Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202106822651688 Date of Registration: 29/06/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Role of detection of lipoarabinomannan (LAM) in urine for diagnosis of pulmonary tuberculosis in HIV patients; Egyptian experience
Official scientific title Role of detection of lipoarabinomannan (LAM) in urine for diagnosis of pulmonary tuberculosis in HIV patients; Egyptian experience
Brief summary describing the background and objectives of the trial Although, marked progress in HIV management, late presentation of cases with TB still represents a major threat to survival. The lack of rapid and accurate assays for HIV-associated TB has been a major hindrance to reducing deaths from these diseases in resource-limited settings. (3) The aim of this study was to evaluate the role of urinary LAM in diagnosis of active tuberculosis in patients with HIV in relation to different diagnostic tools to help early management for improving outcome.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Tuberculosis
Purpose of the trial Early detection /Screening
Anticipated trial start date 01/01/2015
Actual trial start date 01/10/2016
Anticipated date of last follow up 01/07/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 214
Actual target sample size (number of participants) 96
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group laboratory test 1 day 13- Urinary LAM ELISA: The test has been done in Clinical Pathology Department of Mansoura Faculty of Medicine 23
Control Group laboratory 1 day lam screening in non tuberculosis group 73 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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. Patients on anti-TB drugs or negative screening for sero-positive HIV patients were excluded from the study. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/01/2015 Mansoura Faculty of Medicine Institutional Research Board
Ethics Committee Address
Street address City Postal code Country
algomhorya street mansoura 35511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome tb diagnosis 1 day
Secondary Outcome final diagnosis 1 month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
mansoura university algomhorya street mansoura 35511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Asem Hewidy hay algamaa street mansoura Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor asem hewidy ebad elrahman mansoura Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
no callaborators no no Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Asem Hewidy ahewidy@yahoo.com 00201005210674 ebad elrahman
City Postal code Country Position/Affiliation
mansoura Egypt Associate professor
Role Name Email Phone Street address
Public Enquiries Nessrin Shalaby nesrien@mans.edu.eg 00201227931334 algomhorya
City Postal code Country Position/Affiliation
mansoura Egypt professor
Role Name Email Phone Street address
Scientific Enquiries Nagwa Elhalawany negm_gogo2010@yahoo.com 00201222206704 algomhorya
City Postal code Country Position/Affiliation
mansoura Egypt consultant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes retrospective study registeration the study already finished and ipd can be shared Clinical Study Report,Study Protocol available now requestProposal should be directed to xxx@yyy. To gain access, data requestors will need to send email to: ahewidy@yahoo.com sign a data access agreement. Data are available for 5 yearss will be approved for any researches
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 05/02/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 05/02/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information