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

December 15, 2019 updated by: Fundació Institut Germans Trias i Pujol

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Georgia
      • Tbilisi, Georgia
        • National Center for Tuberculosis and Lung Diseases
  • South Africa
      • Soweto, South Africa, 1862,
        • Perinatal HIV Unit (PHRU)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
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.
Other Names:
  • anti-TB treatment
Experimental: 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
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.
Other Names:
  • anti-TB treatment
Drug: Ibuprofen
Non-Steroid Anti-Inflammatory drug to be administered as adjunctive therapy
Other Names:
  • NSAID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months
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
6 months: at baseline, at month 3 and month 6
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
6 months
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
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.
2 and 6 months
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.
2 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundació Institut Germans Trias i Pujol

Collaborators

National Center for Tuberculosis and Lung Disease, Tbilisi, Georgia

Investigators

  • Principal Investigator: Cris Vilaplana, MD, PhD, Fundació Institut Germans Trias i Pujol

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

May 2, 2016

First Submitted That Met QC Criteria

May 20, 2016

First Posted (Estimate)

May 25, 2016

Study Record Updates

Last Update Posted (Actual)

December 17, 2019

Last Update Submitted That Met QC Criteria

December 15, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSAIDS4TB_01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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