SMF to Improve Performance of Microscopy for the Diagnosis of PTB in a High HIV Prevalence Setting

NCT02701439 | Completed DMC

• 1 other identifier: SMF-01
• Study Type: observational
• Target: 1,050
• Locations: 1 country
• Sites: 1

Brief Summary

This study is investigating a better method to see if someone has tuberculosis (TB) as compared to the method that is being used now.

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of SMF method and Xpert MTB/RIF assay

  The primary endpoints of this laboratory-based study will be to determine the sensitivity and specificity of the SMF method and Xpert MTB/RIF assay, using manual MGIT liquid culture as the gold standard

  24 months

Study Arms (2)

HIV-infected

Enrollment of 740 HIV-infected adults with suspicion of pulmonary TB. Following the Ugandan National Tuberculosis and Leprosy Programme (NTLP) guidelines, all enrolled TB suspects will undergo the following standardized evaluation: * Abbreviated demographic and clinical evaluation * TB history and evaluation * Obtain three sputum samples - one early morning sample and two spot samples * HIV testing (and CD4 if positive) * Chest radiograph * Small membrane filtration intervention

Device: Small membrane filtration

HIV negative

Enrollment of 350 HIV negative adults with suspicion of pulmonary TB. Following the Ugandan National Tuberculosis and Leprosy Programme (NTLP) guidelines, all enrolled TB suspects will undergo the following standardized evaluation: * Abbreviated demographic and clinical evaluation * TB history and evaluation * Obtain three sputum samples - one early morning sample and two spot samples * HIV testing (and CD4 if positive) * Chest radiograph * Small membrane filtration intervention

Device: Small membrane filtration

Interventions

Small membrane filtration DEVICE

Following the Ugandan National Tuberculosis and Leprosy Programme (NTLP) guidelines, all enrolled TB suspects will undergo the following standardized evaluation: * Abbreviated demographic and clinical evaluation * TB history and evaluation * Obtain three sputum samples - one early morning sample and two spot samples * HIV testing (and CD4 if positive) * Chest radiograph * Small membrane filtration intervention will be administered to both arms

HIV negative; HIV-infected

Eligibility Criteria

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

Study Population

Adult patients with a suspected diagnosis of pulmonary TB attending two TB clinics in Mbarara, Uganda

You may qualify if:

• Adult (≥18 years)
• Pulmonary TB suspect defined as any person who presents with a productive cough for more than 2 weeks AND accompanied by at least one other respiratory symptom (shortness of breath, chest pains, hemoptysis) and/or constitutional symptom (loss of appetite, weight loss, fever, night sweats, and fatigue) (6).
• Willing to undergo TB evaluation and spontaneously expectorate ≥2 mL of sputum
• Willing to be tested for HIV, if no results available within past 6 months

You may not qualify if:

• Too ill or unable to provide written consent
• Treated with TB drugs for more than 3 days
• Extra-pulmonary or disseminated TB without pulmonary involvement (i.e. no cough)

Sponsors & Collaborators

• Epicentre: lead
• Boston University: collaborator
• University of Florida: collaborator

Study Sites (1)

Epicentre Mbarara Research Base

Mbarara, Mbarara, 1956, Uganda

Location

Biospecimen

Retention: SAMPLES WITH DNA

TB isolates from sputum samples

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Yap Boum II, PhD

  Epicentre

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 16, 2013
• First Posted: March 8, 2016
• Study Start: September 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: March 8, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)