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Clinical Trial Summary

In this open-labeled, randomized clinical trial, the Investigator will assess the safety and pharmacokinetics (PK) of model-optimized doses of rifampicin (RIF) with or without levofloxacin (LEVO) given to children as part of multidrug treatment for tuberculous meningitis (TBM) versus standard treatment. The Investigators will also assess functional and neurocognitive outcomes by treatment group, as measured by the Pediatric Modified Rankin Score (MRS) and the Mullen Scales of Early Learning (MSEL), respectively.


Clinical Trial Description

Open-label, randomized clinical trial in three treatment groups. Patients with probable or definite TB meningitis (TBM) will all receive isoniazid and pyrazinamide at standard doses for 8 weeks. Arm 1 participants will receive high-dose rifampicin plus ethambutol (EMB) at standard doses for 8 weeks. Arm 2 participants will receive high-dose rifampicin plus levofloxacin for 8 weeks. Arm 3 participants will receive rifampicin plus ethambutol at standard doses for 8 weeks (control arm). Patients will be screened to confirm TBM diagnosis, will receive 8 weeks of study treatment, and then will receive isoniazid (INH)/rifampicin for an additional 40 weeks, to complete 12 months of TBM treatment. All participants will receive oral steroids. PK sampling will be performed within first week and 6 (+/- 2) weeks following treatment initiation. Participants will have scheduled follow-up visits to assess safety and clinical status. In addition, functional and neurocognitive outcomes up to 18 months following treatment initiation will be assessed. Interim PK and safety analyses will be performed to ensure dosing is producing predefined PK targets and safety is acceptable. It is anticipated that a majority of children will be hospitalized for the initial 2-8 weeks of the study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02958709
Study type Interventional
Source Johns Hopkins University
Contact
Status Completed
Phase Phase 1/Phase 2
Start date February 22, 2017
Completion date November 15, 2020

See also
  Status Clinical Trial Phase
Completed NCT04021121 - Adjunctive Linezolid for the Treatment of Tuberculous Meningitis Phase 2
Completed NCT03537495 - Pharmacokinetic Study of Linezolid for TB Meningitis Phase 2
Not yet recruiting NCT06446245 - Adjunctive Doxycycline for Central Nervous System Tuberculosis Phase 2
Completed NCT02169882 - High-dose Rifampicin for the Treatment of Tuberculous Meningitis: a Dose-finding Study Phase 2/Phase 3