NCT04015713

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 11, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

January 21, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

February 6, 2020

Status Verified

February 1, 2020

Enrollment Period

1.1 years

First QC Date

July 2, 2019

Last Update Submit

February 5, 2020

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (1)

  • Evolution of the plasma concentration of IL-1Ra between baseline (initiation of TB treatment) and Week 2

    To measure plasma concentrations of IL - 1Ra among TB patients after two weeks of TB treatment

    2 weeks

Secondary Outcomes (4)

  • Evolution of the plasma concentration of IL-1Ra between baseline (initation of TB treatment) and weeks 1, 2, 4 and 8

    8 weeks

  • Evolution of the concentration of sCD163 between baseline (initiation of TB treatment) and weeks 1, 2, 4 and 8

    8 weeks

  • Evolution of the plasma concentration of IP-10 between baseline (initiation of TB treatment) and weeks 1, 2, 4 and 8

    8 weeks

  • Impact of the occurrence of events on the evolution of biomarkers from baseline (initiation of TB treatment) to the end of treatment (Week 24)

    24 weeks

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institut Pasteur Cambodge

Phnom Penh, Cambodia

NOT YET RECRUITING

CEPREF/Programme PACCI

Abidjan, Côte d’Ivoire

RECRUITING

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)

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Laurence Weiss, MD,PhD

    APHP Georges Pompidou European Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurence Weiss, MD,PhD

CONTACT

33 (1) 56 09 3297laurence.weiss@aphp.fr

Polidy Pean, MD,PhD

CONTACT

855 (0) 125 521 82polidy@pasteur-kh.org

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2019

First Posted

July 11, 2019

Study Start

January 21, 2020

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

February 6, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)CÔ(1)