Genome Sequencing of Multidrug Resistant Tuberculosis (MDR TB) in Sputum

NCT02245347 | Unknown

• 1 other identifier: 12.LO.1694
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tuberculosis

Keywords

TB; Tuberculosis; MDR TB; Drug resistant TB

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patients with expected MDR TB

Eligibility Criteria

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

Study Population

Smear positive patients with confirmed or suspected TB

You may qualify if:

• Any patient with smear positive tuberculosis who is capable to give informed consent will be offered to be included in the trial.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St George's Healthcare NHS Trust: lead

Study Sites (1)

St George's NHS Healthcare Trust

London, SW180RE, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Sputum samples

MeSH Terms

Conditions

Tuberculosis; Tuberculosis, Multidrug-Resistant

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Central Study Contacts

Catherine Cosgrove, MBBS

CONTACT

+44 (0)2087252379; ccosgrov@sgul.ac.uk

Study Design

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

Study Record Dates

• First Submitted: September 12, 2014
• First Posted: September 19, 2014
• Study Start: April 1, 2013
• Primary Completion: April 1, 2016
• Last Updated: September 19, 2014

Record last verified: 2014-09

Locations

GB (1)