Trial · NCT05590455
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 3-month all-cause mortality | 3 months | |
| Secondary | 3-month incidence of severe/life threatening bacterial infections and opportunistic infections | 3 months | |
| Secondary | 3-month incidence of grade 3 and 4 adverse reactions and those leading to ART or anti tuberculosis treatment (ATT) interruption | 3 months | |
| Secondary | 3-month incidence of all grade 3 and 4 adverse events | 3 months | |
| Secondary | 9-month and 12-month all-cause mortality | 9 months and 12 months | |
| Secondary | 9-month disability free survival (using Rankin score) | 9 months | MODIFIED RANKIN SCORE (MRS) 0: No symptoms at all 1. No significant disability despite symptoms; able to carry out all usual duties and activities 2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. Moderate disability; requiring some help, but able to walk without assistance 4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. Dead |
| Secondary | 3-month and 9-month incidence of all grade infectious diseases and opportunistic infections | 3 months and 9 months | |
| Secondary | 9-month neurological disability score (Rankin score) | 9 months | MODIFIED RANKIN SCORE (MRS) 0: No symptoms at all 1. No significant disability despite symptoms; able to carry out all usual duties and activities 2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. Moderate disability; requiring some help, but able to walk without assistance 4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. Dead |
| Secondary | Time to and severity of TB-associated paradoxical immune reconstitution inflammatory syndrome (IRIS) between D0 and 9 months | up to 9 months | |
| Secondary | Time to discharge | up to 9 months | |
| Secondary | Cerebrospinal fluid (CSF) pleocytosis/protein/glucose levels at W0, W1 and W4 | week 0, week1 and week4 | |
| Secondary | CSF mycobacterial cultures negativation (culture conversion), time to culture positivity and cycle threshold (GeneXpert Mycobacterium tuberculosis/Rifampicin Ultra) at W1, W4, | week1 and week4 | |
| Secondary | Proportion of patients with HIV-1 RNA<50 copies/mL at 9 months | 9 months | |
| Secondary | CD4 counts at 9 months (and gain from baseline) | 9 months | |
| Secondary | Inflammatory biomarkers and cytokines profiles in CSF at W0, W1, W4 | week 0, week1 and week4 | |
| Secondary | Inflammatory biomarkers in blood at W0, W4, W10, M6 and M9 | week 0, week4, week10, 6 months and 9 months | |
| Secondary | Cytokines profiles in blood at W0, W4, W10, M6 and M9 | week 0, week4, week10, 6 months and 9 months | |
| Secondary | Proportion of participants with possible, probable or definite TBM diagnosis at pre-inclusion according to Marais score | Pre-inclusion | Evaluation of TBM diagnosis and differential diagnoses in all pre-included participants: Proportion of participants with possible, probable or definite TBM diagnosis at pre-inclusion according to Marais score |
| Secondary | Proportion of participants with other CNS disease (opportunistic infections or other neurological conditions) | Pre-inclusion | Evaluation of TBM diagnosis and differential diagnoses in all pre-included participants: Proportion of participants with other CNS disease (opportunistic infections or other neurological conditions) |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05590455/registered