Pharmacokinetics Clinical Trial
Official title:
Comparison of Intensive Treatment Regimens and Standard Treatment Regimen for Tuberculous Meningitis: Pharmacokinetics, Pharmacodynamics and Tolerability Study
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 decade, partly due to the HIV epidemic. Without treatment,
virtually all patients with TB meningitis will die. With the current treatment regimens, TBM
is fatal in approximately 30-50% of cases, and responsible for severe disability in a
similar proportion of survivors.
Worldwide, Indonesia the third highest case load of tuberculosis with an estimated 500,000
new patients / year. Representative data are lacking, but it is clear that TBM is a growing
problem. For instance, in Hasan Sadikin Hospital, the top-referral hospital for West Java
Province (population 40 million), Indonesia, 40-50 cases of TBM were treated yearly in the
late 90's compared to approximately 100 in recent years.
There is very little evidence for the current treatment regimen for TBM, which dates back to
the late 60's. Therefore, there is an urgent need to evaluate intensified treatment of TBM
in randomized trials. We hypothesize that higher dose rifampicin, moxifloxacin (possibly
also at high dose), or both will improve outcome of TBM. To determine the experimental
regimen(s) which should be compared with current regimen in phase 3 trials, we want to
evaluate pharmacokinetic aspects and toxicity of candidate regimens in a phase 2 clinical
trial in 60 patients with TBM in Indonesia.
n/a
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04092725 -
Study to Evaluate the Effect of SCY-078 on the PK of Dabigatran in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT04181008 -
Pharmacokinetics of Amiloride Nasal Spray in Healthy Volunteers
|
Early Phase 1 | |
| Active, not recruiting |
NCT03258151 -
Association of Genetic Polymorphisms With Docetaxel-based Chemotherapy Toxicities in Chinese Solid Tumor Patients
|
||
| Completed |
NCT04406415 -
Oral Nafamostat in Healthy Volunteers
|
Phase 1 | |
| Not yet recruiting |
NCT05421312 -
Periarticular Penetration of Cefazolin and Clindamycin in Second Stage Revision Arthroplasty of the Hip
|
Phase 4 | |
| Completed |
NCT02534753 -
A Pharmacokinetics Study of Intravenous Ascorbic Acid
|
Phase 1 | |
| Completed |
NCT01682408 -
Assess Pharmacokinetics of Fostamatinib in Fed and Fasted State in Combination With Ranitidine to Assess Bioavailability
|
Phase 1 | |
| Completed |
NCT01976078 -
Development of Voriconazole Pharmacokinetics and Metabolism in Children and Adolescents
|
N/A | |
| Completed |
NCT01636024 -
To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Doses of Inhaled AZD7594
|
Phase 1 | |
| Completed |
NCT01208155 -
Study in Healthy Males to Assess Bioavailability of 4 Different Fostamatinib Tablets
|
Phase 1 | |
| Completed |
NCT01214941 -
Effect of Itraconazole and Ticlopidine on the Pharmacokinetics and Pharmacodynamics of Oral Tramadol
|
Phase 4 | |
| Completed |
NCT01415102 -
A First In Human Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Single Inhaled Doses Of PF-05212372.
|
Phase 1 | |
| Completed |
NCT01260025 -
Tolerability and Pharmacokinetics of M2ES in the Treatment of Advanced Solid Tumor
|
Phase 1 | |
| Completed |
NCT00730145 -
A Single Dose Study Investigating The Elimination Of PD-0332334 In Patients Receiving Regular Hemodialysis
|
Phase 1 | |
| Completed |
NCT00856570 -
A Clinical Study to Determine the Effect of YM178 on the Pharmacokinetics of Warfarin in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT00983242 -
Drug-Drug Interaction Between Colchicine and Verapamil ER
|
Phase 1 | |
| Completed |
NCT00746499 -
Pharmacokinetic Study of Raltegravir in Healthy Premenopausal Women.
|
Phase 1 | |
| Completed |
NCT00747721 -
Pharmacokinetics of Dexmedetomidine During Prolonged Infusion in ICU
|
Phase 1 | |
| Completed |
NCT01055964 -
a Comparative Pharmacokinetic Study of Two Oral Formulations of Tacrolimus in Renal Allograft Recipients
|
Phase 3 | |
| Completed |
NCT00984009 -
A Drug-Food Interaction Study Between Colchicine and Grapefruit Juice
|
Phase 1 |