TuberculosisLILAC-TBNCT04015713
Lowering InterLeukin-1 Receptor Antagonist Concentrations After TB Treatment Onset
An observational study of Tuberculosis, run by ANRS, Emerging Infectious Diseases at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Tuberculosis
- How many people
- 100 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 21 Jan 2020to Mar 2021
- Phase
- Observational
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Cambodia1 site, 1 recruiting
- Not yet recruiting
Institut Pasteur Cambodge
Phnom Penh
Polidy Pean, MD, PhD, polidy@pasteur-kh.org
Laurence Borand, lborand@pasteur-kh.org
Côte d’Ivoire1 site, 1 recruiting
- Recruiting
CEPREF/Programme PACCI
Abidjan
Raoul Moh, MD,PhD, +225 07 82 83 79, raoul.moh@pacci.ci
Alexandra Bitty-Anderson, MPH, +225 01 14 95 38, alexandra.bitty@pacci.ci
About this study
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)
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.
Read the 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.
- Conditions
- Tuberculosis
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 8 weeks
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
Measured: 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
Measured: 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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start21 Jan 2020
- Primary completionMar 2021 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- Institut Pasteur, Cambodia, Institut National de la Santé Et de la Recherche Médicale, France, European Georges Pompidou Hospital
- Responsible party
- Sponsor
- Investigators
- Laurence Weiss, MD,PhD, Principal investigator, APHP Georges Pompidou European Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04015713
- Sponsor's protocol ID
- ANRS 12394 LILAC-TB
- Acronym
- LILAC-TB
- Status last verified
- Feb 2020
- First submitted
- 2 Jul 2019
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04015713
- Acronym / sponsor ID
- LILAC-TB / ANRS 12394 LILAC-TB
- Conditions
- Tuberculosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- Institut Pasteur, Cambodia, Institut National de la Santé Et de la Recherche Médicale, France, European Georges Pompidou Hospital
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 11 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
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
Evolution of the concentration of sCD163 between baseline (initiation of TB treatment) and weeks 1, 2, 4 and 8
Time frame: 8 weeks
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
- Individual participant dataSharing planned: No
Related trials for Tuberculosis
RecruitingPhase 4
Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease
Mycobacterium Avium Complex Pulmonary Disease
RecruitingObservational study
Paradoxical Tuberculosis Reactions in Patients Without HIV Infection
Tuberculosis
Not yet recruitingPhase 2
Re-evaluating the Duration in Children of TB Treatment
Tuberculosis
RecruitingPhase 1/2
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
Tuberculosis
Active, not recruitingPhase 3
Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients
Tuberculosis, MDR
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurence Weiss, MD,PhD principal investigator
APHP Georges Pompidou European Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, run by ANRS, Emerging Infectious Diseases 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 7 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: status not confirmed, as of the sponsor's last update on 6 Feb 2020. 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 Cambodia, Côte d’Ivoire. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laurence Weiss, MD,PhD (33 (1) 56 09 3297, laurence.weiss@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of the plasma concentration of IL-1Ra between baseline (initiation of TB treatment) and Week 2 (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2020.