Tuberculosis Clinical Trial
— MDRTB01Official title:
Genome Sequencing of MDR TB in Sputum
NCT number | NCT02245347 |
Other study ID # | 12.LO.1694 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | September 12, 2014 |
Last updated | September 17, 2014 |
Start date | April 2013 |
Drug resistant tuberculosis is a growing problem world wide. The current methods for diagnosis are time consuming and may delay diagnosis and treatment for many weeks. In this study the investigators wish to take sputum samples from patients to see if the investigators can validate a molecular DNA based process for prompt identification of drug resistant tuberculosis. The investigators wish to extract and amplify DNA from drug resistant tuberculosis and identify genes within it that confer resistance.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Any patient with smear positive tuberculosis who is capable to give informed consent will be offered to be included in the trial. Exclusion Criteria: - Any patient under 18 or who is unable to give informed consent will be excluded from this trial. Any patient who is unable to give a sputum sample. |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United Kingdom | St George's NHS Healthcare Trust | London |
Lead Sponsor | Collaborator |
---|---|
St George's Healthcare NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Identification and sequencing of mycobacterial DNA from sputum samples | To see if mycobacterial DNA can be identified and sequenced from sputum and if the results correlate with the Microtiter Plate Methods done phenotypically in the standard manner. | within 24 hours of sample collection | No |
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