Whole Blood Bactericidal Activity (WBA) Against Mycobacterium Tuberculosis of Rifampicin in Healthy Volunteers
NCT02387242 · Status: SUSPENDED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2017-04-13
Summary
The purpose of this study is to evaluate the bactericidal activity against Mycobacterium tuberculosis of standard and high doses of rifampicin. Pharmacokinetics (PK) and Whole blood Bactericidal Activity (WBA) will be measured in healthy volunteers following a single dose of rifampicin at standard dose (10mg/kg) or at high dose (20mg/kg or 30mg/kg).
Conditions
Interventions
- DRUG
-
Rifampicin
Single oral dose of rifampicin
Sponsors & Collaborators
-
National University Hospital, Singapore
lead OTHER
Principal Investigators
-
Nicholas Paton · National University Hospital, Singapore
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-02-28
- Primary Completion
- 2017-12-31
- Completion
- 2017-12-31
Countries
- Singapore
Study Locations
More Related Trials
-
Accuracy and Consequences of Using Trial-of-antibiotics for TB Diagnosis (ACT-TB Study)
NCT03545373 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis
NCT07209761 ·Status: RECRUITING ·Phase: PHASE3
-
TMC207 +/- Rifabutin/Rifampin
NCT01341184 ·Status: COMPLETED ·Phase: PHASE1
-
EBA, Safety and Tolerability of Sanfetrinem Cilexetil
NCT05388448 ·Status: COMPLETED ·Phase: PHASE2
-
Pharmacokinetics and Pharmacodynamics of High Versus Standard Dose Rifampicin in Patients With Pulmonary Tuberculosis
NCT00760149 ·Status: COMPLETED ·Phase: PHASE2
-
TBTC Study 31: Rifapentine-containing Tuberculosis Treatment Shortening Regimens
NCT02410772 ·Status: COMPLETED ·Phase: PHASE3
-
Assessment of the Safety, Tolerability, and Effectiveness of Rifapentine Given Daily for LTBI
NCT03474029 ·Status: RECRUITING ·Phase: PHASE2/PHASE3
-
Evaluation of PATHFAST-LAM as a Tuberculosis Treatment Monitoring Tool in Kenya
NCT07157904 ·Status: NOT_YET_RECRUITING
-
Pharmacokinetics, Safety and Tolerability of Escalating Rifapentine Doses in Healthy Volunteers
NCT01162486 ·Status: COMPLETED ·Phase: PHASE1
-
Rifapentine Plus Moxifloxacin for Treatment of Pulmonary Tuberculosis
NCT00728507 ·Status: TERMINATED ·Phase: PHASE2
-
Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis (CL-010)
NCT00944021 ·Status: COMPLETED ·Phase: PHASE2
-
Trial of High-Dose Rifampin in Patients With TB
NCT01408914 ·Status: COMPLETED ·Phase: PHASE2
-
High-dose Rifampicin for the Treatment of Tuberculous Meningitis: a Dose-finding Study
NCT02169882 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
PA-824-CL-007: Phase IIa Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis
NCT00567840 ·Status: COMPLETED ·Phase: PHASE2
-
Performance of Xpert MTB/RIF and XDR Assay for Diagnosis of Pulmonary Tuberculosis and Resistant Pulmonary TB
NCT06392594 ·Status: NOT_YET_RECRUITING
-
Drug Exposure and Safety of a Shorter Tuberculosis Treatment Based on High-Dose Rifampicin and Pyrazinamide
NCT04694586 ·Status: SUSPENDED ·Phase: PHASE2
-
Doxycycline in Human Pulmonary Tuberculosis
NCT02774993 ·Status: COMPLETED ·Phase: PHASE2
-
Phase 1, Open Label, Two Arm, Fixed Sequence Study to Evaluate the Effect of Rifampin and Rifabutin on GSK1349572 Pharmacokinetics in Healthy Male and Female Volunteers
NCT01231542 ·Status: COMPLETED ·Phase: PHASE1
-
Sensitivity and Specificity of Xpert MTB/RIF Ultra
NCT06058065 ·Status: NOT_YET_RECRUITING
-
Phase 2a Study of PBTZ169
NCT03334734 ·Status: TERMINATED ·Phase: PHASE2
-
Development of Automated Molecular Diagnostic Platform for Tuberculosis Diagnosis (New Assay TB)
NCT04988984 ·Status: UNKNOWN
-
Early Bactericidal Activity (EBA) of SQ109 in Adult Subjects With Pulmonary TB
NCT01218217 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy of High Dose Rifampicin in Tuberculosis (TB)-HIV Co-infected Patients on Efavirenz- or Dolutegravir-based Antiretroviral Therapy
NCT03982277 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of the Safety, Tolerability, and Absorption, Metabolism, and Excretion of PA-824 in Healthy Adult Male Subjects.
NCT03202693 ·Status: COMPLETED ·Phase: PHASE1
-
NexGen EBA Radiologic and Immunologic Biomarkers of Sterilizing Drug Activity in Tuberculosis
NCT02371681 ·Status: COMPLETED ·Phase: PHASE2