Phase
Condition
Hiv
Lung Disease
Treatment
Xpert® MTB/XDR
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Ambulant adults ≥ 18 years of age
Newly diagnosed PTB patients receiving less than 5 days of treatment since newdiagnosis:
Cohort 1: < 5 days of DR-TB treatment
Cohort 2: < 5 days of INH mono-resistant TB treatment preceding study entry forthe current TB episode, or
Sputum positive (smear and or culture) TB patients classified as failing first linetreatment
Any currently available Nucleic Acid Amplification Tests for drug-resistancedetection changes/assay positive for M.tb infection with: Cohort 1: at least Rifampicin resistance Cohort 2: Rifampicin susceptibleco-occurring with INH, fluoroquinolone, ethionamide or aminoglycoside resistance (detected by Xpert XDR) occurring alone or in combination
Capacity to provide informed consent
HIV infected and uninfected participants are allowed in the study. Participantsalready on ART will be allowed in the study provided the ART regimen in use has nocontraindications to the proposed TB drug regimen
Willing to have samples collected, stored indefinitely, and used for researchpurposes
Able to provide reasonable proof of identity (to satisfaction of study team member)at or prior to enrolment
Exclusion
Exclusion criteria:
Has a known severe allergy to any of the BPaL component drugs
Has DST showing infection with a strain resistant to any of the component drugs
Has TB meningitis, other central nervous system TB, or TB osteomyelitis; or
Is pregnant or breastfeeding
Is unable to take oral medications
Persons with any other medical condition, precluding study participation based oninvestigator judgement
Any co-existing condition that in the opinion of the attending clinician renders theparticipant unsuitable for participation in the study
Co-enrolment in other interventional research studies
Study Design
Study Description
Connect with a study center
Ethiopian Public Health Institute (EPHI)
Gulele, Addis Ababa
EthiopiaSite Not Available
Institute of Human Virology Nigeria
Yaba, Lagos State
NigeriaSite Not Available
CAPRISA Springfield Research Clinic
Durban, KwaZulu-Natal 4091
South AfricaSite Not Available
Clinical HIV Research Unit (CHRU), WITS Health Consortium
Bethelsdorp, Port Elizabeth 6200
South AfricaSite Not Available

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