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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

478 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-28

Study Completion Date

2021-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

DIAgnostics for Multidrug Resistant Tuberculosis in Africa

NCT03303963

Tuberculosis, Multidrug-Resistant

COMPLETED

Tuberculosis in China

NCT01071603

Tuberculosis Tuberculosis, Multidrug-Resistant Extensively Drug Resistant Tuberculosis

COMPLETED

Rapid Research in Diagnostics Development for TB Network

NCT04923958

Tuberculosis

RECRUITING NA

Biomarkers for Therapy Response in Drug-resistant Tuberculosis

NCT02597621

Tuberculosis, Multidrug-resistant

COMPLETED

Biodistribution and Pharmacokinetics of Pretomanid in Tuberculosis Patients Using 18F-Pretomanid PET

NCT05609552

Tuberculosis

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tuberculosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No