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Potential Efficacy and Safety of Using Adjunctive Ibuprofen for XDR-TB Tuberculosis

NCT02781909 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-12-17

No results posted yet for this study

Summary

Novel approaches to improve TB treatment outcomes (to reduce morbidity, mortality, and the duration of TB treatment) and to treat XDR-TB cases are urgently required. Host-Directed therapies (especially repurposed drugs such as Non-Steroid AntiInflammatory Drugs NSAIDS) could be useful in this context, and therefore the appropriateness and potential effect of this approach needs to be evaluated in humans. Investigators do propose a prospective, randomized, pilot study to estimate the potential efficacy and safety of using adjunctive ibuprofen for the treatment of XDR tuberculosis.

Conditions

Interventions

DRUG

Ibuprofen

Non-Steroid Anti-Inflammatory drug to be administered as adjunctive therapy

DRUG

Standard of Care TB treatment

Standard of Care (SoC) TB Treatment will be optimized and drugs selected according to the National and WHO Guidelines, sensitivity profile and as per routine.

Sponsors & Collaborators

  • National Center for Tuberculosis and Lung Disease, Tbilisi, Georgia

    collaborator OTHER

  • Fundació Institut Germans Trias i Pujol

    lead OTHER

Principal Investigators

  • Cris Vilaplana, MD, PhD · Fundació Institut Germans Trias i Pujol

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2019-01-31
Completion
2019-01-31

Countries

  • Georgia
  • South Africa

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT02781909 on ClinicalTrials.gov