Paediatric single dose Pretomanid Pharmacokinetic study
- Conditions
- Health Condition 1: J984- Other disorders of lung
- Registration Number
- CTRI/2023/12/060938
- Lead Sponsor
- IH DAIDS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
Creatinine
Platelets
Absolute neutrophil count
Hemoglobin
Estimated glomerular filtration rate (eGFR; bedside Schwartz formula)
Has normal or grade 1 results for all of the following at screening
Alanine aminotransferase (ALT)
Lipase
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
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
Rifamycins
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method