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Phase I/II Randomized, Open-label Trial to Evaluate the PK, Safety, and Outcomes of Treatment Including High Dose Rifampicin +/- Levofloxacin vs Standard Treatment for Pediatric Tuberculous Meningitis (TBM)

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Trial Profile

Phase I/II Randomized, Open-label Trial to Evaluate the PK, Safety, and Outcomes of Treatment Including High Dose Rifampicin +/- Levofloxacin vs Standard Treatment for Pediatric Tuberculous Meningitis (TBM)

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 03 Oct 2021

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At a glance

  • Drugs Levofloxacin (Primary) ; Rifampicin (Primary) ; Ethambutol; Isoniazid; Pyrazinamide; Steroids
  • Indications Tubercular meningitis
  • Focus Adverse reactions; Pharmacokinetics
  • Acronyms TBM-KIDS

    • Most Recent Events

    • 22 Jan 2021 Status changed from active, no longer recruiting to completed.
    • 12 Nov 2020 Planned End Date changed from 1 Nov 2020 to 1 Jun 2021.
    • 12 Nov 2020 Planned primary completion date changed from 1 Nov 2020 to 1 Jun 2021.

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