Table 1.

PK/safety studies in children with MDR-TB disease

Study	Intervention	Design	Target Population	Aim	Sample Size
MDR-PK 1	PK and safety of levofloxacin, moxifloxacin, ofloxacin, amikacin, high-dose isoniazid, ethionamide, Para-aminosalicylic acid, terizidone, cycloserine at routine doses	Observational cohort	Children 0–15 years old	PK, drug-drug interactions and safety in children treated for MDR-TB with/without HIV co-infection.	318
MDR-PK 2	Moxifloxacin, levofloxacin and linezolid	Observational cohort	Children 0–15 years old	PK, drug-drug interactions and safety in children treated for MDR-TB with/without HIV co-infection.	100
Jansen C211	Bedaquiline in combination with other second-line agents	Open label, single arm	HIV-uninfected children ages 0–1 years old; 2–4 years; 5–11 years; 12–17 years	PK, safety and anti-mycobacterial activity of bedaquiline in combination with other second line drugs	60
IMPAACT P1108	Bedaquiline in combination with other second-line agents	Open label, single arm	HIV-infected and uninfected children with MDR-TB under an FDA IND	Dose finding and safety study of bedaquiline in combination with other second line drugs	Not yet enrolling
Otsuka 232 and 233	Delamanid	Open label, multiple-dose	HIV-uninfected children 0–17 years old	PK, safety and tolerability of delamanid	36
IMPAACT 2005	All-oral, injectable-sparing, delamanid-based MDR-TB regimen	Open label, single-arm clinical trial	Children 0 – <3 years; 3 – <6 years; 6 – <12 years; 12 – <18 years	PK, safety and tolerability of intervention regimen; assess effect of HIV and ART on delamanid PK	Not yet enrolling