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

• Status: Completed
• Trial end date: 2019-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundació Institut Germans Trias i Pujol
• Collaborators: National Center for Tuberculosis and Lung Disease, Tbilisi, Georgia; National Center for Tuberculosis and Lung Diseases of Georgia (NCTLD)
• Treatments: Ibuprofen

Criteria

Inclusion Criteria:

1. Females and males aged ≥ 16

2. The patient must provide written informed consent

3. Females of childbearing potential (including females less than 2 years post- menopausal) must have a negative pregnancy test at enrolment and must agree to use highly effective methods of birth control

4. M.tuberculosis (Mtb) detected by culture with available drug susceptibility results for current isolate

5. XDR- TB confirmed by drug susceptibility testing (DST)

Exclusion Criteria:

A potential subject who meets any of the following criteria will be excluded from participation in this study:

1. Inability to provide written informed consent

2. First line drug treatment susceptible Mtb strain

3. Prior Treatment of either >3 days of TB treatment prior to randomization

4. Pregnancy/Breastfeeding at inclusion

5. Any of the following laboratory parameters: Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 x upper limit of normal (ULN); total bilirubin > 2 x ULN; estimated glomerular filtration rate (eGFR) <60ml/hr; Neutrophil count ≤ 500 neutrophils / mm3; Platelet count < 50,000 cells / mm3

6. Receiving or anticipated to receive a daily dose of ≥ 10 mg of systemic prednisone or equivalent within the period starting 14 days prior to enrolment, or > 5 doses per week of any NSAID for ≥2 weeks in the month prior to randomization.

7. History of sensitivity or allergy to ibuprofen.