Lowering InterLeukin-1 Receptor Antagonist Concentrations After TB Treatment Onset

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-21

Study Completion Date

2021-03-31

Brief Summary

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Despite marked improvements in the diagnosis of tuberculosis there are difficulties in diagnosing and monitoring treatment outcome among TB patients. The use of immunological biomarkers alone or in combination with other clinical parameters could predict early the response to TB treatment. The aim of this study is to demonstrate that the IL-1 receptor antagonist (IL-1Ra) concentrations significantly decrease within two weeks following TB treatment initiation in adults with active documented TB.

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Detailed Description

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The HIV/AIDS epidemic and Tuberculosis (TB) remain important challenges for global public health and are strongly linked. Despite marked improvements in the diagnosis of tuberculosis, there are difficulties in diagnosing and monitoring treatment outcome among TB patients. The use of immunological biomarkers alone or in combination with other clinical parameters could better predict the response to TB treatment. The aim of this study is to demonstrate that the IL-1 receptor antagonist (IL-1Ra) concentrations significantly decrease within two weeks following TB treatment initiation in adults with active documented TB. This is a proof-of-concept study, among 100 patients (50 HIV positive and 50 HIV negative) with documented active TB, in Cambodge and Côte d'Ivoire. Patients recruited for this study will receive the standard TB treatment per their respective national treatment guidelines. Plasma samples will be collected at baseline (initiation of TB treatment), weeks 1, 2, 4 and 8 to measure IL-1Ra, sCD163 and IP-10.

Conditions

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Tuberculosis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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TB HIV-negative

Patients will receive standard TB treatment and will be followed according to the national procedures.

In addition, plasma samples will be collected at baseline, Week 1, Week 2, Week 4 and Week 8 to measure IL-1Ra, sCD163 and IP-10. Baseline will be the initiation of TB treatment.

All participants will be followed 24 weeks.

No interventions assigned to this group

TB HIV-positive

Patients will receive standard TB treatment and will be followed according to the national procedures.

In addition, plasma samples will be collected at baseline, Week 1, Week 2, Week 4 and Week 8 to measure IL-1Ra, sCD163 and IP-10. Baseline will be the initiation of TB treatment.

All participants will be followed 24 weeks.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years
* Evidence of TB, with: positive Xpert MTB/RIF
* For HIV infected patients:

* ART-naïve
* Regardless of CD4 cell counts
* Written informed consent
* Willingness to be followed up in the study clinics for 6 months after inclusion

Exclusion Criteria

* Mycobacterium tuberculosis strain resistant to rifampin with Xpert MTB/RIF
* Ongoing TB treatment
* Overt evidence of other ongoing opportunistic infections
* Pregnant or breastfeeding women
* Karnofsky score ≤ 30
* Person unable to understand the study
* Person currently participating in clinical trial
* Females on oestroprogestative and progestative hormonal contraception

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No