Lipoarabinomannan (LAM) in Urine for Diagnosis of Pulmonary Tuberculosis in HIV Patients

Mansoura University214 enrolled

Overview

A diagnostic validity study in which urinary LAM was done in seropositive HIV patients with symptoms suggestive of TB who were included and investigated with battery of tests to reach the final diagnosis. The study was conducted at Mansoura Fever Hospital in collaboration with the Chest Department and Clinical Pathology Department, Mansoura University, Egypt, from January 2015 to October 2016. Ethical approval had been obtained from Medical Research Ethics Committee of Faculty of Medicine, Mansoura University (code no: MD/138). Approval from Egyptian Ministry of Health was taken (No: 1-2016/18). Patients signed their written consents after detailed explanation of the study protocol.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

214

Conditions

TB - Tuberculosis HIV

Interventions

Urinary LAM ELISA:DIAGNOSTIC_TEST

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * The study included seropositive HIV patients with a new diagnosis of either pulmonary or extra-pulmonary TB, and also included patients who were presented by symptoms suggestive for tuberculosis, changes in chest X ray that not improved by full course of antibiotics or positive tuberculin test ≥ 5 mm. Exclusion Criteria: * Patients on anti-TB drugs or negative screening for sero-positive HIV patients were excluded from the study.

Outcomes

Primary Outcomes

positive for TB

Concentration of urinary LAM was done in seropositive HIV patients

Time frame: day 1

Data from ClinicalTrials.gov

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