Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01371916
Other study ID # xijing004
Secondary ID
Status Completed
Phase N/A
First received June 8, 2011
Last updated August 18, 2014
Start date September 2010
Est. completion date January 2014

Study information

Verified date August 2014
Source Xijing Hospital
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Observational

Clinical Trial 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.


Description:

Read more »
Read more »

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Locations

Country Name City State
China Xijing Hospital Xi'an Shanxi

Sponsors (1)

Lead Sponsor Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
See also
  Status Clinical Trial Phase
Active, not recruiting NCT00433719 - Immediate Versus Deferred Antiretroviral Therapy for HIV-Associated Tuberculous Meningitis N/A
Completed NCT02237365 - A Pilot Study of Adjunctive Aspirin for the Treatment of HIV Negative Adults With Tuberculous Meningitis Phase 2
Not yet recruiting NCT02588196 - The Relationships Between Gene Polymorphisms of LTA4H and Dexamethasone Treatment for Tuberculous Meningitis Phase 4
Completed NCT03092817 - Adjunctive Corticosteroids for Tuberculous Meningitis in HIV-infected Adults (The ACT HIV Trial) Phase 3
Recruiting NCT03787940 - Optimizing Antituberculosis Therapy in Adults With Tuberculous Meningitis N/A
Not yet recruiting NCT05917340 - Intensified Short Course Regimen for TBM in Adults Phase 3
Completed NCT01802502 - Rifampicin Explorative PK Study for Tuberculous Meningitis Comparing Oral and Intravenous Preparation Phase 2
Recruiting NCT05636254 - Diagnostic Accuracy of Imaging Findings in TBM/Spinal Tubercular Arachnoiditis and Correlation With Outcomes
Recruiting NCT03898635 - Retrospective Real-word Study of Linezolid for the Treatment of Tuberculous Meningitis
Completed NCT05781646 - Xpert MTB/RIF Assay for Diagnosis of Tuberculous Meningitis (TBM) in Maharaj Nakorn Chiang Mai Hospital N/A
Active, not recruiting NCT03100786 - Leukotriene A4 Hydrolase Stratified Trial of Adjunctive Corticosteroids for HIV-uninfected Adults With Tuberculous Meningitis Phase 3
Recruiting NCT04145258 - Intensified Tuberculosis Treatment to Reduce the Mortality of Patients With Tuberculous Meningitis Phase 3
Recruiting NCT05383742 - Trial of a Six-Month Regimen of High-Dose Rifampicin, High-Dose Isoniazid, Linezolid, and Pyrazinamide Versus a Standard Nine-Month Regimen for the Treatment of Adults and Adolescents With Tuberculous Meningitis Phase 2
Completed NCT03226379 - Driving Reduced AIDS-associated Meningo-encephalitis Mortality N/A
Recruiting NCT05590455 - Tnf Inhibitors to Reduce Mortality in HIV-1 Infected PAtients With Tuberculosis meNIngitis Phase 2
Recruiting NCT04308928 - Evaluation of New Biomarker-based Approaches for Improving the Diagnosis of Childhood Tuberculous Meningitis