Potential Efficacy and Safety of Using Adjunctive Ibuprofen for XDR-TB Tuberculosis (NSAIDS-XDRTB)

Fundació Institut Germans Trias i Pujol

Status and phase: Completed; Phase 2

Conditions: Tuberculosis

Treatments: Drug: Standard of Care TB treatment; Drug: Ibuprofen

Study type: Interventional

Funder types: Other

Identifiers

NCT02781909

NSAIDS4TB_01

Details and patient eligibility

About

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.

Full description

There are a need for novel approaches to improve TB treatment outcomes (to reduce morbidity, mortality, and the duration of TB treatment) and to treat XDR-TB cases. 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 clinical trial to evaluate the potential efficacy and safety of using adjunctive ibuprofen during two months for the treatment of XDR tuberculosis.

Enrollment: 24 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Control: Standard of Care TB treatment

Active Comparator group

Description:

Individuals with confirmed pulmonary XDR-TB and receiving Standard of Care TB treatment according to national and WHO guidelines; n=12

Treatment:

Drug: Standard of Care TB treatment

Ibuprofen-treated

Experimental group

Description:

Individuals with confirmed pulmonary XDR-TB and receiving Standard of Care TB treatment according to national and WHO guidelines plus ibuprofen (400mg/day/2 months); n=12

Treatment:

Drug: Ibuprofen

Drug: Standard of Care TB treatment