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

TB - Tuberculosis HIV Clinical Trial

Official title:

Role of Detection of Lipoarabinomannan (LAM) in Urine for Diagnosis of Pulmonary Tuberculosis in HIV Patients; Egyptian Experience

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04813666
• Other study ID #: MansouraU LAM
• Status: Completed
• Phase: N/A
• Start date: January 1, 2015
• Est. completion date: October 1, 2016

Study information

• Verified date: March 2021
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: October 1, 2016
• Est. primary completion date: August 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• TB - Tuberculosis HIV
• Tuberculosis
• Tuberculosis, Pulmonary

Intervention

Diagnostic Test:
• Urinary LAM ELISA:

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	positive for TB	Concentration of urinary LAM was done in seropositive HIV patients	day 1