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NCT Number: NCT02781909

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

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.

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Center for Tuberculosis and Lung Diseases, Tbilisi, Georgia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Females and males aged ≥ 16
  • The patient must provide written informed consent
  • 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
  • M.tuberculosis (Mtb) detected by culture with available drug susceptibility results for current isolate
  • 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:

  • Inability to provide written informed consent
  • First line drug treatment susceptible Mtb strain
  • Prior Treatment of either >3 days of TB treatment prior to randomization
  • Pregnancy/Breastfeeding at inclusion
  • 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
  • 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.
  • History of sensitivity or allergy to ibuprofen.

Treatment and study plan

Ibuprofen

Drug

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

Other names: NSAID

Standard of Care TB treatment

Drug

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 names: anti-TB treatment

Primary outcomes

  1. Number of pilot study participants with microbiological efficacy-related events that are related to treatment.

    Time frame: 6 months

    Number of pilot study participants with negative sputum culture at M2 and M6 following inclusion

  2. Number of pilot study participants with radiological efficacy-related events that are related to treatment.

    Time frame: 6 months: at baseline, at month 3 and month 6

    Changes detected by X-ray during follow-up up to month 6

  3. Number of pilot study participants with clinical efficacy-related events that are related to treatment.

    Time frame: 6 months

    Final treatment outcomes according to the WHO definitions including all time in follow-up to M6 on TB treatment

  4. Microbiological efficacy-related events: Time to stable culture conversion up to M6

    Time frame: 6 months

    Time to stable culture conversion up to M6: (≥ two consecutive cultures negative for M. tuberculosis) including all time in follow-up to month six on TB treatment. Differences between the two groups

Secondary outcomes

  1. Number of pilot study participants with Safety-related events.

    Time frame: 6 months

    Outcome measurements: incidence of safety-related events during the whole study period: clinical worsening of the disease, no sputum conversion (if AFS-), any worsening concerning vital parameters and routine blood work.

  2. Proportion of pilot study participants showing differences in Health Quality of Life (HQoL).

    Time frame: 2 and 6 months

    Outcome measurements: HQoL measures at M2 and M6 relative to baseline.

  3. Proportion of pilot study participants showing differences in Immune Responses at M2 and M6 relative to baseline.

    Time frame: 2 and 6 months

    Outcome measurements: changes detected in immune responses at M2 and M6.

Sponsors and collaborators

Lead sponsor

Fundació Institut Germans Trias i Pujol

Other

Collaborators

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

Registry information

Official study title

Pilot Study to Estimate the Potential Efficacy and Safety of Using Adjunctive Ibuprofen for the Treatment of XDR Tuberculosis

Acronym: NSAIDS-XDRTB

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
May 25, 2016
Registry last updated
Dec 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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