Trial · NCT02169882
High-dose Rifampicin for the Treatment of Tuberculous Meningitis: a Dose-finding Study
NCT02169882, Phase 2, Phase 3, Completed, Universitas Padjadjaran
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. High-dose Rifampicin for the Treatment of Tuberculous Meningitis: a Dose-finding Study. Trials, record NCT02169882. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02169882
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- High-dose Rifampicin for the Treatment of Tuberculous Meningitis: a Dose-finding Study
- NCT number
- NCT02169882
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 60 participants, actual
- Lead sponsor
- Universitas Padjadjaran
- Conditions
- Tuberculosis, Meningeal
- Interventions
- Placebo, Rifampicin, Other TB drugs, Adjuvant dexamethasone
- First posted
- 2014-06-23
- Last updated
- 2017-06-01
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rifampicin concentrations in plasma and cerebrospinal fluid (CSF) | Day 2 (+/- 1) after administration of study drugs | The rifampicin concentrations in plasma are measured from blood samples that are obtained by intensive pharmacokinetic sampling at 6 sampling time points (h0, 1, 2, 4, 8, 12 post dose). CSF rifampicin concentration will be measured using CSF sample taken by means of lumbar puncture at hour 3-6 post dose at the same day of blood sampling. |
| Secondary | Rifampicin concentrations in plasma and CSF at steady-state | Day 10 (+/- 1) after starting treatment with study drugs | The rifampicin concentrations in plasma are measured from blood samples that are obtained by intensive pharmacokinetic sampling at 6 sampling time points (h0, 1, 2, 4, 8, 12 post dose). CSF rifampicin concentration will be measured using CSF sample taken by means of lumbar puncture at hour 3-6 post dose at the same day of blood sampling. |
| Secondary | Grade 3 and 4 and serious adverse events | Within 60 days | Determined by measurement of liver function, hematology, gastrointestinal intolerance and hypersensitivity at days 3, 7, 10, 14, 30, 45, and 60 |
| Secondary | Mortality | 180 days | |
| Secondary | Neurological response | Within 60 days | Neurological responses that show both improvement (e.g. time to resolution of comma, time to fever resolution) and worsening (time to development of neurological deficits) will be measured and recorded at days 3, 7, 30 and 60. |
| Secondary | Neuroradiological response | 60 days | Development of infarction or other complication of TBM will documented by performing and comparing brain MRIs that will be done within the first 5 day and 60 day (+/- 5 days) after randomization |
| Secondary | Resolution of blood and CSF inflammatory response | 7 days | Inflammatory response will be measured at day 0 and day 7 |
| Secondary | Sensitivity of GeneXpert for diagnosing TBM | Within 6 weeks | Every CSF sample from patients who come with suspicion of TBM will be inoculated in GeneXpert cartridge and standard culture measures (MODS), and the result will be compared. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02169882
GET https://conductscience.org/api/trials/v1/NCT02169882/registered