimen collected within 60 days prior to entry.
- •3. HIV-1 infection status documented as either absent or present.
- •4. For participants living with HIV, either currently on an ART regimen or willing and able to start ART within 30 days after entry.
- •5. Efavirenz or etravirine must be discontinued prior to a participant’s starting anti-TB medications. For participants on efavirenz or etravirine, they must be willing and able to discontinue these at least 7 days prior to initiating study TB medications.
- •6. For participants living with HIV, CD4+ cell count =50 cells/mm3 obtained within 60 days prior to study entry
- •7. For females of reproductive potential, negative serum or urine pregnancy test within 7 days prior to entry
- •8. Females of reproductive potential who are participating in sexual activity that could lead to pregnancy must agree to use two of the following forms of birth control while receiving TB study medications and for 30 days after stopping study medications : male or female condoms, diaphragm or cervical cap (with spermicide, if available), intrauterine device (IUD) or intrauterine system (IUS), and hormone-based birth control (e.g., oral contraceptives, Depo-Provera, NuvaRing, implants).
- •9. Appropriate laboratory values as determined by the study doctor obtained within 14 days prior to entry
- •10. Karnofsky performance score =50 within 30 days prior to entry.
- •11.Ability and willingness of candidate and/or legal guardian/representative to provide informed consent and meet requirements for the study.
- •12. Chest X-ray obtained within 30 days prior to entry.
排除标准
- •1. Documentation of clinically significant (as judged by the site investigator) active infections (including HIV-related opportunistic infections) other than TB and HIV requiring treatment within 30 days prior to entry.
- •2. Evidence of clinically significant (as judged by the site investigator) metabolic, gastrointestinal, cardiovascular, musculoskeletal, ophthalmological, pulmonary, neurological, psychiatric, endocrine diseases, malignancy, or other abnormalities (other than the indication being studied) that would interfere with study medications or procedures
- •3. Inability to take oral medications.
- •4. Suspected or documented TB involving the central nervous system, clinically significant renal TB or TB pericarditis, or current extrapulmonary TB involving other organ systems that might interfere with study medications or procedures, as judged by the site investigator
- •5. Prior treatment with LZD, DLM, BDQ, or CFZ at any time in the past for an episode of DR-TB that is not the qualifying episode or treatment for more than 7 cumulative days with one or more of LZD, DLM, BDQ, or CFZ within 30 days prior to entry for the qualifying episode of DR-TB.
- •6. History of allergy or hypersensitivity to any of the study drugs or medications in the same class as the study drugs
- •7. Known or suspected current alcohol and/or drug abuse that is, in the opinion of the site investigator, sufficient to compromise the safety and/or cooperation of the participant
- •8. Receipt of any investigational drugs within 60 days prior to entry.
- •9. Known history of prolonged QT syndrome or current QTcF interval >450 ms on screening ECG.
- •10. Known history of clinically significant cardiac arrhythmia requiring medication or clinically significant ECG abnormality, in the opinion of the site investigator, within 60 days prior to entry, including but not limited to second or third degree atrioventricular (AV) block or prolongation of the QRS complex interval over 120 ms.
- •11. Pregnancy or current breastfeeding, or intent to become pregnant and/or breastfeed while on study treatment.
- •12. Current use of monoamine oxidase inhibitors or use within 30 days prior to entry.
- •13. Current use of serotonergic agents including SSRI/SNRI antidepressants or prior use within 30 days prior to entry
- •14. Known history of optic neuropathy of any grade as diagnosed by an ophthalmologist
- •15. Current peripheral neuropathy Grade =2.
- •16. Weight <35 kg
- •17. Currently taking other prohibited medications.
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