CTRI/2023/12/060938尚未招募1 期
Phase I Study of the Pharmacokinetics, Safety, and Acceptability of a Single Dose of Pretomanid Added to an Optimized Background Regimen in Children with Rifampicin-Resistant Tuberculosis
IH DAIDS0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
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
- •Assigned female sex at birth, as determined by the site investigator based on participant and parent/guardian report and available medical records
- •Age less than 18 years of age at entry
- •Weight greater than or equal to 4 kg at entry
- •Has confirmed or probable intrathoracic (pulmonary) RR-TB and/or any form of extrathoracic (extrapulmonary) RR-TB (other than stage 2 or 3 TB meningitis, which is exclusionary)
- •Confirmed intrathoracic (pulmonary) RR-TB, based on chest radiograph and/or symptoms consistent with TB, and/or any forms of extrathoracic TB, with all of the following, as determined by the site investigator based on medical records:
- •Microbiological confirmation of M. tuberculosis from any clinical specimen by either culture or molecular methods
- •Rifampicin resistance demonstrated by genotypic (molecular) or phenotypic methods
- •Documented clinical decision to treat for RR-TB
- •Probable intrathoracic (pulmonary) RR-TB, based on chest radiograph and/or symptoms consistent with TB, and/or any form of extrathoracic TB, with both of the following, as determined by the site investigator based on medical records:
- •Documented exposure to a source case with bacteriologically-confirmed intrathoracic rifampicin-resistant TB
- •Documented clinical decision to treat for RR-TB
- •Initiated an appropriate TB OBR treatment regimen as per routine treatment decision, at least two weeks prior to entry, as determined by the site investigator based on medical records, and is tolerating the regimen well at entry, in the opinion of the site investigator
- •Has normal, grade 1, or grade 2 results for all of the following at screening
- •Absolute neutrophil count
- •Estimated glomerular filtration rate (eGFR; bedside Schwartz formula)
- •Has normal or grade 1 results for all of the following at screening
- •Alanine aminotransferase (ALT)
- •Total bilirubin
- •Has a Karnofsky score greater than or equal to 50% for participants 16 years of age and older or Lansky play score greater than or equal to 50% for participants less than 16 years of age, at screening
排除标准
- •Has tuberculosis meningitis Stage 2 or 3, as determined by the site investigator based on medical records
- •Receipt of any of the following, within 14 days prior to entry, as determined by the site investigator based on participant/parent/guardian report and available medical records
- •Any prohibited medication (see protocol for listing)
- •For participants living with HIV: ritonavir-boosted protease inhibitors (e.g., ritonavir-boosted lopinavir, ritonavir-boosted darunavir), atazanavir, nevirapine etravirine, efavirenz, or cobicistat
- •Receipt of any investigational agent or device within 28 days prior to entry, as determined by the site investigator based on participant/parent/guardian report and available medical records
- •Has any of the following as determined by the site investigator based on participant/ parent/guardian report and available medical records
- •Clinical evidence of acute hepatitis A, B, C, or chronic hepatitis B or C
- •Significant cardiac arrhythmia that requires medication or increases the risk for Torsade de Pointes
- •Known allergy or hypersensitivity to pretomanid or other nitroimidazole compounds
- •Known porphyria
- •Currently breastfeeding an infant at entry, as determined by the site investigator based on participant/parent/guardian report
- •Exposed to pretomanid through breast milk within seven days prior to entry (i.e., mother receiving pretomanid and breastfeeding a potential participant), as determined by the site investigator based on parent/guardian report
- •Has any documented or suspected clinically significant medical condition or any other condition that, in the opinion of the site investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives
研究者
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