Diagnosis of Tuberculous Meningitis by ESAT-6 in CSF

NCT01371916 | Completed

• 1 other identifier: xijing004
• Study Type: observational
• Target: 316
• Locations: 1 country
• Sites: 1

Brief Summary

Early and reliable diagnosis of tuberculous meningitis (TBM) still poses a great challenge. One of the underlying difficulties is due to the fact that tubercle bacilli are mainly not present in the cerebrospinal fluid (CSF) but in the phagocytotic macrophages. The present study was designed to demonstrate early secretory antigenic target 6 (ESAT-6), a mycobacterium-specific antigens, in the macrophages in infected CSF samples and compare the efficiency of this antigen in the laboratory diagnosis of TBM.

Conditions

Tuberculous Meningitis

Keywords

tuberculous meningitis; early secretory antigenic target 6; diagnosis

Outcome Measures

Primary Outcomes (1)

• the positive percentage of total macrophages

  CSF smears from all patients were prepared and stained by standard immunocytological methods to examine the presence of ESAT-6. These negative controls did not have demonstrable staining (not shown). Positive staining was defined as visualization of yellow brown granules in the cytoplasm of macrophages. Positive and negative stained cells were counted in well-distributed visual fields.

  2 days

Study Arms (2)

ESAT-6 positive

ESAT-6 negative

Eligibility Criteria

• Age: 14 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All the patients described in this study were admitted to the Department of Neurology, Xijing Hospital of the Fourth Military Medical University, Xi'an, Shaanxi, China.

You may qualify if:

• Patients older than 14 years of age
• Suspected meningitis within the previous four weeks

You may not qualify if:

• Entertained a final diagnosis other than infectious meningitis
• Were under anti-tuberculosis therapy on admission
• Not obtained consent from either the patients or their legal surrogates

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital

Xi’an, Shanxi, 710032, China

Location

MeSH Terms

Conditions

Tuberculosis, Meningeal; Disease

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; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gang Zhao, Dr.

  Xijing Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2011
• First Posted: June 13, 2011
• Study Start: September 1, 2010
• Primary Completion: November 1, 2013
• Study Completion: January 1, 2014
• Last Updated: August 20, 2014

Record last verified: 2014-08

Locations

CN (1)