Diagnostics and Pharmacotherapy for Severe Forms of TB (DMID 15-0100)

Diagnostics and Pharmacotherapy for Severe Forms of TB


Lead Sponsor: University of Virginia

Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
Scientific Center for Family Health and Human Reproduction Problems, Russia
Kilimanjaro Christian Medical Centre, Tanzania
Haydom Lutheran Hospital
Mbarara University of Science and Technology
International Centre for Diarrhoeal Disease Research, Bangladesh
University of Florida

Source University of Virginia
Brief Summary

Major Research Aim: To study novel molecular diagnostics and the pharmacokinetic variability among a spectrum of TB disease states, including severe forms of TB like disseminated TB, TB meningitis and drug resistant TB, among adults and children from multiple international sites.

Detailed Description

Aim 1. Measure pharmacokinetics to anti-tuberculosis (TB) medications in severe TB syndromes (including multidrug-resistant TB, pediatric TB, TB sepsis and TB meningitis) from diverse geographies (including Tanzania, Uganda, Bangladesh, and Siberia) and correlate these findings to TB treatment outcome (TB treatment failure: death/ default/ relapse/ further acquired drug resistance). Aim 2. Decipher mechanisms of pharmacokinetic variability to TB drugs, particularly malabsorption due to concurrent gastrointestinal disease. Aim 3. Deployment of quantitative susceptibility testing (minimum inhibitory concentration-MIC) and rapid MIC-informed molecular methods (e.g., TaqMan Array Card-TAC) for M. tuberculosis. In addition to the stated aims, the primary elements of capacity building requisite for this project include the training in and deployment of the fieldable molecular diagnostic platforms, onsite pharmacokinetic monitoring, and a broad strengthening of longitudinal cohort management for clinical research.

Overall Status Enrolling by invitation
Start Date 2016-04-28
Completion Date 2019-12-01
Primary Completion Date 2019-09-01
Study Type Observational
Primary Outcome
Measure Time Frame
Measure area under the concentration curve (AUC) to anti-tuberculosis (TB) medications relative to TB treatment outcome in severe TB syndromes December 2019
Secondary Outcome
Measure Time Frame
Collect stool in patients undergoing pharmacokinetic testing to measure the environmental enteropathy index December 2019
Collect stool in patients undergoing pharmacokinetic testing to measure the quantitative burden and species distribution of enteric pathogens by the enteric TAC assay- 35 bacterial, viral, parasitic species) December 2019
Enrollment 713

Sampling Method:

Non-Probability Sample


Inclusion Criteria: Patients admitted to one of the study site hospitals with at least ONE of the following: 1. Clinical suspicion for TB in a child, as defined by NIH Consensus Case Definitions for TB research in children, and started on TB treatment 2. Clinical suspicion for TB meningitis, as defined by the International TB Meningitis Workshop Consensus Case Definitions for TB Meningitis 3. Clinical suspicion for TB sepsis, as defined by the Uganda/PRISM-U definitions 4. Microbiologic evidence of MDR-TB from a respiratory specimen within the past 6 months Exclusion Criteria: 1. Pregnant women-self reported 2. Patient unable per treating physician discretion to undergo sample collection 3. Patient or representative/guardian unable to sign written informed consent 4. Patient unable to return for follow-up or be contacted by phone for follow-up



Minimum Age:


Maximum Age:


Healthy Volunteers:


Overall Official
Last Name Role Affiliation
Scott K Heysell, MD Principal Investigator University of Virginia
Verification Date


Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Virginia

Investigator Full Name: Scott Heysell, MD

Investigator Title: Associate Professor of Medicine, Division of Infectious Diseases and International Health

Has Expanded Access No
Condition Browse
Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

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