Evaluation of PCR Using DNA Extract From Slides and Filter Paper for the Detection of Tuberculosis and MDR-tuberculosis

NCT03137875 | Completed DMC

• 1 other identifier: HS 918
• Study Type: observational
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

Specimen transport from peripheral health structures to the National TB reference laboratory for MDR-TB identification presents a big challenge in term of sample management, safety, contamination and delays. Thus a system that allows specimen to be collected and shipped in a safely manner while reducing the possibilities of contamination, the cost of shipment and especially the time for detection of MDR-TB by using molecular methods would be very useful. Whereas the some studies show promising results for the development and standardization of simple specimen collection and transportation methods for molecular DST, more data is needed before these can be used in routine. The study described here aims at identifying a suitable method, in terms of adapted sample support (s) (slide, filter paper (FTA, Genocard ...)) and DNA extraction method. If one or several methods are found to give satisfying results, then a larger patient based evaluation of this (these) method(s) for molecular DST will be performed in a second phase. The protocol for the second phase will be prepared separately.

Conditions

Tuberculosis; Multi Drug Resistant Tuberculosis

Keywords

Tuberculosis; TB; MDR-TB; LIPA; filter paper; slides; MTBDR Plus

Outcome Measures

Primary Outcomes (1)

• proportion of positive samples for Mycobacterium tuberculosis detected by PCR from slides and filter papers among samples by microscopy

  Tests

  6 MONTHS

Secondary Outcomes (1)

• To assess the MTB extraction yield from smear-negative, low and high bacilli load specimens on slides, filter paper ( Genocardand FTA)

  6 MONTHS

Study Arms (3)

Patient with sputum smear positive 2+

patient who will have a positive diagnostic of tuberculosis using microscopy with a 2+ grade

patient smear positive scanty or 1+

patient who will have a positive diagnostic of tuberculosis using microscopy with a scanty or 1+ grade

patient smear negative

patient with a negative TB microscopy result

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will take place in the Mbarara Regional Referral Hospital (MRRH) located in Mbarara Municipality, Mbarara District, and south-west of Uganda. Patients suspected of TB are evaluated in the outpatient facility at the hospital or in the medical ward when admitted. Some samples will be collected from The Aid Support Organisation (TASO) Mbarara. TASO is located in the neighbourhood of MRRH and EMRB.

You may qualify if:

• TB suspect with cough more than 2 weeks

You may not qualify if:

• None

Sponsors & Collaborators

• Epicentre: lead
• Medecins Sans Frontieres, Netherlands: collaborator

Study Sites (1)

Epicentre Mbarara Research Base

Mbarara, Uganda

Location

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

Study Officials

• Yap JB Boum II, PhD

  Epicentre Mbarara

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2011
• First Posted: May 3, 2017
• Study Start: March 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 3, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)