Status:
COMPLETED
Intensified Treatment Regimens for TB Meningitis: PK, PD and Tolerability Study
Lead Sponsor:
Universitas Padjadjaran
Collaborating Sponsors:
Radboud University Medical Center
Conditions:
Meningitis, Tuberculous
Pharmacokinetics
Eligibility:
All Genders
15+ years
Phase:
PHASE2
Brief Summary
Tuberculous meningitis (TBM) is the most lethal form of tuberculosis infection, and is diagnosed in approximately 5-10% of TB patients. The incidence of TBM has increased considerably during the last ...
Eligibility Criteria
Inclusion
- Tuberculous meningitis, diagnosed based on clinical and/or CSF criteria
- Age 15 years old or more
- Hospitalized for the treatment
Exclusion
- Pregnancy/lactation
- On TB treatment within 7 days before inclusion
- Elevated liver enzyme (\> 5x than normal values)
- Known hypersensitivity/intolerance to rifampicin or moxifloxacin
- Prolonged QTc interval in ECG or other detectable cardiac arrythmias, in the absence of hypokalemia
- Refusal to be included in the study
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01158755
Start Date
October 1 2010
End Date
June 1 2012
Last Update
June 7 2012
Active Locations (1)
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1
Hasan Sadikin General Hospital
Bandung, West Java, Indonesia, 40161