Potential Efficacy and Safety of Using Adjunctive Ibuprofen for XDR-TB Tuberculosis
NCT ID: NCT02781909
Last Updated: 2019-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
24 participants
INTERVENTIONAL
2016-09-30
2019-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control: Standard of Care TB treatment
Individuals with confirmed pulmonary XDR-TB and receiving Standard of Care TB treatment according to national and WHO guidelines; n=12
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.
Ibuprofen-treated
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
Ibuprofen
Non-Steroid Anti-Inflammatory drug to be administered as adjunctive therapy
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.
Interventions
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Ibuprofen
Non-Steroid Anti-Inflammatory drug to be administered as adjunctive therapy
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
16 Years
ALL
No
Sponsors
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National Center for Tuberculosis and Lung Disease, Tbilisi, Georgia
OTHER
Fundació Institut Germans Trias i Pujol
OTHER
Responsible Party
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Principal Investigators
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Cris Vilaplana, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Fundació Institut Germans Trias i Pujol
Locations
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National Center for Tuberculosis and Lung Diseases
Tbilisi, , Georgia
Perinatal HIV Unit (PHRU)
Soweto, , South Africa
Countries
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Related Links
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Experimental Tuberculosis Unit of the Germans Trias i Pujol website (PI's affiliation)
Host-Directed Therapies Network website
Other Identifiers
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NSAIDS4TB_01
Identifier Type: -
Identifier Source: org_study_id