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| Name | Class |
|---|---|
| Institut Pasteur, Cambodia | OTHER |
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
| European Georges Pompidou Hospital | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of the plasma concentration of IL-1Ra between baseline (initation of TB treatment) and weeks 1, 2, 4 and 8 | 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 | 8 weeks |
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Inclusion Criteria:
Age ≥ 18 years
Evidence of TB, with: positive Xpert MTB/RIF
For HIV infected patients:
Written informed consent
Willingness to be followed up in the study clinics for 6 months after inclusion
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laurence Weiss, MD,PhD | Contact | 33 (1) 56 09 3297 | laurence.weiss@aphp.fr | |
| Polidy Pean, MD,PhD | Contact | 855 (0) 125 521 82 | polidy@pasteur-kh.org |
| Name | Affiliation | Role |
|---|---|---|
| Laurence Weiss, MD,PhD | APHP Georges Pompidou European Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Pasteur Cambodge | Not yet recruiting | Phnom Penh | Cambodia |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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Blood samples drawn at inclusion, week 1, week 2, week 4 and week 8 and biobank (DBS, plasma and dry blood pellet)
| Evolution of the concentration of sCD163 between baseline (initiation of TB treatment) and weeks 1, 2, 4 and 8 |
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 |
| 8 weeks |
| Evolution of the plasma concentration of IP-10 between baseline (initiation of TB treatment) and weeks 1, 2, 4 and 8 | 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 | 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) | 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. | 24 weeks |
| CEPREF/Programme PACCI | Recruiting | Abidjan | Côte d’Ivoire |
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| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |