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Optimizing Treatment to Improve TBM Outcomes in Children

NCT02958709 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2021-10-28

No results posted yet for this study

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.

Conditions

  • Tuberculosis, Meningeal

Interventions

DRUG

High-dose: RIF, INH, PZA, EMB

high-dose rifampicin plus standard dose H,Z,E, given for 8 weeks in treatment Arms 1 and 2

DRUG

High dose: RIF, INH, PZA, LEVO

high-dose rifampicin plus standard dose H,Z, with levofloxacin substituted for ethambutol for 8 weeks in treatment Arm 2

DRUG

Standard of care: RIF, INH, PZA, EMB

standard doses of R,H,Z,E given for 8 weeks in treatment Arm 3, control arm.

Sponsors & Collaborators

  • National Institute for Research in Tuberculosis, Chennai, India

    collaborator UNKNOWN

  • University of North Carolina

    collaborator OTHER

  • B. J. Medical College, Pune

    collaborator OTHER

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Kelly Dooley, MD,PhD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-22
Primary Completion
2020-11-15
Completion
2020-11-15

Countries

  • India
  • Malawi

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02958709 on ClinicalTrials.gov