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Lowering InterLeukin-1 Receptor Antagonist Concentrations After TB Treatment Onset (LILAC-TB)

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ClinicalTrials.gov Identifier: NCT04015713
Recruitment Status : Not yet recruiting
First Posted : July 11, 2019
Last Update Posted : July 11, 2019
Sponsor:
Collaborators:
Institut Pasteur, Cambodia
Institut National de la Santé Et de la Recherche Médicale, France
European Georges Pompidou Hospital
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Brief Summary:
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.

Condition or disease
Tuberculosis

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: LILAC - TB : Lowering InterLeukin-1 Receptor Antagonist Concentrations After TB Treatment Onset : a Proof of Concept Study in Cambodia and Ivory Coast (ANRS 12394)
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Group/Cohort
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.

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.




Primary Outcome Measures :
  1. Evolution of the plasma concentration of IL-1Ra between baseline (initiation of TB treatment) and Week 2 [ Time Frame: 2 weeks ]
    To measure plasma concentrations of IL - 1Ra among TB patients after two weeks of TB treatment


Secondary Outcome Measures :
  1. Evolution of the plasma concentration of IL-1Ra between baseline (initation of TB treatment) and weeks 1, 2, 4 and 8 [ Time Frame: 8 weeks ]
    To measure plasma concentrations of IL - 1Ra and assess the evolution of the concentration of IL-1Ra among TB patients at week 1, week 2, week 4 and week 8 after treatment initiation

  2. Evolution of the concentration of sCD163 between baseline (initiation of TB treatment) and weeks 1, 2, 4 and 8 [ Time Frame: 8 weeks ]
    To measure plasma concentrations of sCD163 and assess the evolution of the concentration of IL-1Ra among TB patients at week 1, week 2, week 4 and week 8 after treatment initiation

  3. Evolution of the plasma concentration of IP-10 between baseline (initiation of TB treatment) and weeks 1, 2, 4 and 8 [ Time Frame: 8 weeks ]
    To measure plasma concentrations of IP-10 and assess the evolution of the concentration of IL-1Ra among TB patients at week 1, week 2, week 4 and week 8 after treatment initiation

  4. Impact of the occurrence of events on the evolution of biomarkers from baseline (initiation of TB treatment) to the end of treatment (Week 24) [ Time Frame: 24 weeks ]
    Impact of the occurrence of the following events/situations on the evolution of biomarkers (IL-1Ra,sCD163 and IP-10) : intercurrent infection, TB-associated immune reconstitution inflammatory syndrome (IRIS), TB treatment outcome, MTb strains resistant to TB drugs.


Biospecimen Retention:   Samples Without DNA
Blood samples drawn at inclusion, week 1, week 2, week 4 and week 8 and biobank (DBS, plasma and dry blood pellet)


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  • 100 patients with documented active TB, 50 in Cambodia and 50 in Côte d'Ivoire
  • 60 patients HIV-infected and 40 patients HIV negative
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04015713


Contacts
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Contact: Laurence Weiss, MD,PhD 33 (1) 56 09 3297 laurence.weiss@aphp.fr
Contact: Polidy Pean, MD,PhD 855 (0) 125 521 82 polidy@pasteur-kh.org

Locations
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Cambodia
Institut Pasteur Cambodge Not yet recruiting
Phon Phen, Cambodia
Contact: Polidy Pean, MD, PhD       polidy@pasteur-kh.org   
Contact: Laurence Borand       lborand@pasteur-kh.org   
Côte D'Ivoire
CEPREF/Programme PACCI Not yet recruiting
Abidjan, Côte D'Ivoire
Contact: Raoul Moh, MD,PhD    +225 07 82 83 79    raoul.moh@pacci.ci   
Contact: Alexandra Bitty-Anderson, MPH    +225 01 14 95 38    alexandra.bitty@pacci.ci   
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Institut Pasteur, Cambodia
Institut National de la Santé Et de la Recherche Médicale, France
European Georges Pompidou Hospital
Investigators
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Principal Investigator: Laurence Weiss, MD,PhD APHP Georges Pompidou European Hospital

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Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier: NCT04015713     History of Changes
Other Study ID Numbers: ANRS 12394 LILAC-TB
First Posted: July 11, 2019    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Interleukin 1 Receptor Antagonist Protein
Antirheumatic Agents