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Trial · NCT04145258

Registered outcomes27

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

ListOutcomeTime frameDescription
PrimaryRate of all-cause deathUp to 40 weeks
SecondaryRate of all-cause deathUp to 8 weeks
SecondaryRate of all-cause death or loss to follow-upUp to 40 weeks
SecondaryRate of new central neurological event or aggravation of a central neurological event existing at baselineUp to 40 weeks
SecondaryRate of grade 3-4 adverse events (DAIDS adverse events grading table)Up to 40 weeks
SecondaryRate of serious adverse eventsUp to 40 weeks
SecondaryRate of solicited treatment related adverse eventsUp to 40 weeks
SecondaryPercentage of patients with disability40 weeks
SecondaryM. tuberculosis culture conversion rate1 week and 4 weeks
SecondaryTime to culture positivityUp to 40 weeks
SecondaryTime to first hospital dischargeUp to 40 weeks
SecondaryCost-effectiveness incremental ratio of trial interventionsUp to 40 weeks
SecondaryPrevalence of resistance to anti-TB drugs among patients with positive culture at inclusionUp to 40 weeks
SecondarySubset of patients: In vitro bactericidal activity of anti-TBM treatment1 week and 4 weeks
SecondarySubset of patients: Maximum Plasma Concentration [Cmax] of rifampicin and linezolid1 week and 4 weeksPlasma Cmax, cerebrospinal fluid \[CSF\] Cmax, and plasma/CSF Cmax ratio
SecondarySubset of patients: Minimum Plasma Concentration [Cmin] of rifampicin and linezolid1 week and 4 weeksPlasma Cmin, cerebrospinal fluid \[CSF\] Cmin, and plasma/CSF Cmin ratio
SecondarySubset of patients: Area Under the Curve [AUC] of rifampicin and linezolid1 week and 4 weeksPlasma AUC, cerebrospinal fluid \[CSF\] AUC, and plasma/CSF AUC ratio
SecondarySubset of patients: Time for maximal concentration [Tmax] of rifampicin and linezolid1 week and 4 weeksPlasma Tmax, cerebrospinal fluid \[CSF\] Tmax, and plasma/CSF Tmax ratio
SecondarySubset of patients: Half-life (t1/2) of rifampicin and linezolid1 week and 4 weeksPlasma t1/2, cerebrospinal fluid \[CSF\] t1/2, and plasma/CSF t1/2 ratio
SecondaryHIV-infected participants: Rate of new AIDS-defining illnessesUp to 40 weeks

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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.

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