Xpert MTB/RIF Assay for Diagnosis of Tuberculous Meningitis (TBM) in Maharaj Nakorn Chiang Mai Hospital

NCT05781646 | Completed

• 1 other identifier: CMUXpertTBM
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief Summary

Early diagnosis and appropriate treatment of tuberculous meningitis (TBM) are crucial steps to reduce morbidity and mortality. The WHO recommended to use Xpert MTB/RIF assay to diagnose pulmonary TB, pediatrics TB, extra pulmonary TB and rifampicin resistance. However, the data of accuracy in diagnosis of TBM is still lacking. This study aimed to find out the diagnostic performance of Xpert MTB/RIF assay for the diagnosis of tuberculous meningitis, especially in patients who presented with subacute lymphocytic meningitis.

Conditions

Tuberculous Meningitis

Keywords

Xpert MTB/RIF; Tuberculous Meningitis

Outcome Measures

Primary Outcomes (1)

• Detection of M. tuberculosis from CSF specimen

  Diagnostic values of Xpert MTB/RIF for detecting M. tuberculosis from CSF

  2 years

Study Arms (1)

Xpert

EXPERIMENTAL

Centrifuged CSF sent for Xpert MTB/RIF

Diagnostic Test: Xpert MTB/RIF

Interventions

Xpert MTB/RIF DIAGNOSTIC_TEST

CSF samples was centrifuged at 3,000 - 4,000 X g for 15 minutes. Supernatant was removed to leave a 1-ml precipitate, which was then used for Ziehl-Neelsen AFB staining (100 μl), inoculation of MGIT culture (100 μl), and Xpert MTB/RIF testing (800 μl).

Xpert

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of meningitis symptoms and signs including one or more of the following: headache, irritability, vomiting, fever, neck stiff ness, convulsions, focal neurological deficits, altered consciousness, or lethargy at least 5 days prior to admission, plus
• CSF with abnormalities of at least two of these three characters;
• Lymphocytic pleocytosis (≥ 50%)
• More than 40 mg/ml of protein
• Lower than 0.5 of CSF: blood sugar ratio

You may not qualify if:

• Contraindicated in lumbar puncture
• Positive for cryptococcal antigen in the CSF.

Sponsors & Collaborators

• Chiang Mai University: lead

Related Publications (4)

• Marais S, Thwaites G, Schoeman JF, Torok ME, Misra UK, Prasad K, Donald PR, Wilkinson RJ, Marais BJ. Tuberculous meningitis: a uniform case definition for use in clinical research. Lancet Infect Dis. 2010 Nov;10(11):803-12. doi: 10.1016/S1473-3099(10)70138-9. Epub 2010 Sep 6.

  PMID: 20822958 BACKGROUND

• Marx GE, Chan ED. Tuberculous meningitis: diagnosis and treatment overview. Tuberc Res Treat. 2011;2011:798764. doi: 10.1155/2011/798764. Epub 2011 Dec 21.

  PMID: 22567269 BACKGROUND

• Nhu NT, Heemskerk D, Thu do DA, Chau TT, Mai NT, Nghia HD, Loc PP, Ha DT, Merson L, Thinh TT, Day J, Chau Nv, Wolbers M, Farrar J, Caws M. Evaluation of GeneXpert MTB/RIF for diagnosis of tuberculous meningitis. J Clin Microbiol. 2014 Jan;52(1):226-33. doi: 10.1128/JCM.01834-13. Epub 2013 Nov 6.

  PMID: 24197880 BACKGROUND

• Patel VB, Theron G, Lenders L, Matinyena B, Connolly C, Singh R, Coovadia Y, Ndung'u T, Dheda K. Diagnostic accuracy of quantitative PCR (Xpert MTB/RIF) for tuberculous meningitis in a high burden setting: a prospective study. PLoS Med. 2013 Oct;10(10):e1001536. doi: 10.1371/journal.pmed.1001536. Epub 2013 Oct 22.

  PMID: 24167451 BACKGROUND

MeSH Terms

Conditions

Tuberculosis, Meningeal

Condition Hierarchy (Ancestors)

Meningitis, Bacterial; Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Tuberculosis, Central Nervous System; Tuberculosis, Extrapulmonary; Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Model Details: All patients older than 15 years old with subacute lymphocytic meningitis presenting to the internal medicine clinics of Maharaj Nakorn Chiang Mai hospital between January 2015 and March 2016 were recruited for the study.

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: March 23, 2023
• Study Start: January 1, 2015
• Primary Completion: March 30, 2016
• Study Completion: December 31, 2016
• Last Updated: March 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share