Pharmacokinetic Study to Evaluate Anti-mycobacterial Activity of TMC207 in Combination With Background Regimen (BR) of Multidrug Resistant Tuberculosis (MDR-TB) Medications for Treatment of Children/Adolescents Pulmonary MDR-TB
Last Updated August 7, 2024
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CR106371
OVERVIEW
-
Sexes Eligible for Study
all -
Age
years -
Phase
phase 22 -
Sites
Sites -
Status
Recruiting
SUMMARY
CONDITIONS
- Tuberculosis, Multidrug-Resistant
ELIGIBILITY
Inclusion Criteria:
* Participant must be a boy or girl, aged from birth (0 months) to less than (<) 18 years at screening. Participants in Cohort 4 who are <6 months of age must be greater than or equal to (>=) 37 weeks gestation at baseline
* Participant must weigh >3 kilogram
DETAILS
LOCATIONS
Country (6) | City or Province (8) | Status |
Mozambique | Maputo Hospital Geral da Polana Caniço |
RECRUITING
|
Philippines | Dasmarinas De La Salle Health Sciences Institute- DLSUMC |
RECRUITING
|
Philippines | Quezon City Lung Center Of The Philippines |
COMPLETED
|
Russia | Moscow First Moscow State Medical University n.a. I.M. Sechenov |
COMPLETED
|
South Africa | Durban THINK: Tuberculosis & HIV Investigative Network |
RECRUITING
|
South Africa | Port Elizabeth Wits Health Consortium |
RECRUITING
|
Uganda | Kampala Makerere University Lung Institute |
RECRUITING
|
Ukraine | Kiev State Institute Of Phthisiology And Pulmonology N.A. F.G. Yanovskiy Of Ams Ukraine |
COMPLETED
|
-25.96553, 32.58322
14.32944, 120.93667
14.6488, 121.0509
55.75222, 37.61556
-29.8579, 31.0292
-33.91799, 25.57007
0.31628, 32.58219
50.45466, 30.5238
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Corresponds to individual site.