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Intensified Tuberculosis Treatment to Reduce the Mortality of Patients With Tuberculous Meningitis (INTENSE-TBM)

Primary Purpose

Tuberculous Meningitis

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Aspirin
Placebo of aspirin
WHO TBM treatment
Intensified TBM treatment
Sponsored by
ANRS, Emerging Infectious Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tuberculous Meningitis focused on measuring Tuberculous Meningitis, Intensified treatment, High dose Rifampicin, Linezolid, Aspirin, Subsaharan Africa

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  1. Age ≥ 15 years
  2. TBM defined as "definite", "probable" or "possible"

  3. Signed Informed Consent

    • Definite TBM = at least one of the following criteria: acid-fast bacilli seen in CSF microscopy, positive CSF M. tuberculosis culture, or positive CSF M. tuberculosis commercial nucleic acid amplification test.
    • Probable TBM = total modified Marais score ≥12 when neuroimaging is available, or ≥10 when neuroimaging is not available (at least 2 points should come from CSF or cerebral imaging criteria).
    • Possible TBM = total modified Marais 6-11 when neuroimaging is available, or 6-9 when neuroimaging is not available.

Exclusion criteria:

  • > 5 days of TB treatment
  • Renal failure (eGFR<30 ml/min, CKD-EPI formula).
  • Neutrophil count < 0.6 x 109/L.
  • Hemoglobin concentration < 8 g/dL.
  • Total bilirubin > 2.6 times the Upper Limit of Normal
  • Platelet count < 50 x 109/L.
  • ALT > 5 times the Upper Limit of Normal.
  • Clinical evidence of liver failure or decompensated cirrhosis.
  • For women: more than 17 weeks pregnancy or breastfeeding.
  • For patients without decrease level of consciousness (Glasgow Coma Scale = 15): Peripheral neuropathy scoring Grade 3 or above on the Brief Peripheral Neuropathy Score (BPNS).
  • Documented M. tuberculosis resistance to rifampicin.
  • Positive gram-stain, bacterial culture or cryptococcal antigen in the Cerebral Spinal Fluid.
  • Evidence of active bleeding (hemoptysis, gastrointestinal bleeding, hematuria, intracranial bleeding).
  • Inability to collect Cerebral Spinal Fluid, except for patients with confirmed tuberculosis (by rapid molecular test or culture) from another biological sample and clinical and/or CT scan evidence of meningitis.
  • Major surgery within the last two weeks prior to inclusion.
  • Ongoing chronic aspirin treatment (eg for cardiovascular risk).
  • Current use of drugs contraindicated with study drugs and that cannot be safely stopped (see Appendix 1: Drugs contra-indicated with study drugs).

  • In available history from patients:

    • Evidence of past intracranial bleeding.
    • Evidence of past of peptic ulceration.
    • Evidence of recent (< 3 month) gastrointestinal bleeding.
    • Known hypersensitivity contraindicating the use of study drugs .
    • Evidence of porphyria.
    • Evidence of hyperuricemia or gout.
  • Any reason which at the discretion of the investigator would compromise safety and cooperation in the trial.

Sites / Locations

  • Cocody University Hospital
  • Treichville University HospitalRecruiting
  • Yopougon University Hospital
  • University Hospital Joseph Raseta BefelatananaRecruiting
  • University Hospital TambohobeRecruiting
  • Morafeno University Hospital
  • Kayelitsha District HospitalRecruiting
  • Mitchells Plain HospitalRecruiting
  • New Somerset HospitalRecruiting
  • Dora Nginza HospitalRecruiting
  • Livingstone and PE Central HospitalsRecruiting
  • Mbarara Regional Reference HospitalRecruiting
  • Regional Reference Hospital of KabaleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

WHO TBM treatment + placebo

WHO TBM treatment + aspirin

Intensified TBM treatment + placebo

Intensified TBM treatment + aspirin

Arm Description

Inclusion (D-0) to end of Week-8 (W-8): isoniazid 5 mg/kg/d + rifampicin 10 mg/kg/d + ethambutol 20 mg/kg/d + pyrazinamide 30 mg/kg/d + placebo of aspirin W-9 to W-40: isoniazid 5 mg/kg/d + rifampicin 10 mg/kg/d.

Inclusion (D-0) to end of Week-8 (W-8): isoniazid 5 mg/kg/d + rifampicin 10 mg/kg/d + ethambutol 20 mg/kg/d + pyrazinamide 30 mg/kg/d + aspirin 200 mg/d W-9 to W-40: isoniazid 5 mg/kg/d + rifampicin 10 mg/kg/d.

Inclusion (D-0) to end of Week-8 (W-8): high dose rifampicin (35 mg/kg/d) + high dose linezolid (1200 mg/d from D-0 to end of W-4, then 600 mg/d from W-5 to W-8) + isoniazid 5 mg/kg/d + ethambutol 20 mg/kg/d + pyrazinamide 30 mg/kg/d + placebo of aspirin W-9 to W-40: isoniazid 5 mg/kg/d + rifampicin 10 mg/kg/d.

Inclusion (D-0) to end of Week-8 (W-8): high dose rifampicin (35 mg/kg/d) + high dose linezolid (1200 mg/d from D-0 to end of W-4, then 600 mg/d from W-5 to W-8) + isoniazid 5 mg/kg/d + ethambutol 20 mg/kg/d + pyrazinamide 30 mg/kg/d + aspirin 200 mg/d W-9 to W-40: isoniazid 5 mg/kg/d + rifampicin 10 mg/kg/d.

Outcomes

Primary Outcome Measures

Rate of all-cause death

Secondary Outcome Measures

Rate of all-cause death
Rate of all-cause death or loss to follow-up
Rate of new central neurological event or aggravation of a central neurological event existing at baseline
Rate of grade 3-4 adverse events (DAIDS adverse events grading table)
Rate of serious adverse events
Rate of solicited treatment related adverse events
Percentage of patients with disability
M. tuberculosis culture conversion rate
Time to culture positivity
Time to first hospital discharge
Cost-effectiveness incremental ratio of trial interventions
Prevalence of resistance to anti-TB drugs among patients with positive culture at inclusion
Subset of patients: In vitro bactericidal activity of anti-TBM treatment
Subset of patients: Maximum Plasma Concentration [Cmax] of rifampicin and linezolid
Plasma Cmax, cerebrospinal fluid [CSF] Cmax, and plasma/CSF Cmax ratio
Subset of patients: Minimum Plasma Concentration [Cmin] of rifampicin and linezolid
Plasma Cmin, cerebrospinal fluid [CSF] Cmin, and plasma/CSF Cmin ratio
Subset of patients: Area Under the Curve [AUC] of rifampicin and linezolid
Plasma AUC, cerebrospinal fluid [CSF] AUC, and plasma/CSF AUC ratio
Subset of patients: Time for maximal concentration [Tmax] of rifampicin and linezolid
Plasma Tmax, cerebrospinal fluid [CSF] Tmax, and plasma/CSF Tmax ratio
Subset of patients: Half-life (t1/2) of rifampicin and linezolid
Plasma t1/2, cerebrospinal fluid [CSF] t1/2, and plasma/CSF t1/2 ratio
HIV-infected participants: Rate of new AIDS-defining illnesses
HIV-infected participants: Percentage of participants with virological success (plasma HIV-1 RNA <50 copies/ml)
HIV-infected participants: CD4 count change from baseline
HIV-infected participants, subset of patients: Maximum Plasma Concentration [Cmax] of of dolutegravir
Plasma Cmax, cerebrospinal fluid [CSF] Cmax, and plasma/CSF Cmax ratio
HIV-infected participants, subset of patients: Minimum Plasma Concentration [Cmin] of dolutegravir
Plasma Cmin, cerebrospinal fluid [CSF] Cmin, and plasma/CSF Cmin ratio
HIV-infected participants, subset of patients: Area Under the Curve [AUC] of dolutegravir
Plasma AUC, cerebrospinal fluid [CSF] AUC, and plasma /CSF AUC ratio
HIV-infected participants, subset of patients: Time for maximal concentration [Tmax] of dolutegravir
Plasma Tmax, cerebrospinal fluid [CSF] Tmax, and plasma /CSF Tmax ratio
HIV-infected participants, subset of patients: Half-life (t1/2) of dolutegravir
Plasma t1/2, cerebrospinal fluid [CSF] t1/2, and plasma/CSF t1/2 ratio

Full Information

First Posted
October 22, 2019
Last Updated
August 1, 2023
Sponsor
ANRS, Emerging Infectious Diseases
Collaborators
European Union, European and Developing Countries Clinical Trials Partnership (EDCTP)
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1. Study Identification

Unique Protocol Identification Number
NCT04145258
Brief Title
Intensified Tuberculosis Treatment to Reduce the Mortality of Patients With Tuberculous Meningitis
Acronym
INTENSE-TBM
Official Title
Intensified Tuberculosis Treatment to Reduce the Mortality of HIV-infected and Uninfected Patients With Tuberculosis Meningitis: a Phase III Randomized Controlled Trial (Acronym: INTENSE-TBM)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 7, 2021 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ANRS, Emerging Infectious Diseases
Collaborators
European Union, European and Developing Countries Clinical Trials Partnership (EDCTP)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
INTENSE-TBM is randomized controlled, phase III, multicenter, 2 x 2 factorial plan superiority trial assessing the efficacity of two interventions to reduce mortality from tuberculous meningitis (TBM) in adolescents and adults with or without HIV-infection in sub-Saharan Africa: Intensified TBM treatment with high-dose rifampicin and linezolid, compared to WHO standard TBM treatment. Aspirin, compared to not receiving aspirin. The trial will be open-label for anti-TB treatment and placebo-controlled for aspirin treatment.
Detailed Description
Settings: Côte d'Ivoire, Madagascar, Uganda, South Africa. Follow-up: Participants will be followed up for 40 weeks. Sample size: 768 patients (192 in each arm). Primary analysis: We will use a Cox proportional hazard ratio model to compare intensified TB treatment with WHO standard TB treatment, and aspirin with placebo, adjusting for the initial stratification variables (trial country, HIV status, British Medical Research Council |BMRC] severity grade). The primary analysis will be conducted in the intention to treat population. Sub-studies: The PK-PD sub-study will take place in the 4 participating countries, and involve 40 participants in total. The Multi-Omics sub-study will only take place in South-Africa. It will involve 160 participants in this country. Participants in each sub-study will sign a specific informed consent.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculous Meningitis
Keywords
Tuberculous Meningitis, Intensified treatment, High dose Rifampicin, Linezolid, Aspirin, Subsaharan Africa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The trial will be open-label for anti-TB treatment and placebo-controlled for aspirin treatment
Allocation
Randomized
Enrollment
768 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
WHO TBM treatment + placebo
Arm Type
Other
Arm Description
Inclusion (D-0) to end of Week-8 (W-8): isoniazid 5 mg/kg/d + rifampicin 10 mg/kg/d + ethambutol 20 mg/kg/d + pyrazinamide 30 mg/kg/d + placebo of aspirin W-9 to W-40: isoniazid 5 mg/kg/d + rifampicin 10 mg/kg/d.
Arm Title
WHO TBM treatment + aspirin
Arm Type
Other
Arm Description
Inclusion (D-0) to end of Week-8 (W-8): isoniazid 5 mg/kg/d + rifampicin 10 mg/kg/d + ethambutol 20 mg/kg/d + pyrazinamide 30 mg/kg/d + aspirin 200 mg/d W-9 to W-40: isoniazid 5 mg/kg/d + rifampicin 10 mg/kg/d.
Arm Title
Intensified TBM treatment + placebo
Arm Type
Other
Arm Description
Inclusion (D-0) to end of Week-8 (W-8): high dose rifampicin (35 mg/kg/d) + high dose linezolid (1200 mg/d from D-0 to end of W-4, then 600 mg/d from W-5 to W-8) + isoniazid 5 mg/kg/d + ethambutol 20 mg/kg/d + pyrazinamide 30 mg/kg/d + placebo of aspirin W-9 to W-40: isoniazid 5 mg/kg/d + rifampicin 10 mg/kg/d.
Arm Title
Intensified TBM treatment + aspirin
Arm Type
Other
Arm Description
Inclusion (D-0) to end of Week-8 (W-8): high dose rifampicin (35 mg/kg/d) + high dose linezolid (1200 mg/d from D-0 to end of W-4, then 600 mg/d from W-5 to W-8) + isoniazid 5 mg/kg/d + ethambutol 20 mg/kg/d + pyrazinamide 30 mg/kg/d + aspirin 200 mg/d W-9 to W-40: isoniazid 5 mg/kg/d + rifampicin 10 mg/kg/d.
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
Two tablets of aspirin 100 mg per day from inclusion (D-0) to end of Week-8 (W-8)
Intervention Type
Drug
Intervention Name(s)
Placebo of aspirin
Intervention Description
Two placebo tablets with the same appearance of aspirin 100 mg per day from inclusion (D-0) to end of Week-8 (W-8)
Intervention Type
Drug
Intervention Name(s)
WHO TBM treatment
Other Intervention Name(s)
Standard WHO treatment for TB meningitis
Intervention Description
2 months of (R-H-Z-E) + 7 months of (R-H)
Intervention Type
Drug
Intervention Name(s)
Intensified TBM treatment
Intervention Description
2 months of (HDR-L-H-Z-E) + 7 months of (R-H), with HDR=high-dose rifampicin and L=linezolid
Primary Outcome Measure Information:
Title
Rate of all-cause death
Time Frame
Up to 40 weeks
Secondary Outcome Measure Information:
Title
Rate of all-cause death
Time Frame
Up to 8 weeks
Title
Rate of all-cause death or loss to follow-up
Time Frame
Up to 40 weeks
Title
Rate of new central neurological event or aggravation of a central neurological event existing at baseline
Time Frame
Up to 40 weeks
Title
Rate of grade 3-4 adverse events (DAIDS adverse events grading table)
Time Frame
Up to 40 weeks
Title
Rate of serious adverse events
Time Frame
Up to 40 weeks
Title
Rate of solicited treatment related adverse events
Time Frame
Up to 40 weeks
Title
Percentage of patients with disability
Time Frame
40 weeks
Title
M. tuberculosis culture conversion rate
Time Frame
1 week and 4 weeks
Title
Time to culture positivity
Time Frame
Up to 40 weeks
Title
Time to first hospital discharge
Time Frame
Up to 40 weeks
Title
Cost-effectiveness incremental ratio of trial interventions
Time Frame
Up to 40 weeks
Title
Prevalence of resistance to anti-TB drugs among patients with positive culture at inclusion
Time Frame
Up to 40 weeks
Title
Subset of patients: In vitro bactericidal activity of anti-TBM treatment
Time Frame
1 week and 4 weeks
Title
Subset of patients: Maximum Plasma Concentration [Cmax] of rifampicin and linezolid
Description
Plasma Cmax, cerebrospinal fluid [CSF] Cmax, and plasma/CSF Cmax ratio
Time Frame
1 week and 4 weeks
Title
Subset of patients: Minimum Plasma Concentration [Cmin] of rifampicin and linezolid
Description
Plasma Cmin, cerebrospinal fluid [CSF] Cmin, and plasma/CSF Cmin ratio
Time Frame
1 week and 4 weeks
Title
Subset of patients: Area Under the Curve [AUC] of rifampicin and linezolid
Description
Plasma AUC, cerebrospinal fluid [CSF] AUC, and plasma/CSF AUC ratio
Time Frame
1 week and 4 weeks
Title
Subset of patients: Time for maximal concentration [Tmax] of rifampicin and linezolid
Description
Plasma Tmax, cerebrospinal fluid [CSF] Tmax, and plasma/CSF Tmax ratio
Time Frame
1 week and 4 weeks
Title
Subset of patients: Half-life (t1/2) of rifampicin and linezolid
Description
Plasma t1/2, cerebrospinal fluid [CSF] t1/2, and plasma/CSF t1/2 ratio
Time Frame
1 week and 4 weeks
Title
HIV-infected participants: Rate of new AIDS-defining illnesses
Time Frame
Up to 40 weeks
Title
HIV-infected participants: Percentage of participants with virological success (plasma HIV-1 RNA <50 copies/ml)
Time Frame
28 weeks and 40 weeks
Title
HIV-infected participants: CD4 count change from baseline
Time Frame
28 weeks and 40 weeks
Title
HIV-infected participants, subset of patients: Maximum Plasma Concentration [Cmax] of of dolutegravir
Description
Plasma Cmax, cerebrospinal fluid [CSF] Cmax, and plasma/CSF Cmax ratio
Time Frame
1 week and 4 weeks
Title
HIV-infected participants, subset of patients: Minimum Plasma Concentration [Cmin] of dolutegravir
Description
Plasma Cmin, cerebrospinal fluid [CSF] Cmin, and plasma/CSF Cmin ratio
Time Frame
1 week and 4 weeks
Title
HIV-infected participants, subset of patients: Area Under the Curve [AUC] of dolutegravir
Description
Plasma AUC, cerebrospinal fluid [CSF] AUC, and plasma /CSF AUC ratio
Time Frame
1 week and 4 weeks
Title
HIV-infected participants, subset of patients: Time for maximal concentration [Tmax] of dolutegravir
Description
Plasma Tmax, cerebrospinal fluid [CSF] Tmax, and plasma /CSF Tmax ratio
Time Frame
1 week and 4 weeks
Title
HIV-infected participants, subset of patients: Half-life (t1/2) of dolutegravir
Description
Plasma t1/2, cerebrospinal fluid [CSF] t1/2, and plasma/CSF t1/2 ratio
Time Frame
1 week and 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Age ≥ 15 years TBM defined as "definite", "probable" or "possible" Signed Informed Consent Definite TBM = at least one of the following criteria: acid-fast bacilli seen in CSF microscopy, positive CSF M. tuberculosis culture, or positive CSF M. tuberculosis commercial nucleic acid amplification test. Probable TBM = total modified Marais score ≥12 when neuroimaging is available, or ≥10 when neuroimaging is not available (at least 2 points should come from CSF or cerebral imaging criteria). Possible TBM = total modified Marais 6-11 when neuroimaging is available, or 6-9 when neuroimaging is not available. Exclusion criteria: > 5 days of TB treatment Renal failure (eGFR<30 ml/min, CKD-EPI formula). Neutrophil count < 0.6 x 109/L. Hemoglobin concentration < 8 g/dL. Total bilirubin > 2.6 times the Upper Limit of Normal Platelet count < 50 x 109/L. ALT > 5 times the Upper Limit of Normal. Clinical evidence of liver failure or decompensated cirrhosis. For women: more than 17 weeks pregnancy or breastfeeding. For patients without decrease level of consciousness (Glasgow Coma Scale = 15): Peripheral neuropathy scoring Grade 3 or above on the Brief Peripheral Neuropathy Score (BPNS). Documented M. tuberculosis resistance to rifampicin. Positive gram-stain, bacterial culture or cryptococcal antigen in the Cerebral Spinal Fluid. Evidence of active bleeding (hemoptysis, gastrointestinal bleeding, hematuria, intracranial bleeding). Inability to collect Cerebral Spinal Fluid, except for patients with confirmed tuberculosis (by rapid molecular test or culture) from another biological sample and clinical and/or CT scan evidence of meningitis. Major surgery within the last two weeks prior to inclusion. Ongoing chronic aspirin treatment (eg for cardiovascular risk). Current use of drugs contraindicated with study drugs and that cannot be safely stopped (see Appendix 1: Drugs contra-indicated with study drugs). In available history from patients: Evidence of past intracranial bleeding. Evidence of past of peptic ulceration. Evidence of recent (< 3 month) gastrointestinal bleeding. Known hypersensitivity contraindicating the use of study drugs . Evidence of porphyria. Evidence of hyperuricemia or gout. Any reason which at the discretion of the investigator would compromise safety and cooperation in the trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fabrice Bonnet, M.D., Ph.D.
Phone
+33 (0)5 56 79 58 26
Email
fabrice.bonnet@chu-bordeaux.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Xavier Anglaret, M.D., Ph.D.
Phone
+33 (0)5 57 57 12 58
Email
xavier.anglaret@u-bordeaux.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabrice Bonnet, M.D., Ph.D.
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cocody University Hospital
City
Abidjan
Country
Côte D'Ivoire
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Horo Kigninlman, Prof
Facility Name
Treichville University Hospital
City
Abidjan
Country
Côte D'Ivoire
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gisèle Kouakou, Prof.
Facility Name
Yopougon University Hospital
City
Abidjan
Country
Côte D'Ivoire
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thierry Odehoury-Koudou, Prof
Facility Name
University Hospital Joseph Raseta Befelatanana
City
Antananarivo
Country
Madagascar
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mamy Jean de Dieu Randria, Prof.
Facility Name
University Hospital Tambohobe
City
Fianarantsoa
Country
Madagascar
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rivonirina Andry Rakotoarivelo, Prof.
Facility Name
Morafeno University Hospital
City
Toamasina
Country
Madagascar
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphane Dimby Ralandison, Prof
Facility Name
Kayelitsha District Hospital
City
Cape Town
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Graeme Meintjes, Prof.
Facility Name
Mitchells Plain Hospital
City
Cape Town
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Graeme Meintjes, Prof.
Facility Name
New Somerset Hospital
City
Cape Town
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sean Wassermann, Dr
Facility Name
Dora Nginza Hospital
City
Port Elizabeth
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nowshad Alam, Dr
Facility Name
Livingstone and PE Central Hospitals
City
Port Elizabeth
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Black, Dr.
Facility Name
Mbarara Regional Reference Hospital
City
Mbarara
Country
Uganda
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Conrad Muzoora, Dr.
Facility Name
Regional Reference Hospital of Kabale
City
Mbarara
Country
Uganda
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marion Namutebi, Dr.

12. IPD Sharing Statement

Citations:
PubMed Identifier
36348453
Citation
Maitre T, Bonnet M, Calmy A, Raberahona M, Rakotoarivelo RA, Rakotosamimanana N, Ambrosioni J, Miro JM, Debeaudrap P, Muzoora C, Davis A, Meintjes G, Wasserman S, Wilkinson R, Eholie S, Nogbou FE, Calvo-Cortes MC, Chazallon C, Machault V, Anglaret X, Bonnet F. Intensified tuberculosis treatment to reduce the mortality of HIV-infected and uninfected patients with tuberculosis meningitis (INTENSE-TBM): study protocol for a phase III randomized controlled trial. Trials. 2022 Nov 8;23(1):928. doi: 10.1186/s13063-022-06772-1.
Results Reference
derived
Links:
URL
https://intense-tbm.org/
Description
INTENSE-TBM project website

Learn more about this trial

Intensified Tuberculosis Treatment to Reduce the Mortality of Patients With Tuberculous Meningitis

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