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Trial · NCT01158755

Intensified Treatment Regimens for TB Meningitis: PK, PD and Tolerability Study

NCT01158755, Phase 2, Completed, Universitas Padjadjaran

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Intensified Treatment Regimens for TB Meningitis: PK, PD and Tolerability Study. Trials, record NCT01158755. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01158755

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Intensified Treatment Regimens for TB Meningitis: PK, PD and Tolerability Study
NCT number
NCT01158755
Status
Completed
Phases
Phase 2
Enrollment
60 participants, actual
Lead sponsor
Universitas Padjadjaran
Conditions
Meningitis, Tuberculous, Pharmacokinetics, Pharmacodynamics, Tolerability
Interventions
Moxifloxacin
First posted
2010-07-08
Last updated
2012-06-07

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryRifampicin and Moxifloxacin concentration in plasma and CSFPlasma drug concentration samplings at 0, 1, 2, 4, 6 and 24h post dose (6 time points). CSF samples at 2 time points.
On sampling day (one of the first 3 days of hospitalization), we will measure plasma and CSF drug concentration at several time points. Plasma drug concentration will be measured at 6 time points (hour 0, 1, 2, 4, 6 and 12). CSF drug concentration at 2 time points: (1) hour 3-6 post dose on the same blood sampling day and (2) within 5 days after the 1st day of TB drug administration, 1-3 hours after drug intake
SecondaryEarly and late mortality1st and 6th month of TB treatmentWe will measure early (within first month of TB treatment) and late (after 6 months of TB treatment) mortality

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.

PMIDListed asSource
23103177DERIVEDPubMed
25703312DERIVEDPubMed

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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/NCT01158755

GET https://conductscience.org/api/trials/v1/NCT01158755/registered