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TuberculosisPhase 2NSAIDS-XDRTBNCT02781909

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

A Phase 2 study testing Ibuprofen in people with Tuberculosis, run by Fundació Institut Germans Trias i Pujol at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Tuberculosis
What is being tested?
Ibuprofen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
2 sitesin 2 countries
Study dates
Sep 2016to Jan 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Georgia1 site

  • National Center for Tuberculosis and Lung Diseases

    Tbilisi

Other trials in Georgia

South Africa1 site

  • Perinatal HIV Unit (PHRU)

    Soweto, 1862,

Other trials in South Africa

About this study

Official title: 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.

Read the 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.

Conditions
Tuberculosis
Being tested
Ibuprofen, Standard of Care TB treatment
Keywords
NSAIDS, tuberculosis treatment, anti-inflammatories, Host-directed therapies, TB
Medical subject headings
Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IbuprofenDrug

    Also called NSAID

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

  • Standard of Care TB treatmentDrug

    Also called anti-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.

Study groups in NCT02781909
Study groupRoleWhat they receive
Control: Standard of Care TB treatmentActive comparatorIndividuals with confirmed pulmonary XDR-TB and receiving Standard of Care TB treatment according to national and WHO guidelines; n=12
Receives: Drug: Standard of Care TB treatment
Ibuprofen-treatedExperimentalIndividuals 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
Receives: Drug: Ibuprofen; Drug: Standard of Care TB treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 6 months

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

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

    Measured: 6 months: at baseline, at month 3 and month 6

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

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

    Measured: 6 months

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

    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

    Measured: 6 months

Secondary outcomes (3)

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

    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.

    Measured: 6 months

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

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

    Measured: 2 and 6 months

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

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

    Measured: 2 and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2016 (estimated)
  2. Study startSep 2016
  3. Primary completionJan 2019
  4. Study completionJan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02781909
Sponsor's protocol ID
NSAIDS4TB_01
Acronym
NSAIDS-XDRTB
Status last verified
Dec 2019
First submitted
2 May 2016
Last updated
17 Dec 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Fonseca KL, Farres J, Barbakadze K, Jikia I, Tsotskhalashvili M, Garcia-Illarramendi JM, Arias L, Otwombe K, Sopegno C, Despuig A, Martinson N, Buhiichyk N, Korinteli T, Layre E, Nigou J, Avaliani Z, Tukvadze N, Vashakidze S, Vilaplana C. Adjunctive ibuprofen in pre-extensively drug-resistant and extensively drug-resistant tuberculosis: a phase IIA open-label pilot clinical trial. Nat Commun. 2026 Jul 1. doi: 10.1038/s41467-026-75148-9. Online ahead of print.

    PubMed 42386760

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ibuprofen in people with Tuberculosis, run by Fundació Institut Germans Trias i Pujol at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Georgia, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of pilot study participants with microbiological efficacy-related events that are related to treatment. (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02781909, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.

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