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

Mansoura University

Status: Completed

Conditions: TB - Tuberculosis HIV

Treatments: Diagnostic Test: Urinary LAM ELISA:

Study type: Interventional

Funder types: Other

Identifiers

NCT04813666

MansouraU LAM

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 214 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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214 participants in 2 patient groups, including a placebo group

TB group

Active Comparator group

Treatment:

Diagnostic Test: Urinary LAM ELISA:

Non TB group

Placebo Comparator group

Treatment:

Diagnostic Test: Urinary LAM ELISA: