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.: PACTR201411000881358 Date of Approval: 08/09/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title INTERFERON GAMMA RELEASE ASSAY AMONG PULMONARY TUBERCULOSIS PATIENTS AND CONTACTS
Official scientific title INTERFERON GAMMA RELEASE ASSAY AMONG PULMONARY TUBERCULOSIS PATIENTS AND CONTACTS
Brief summary describing the background and objectives of the trial Mycobacterium tuberculosis infection is a main threat to mankind, with one third of the world population being infected. Over nine million new cases of tuberculosis and two million deaths from this disease occur yearly worldwide. Early diagnosis and prompt treatment of patients with active pulmonary disease are the most important factors in reducing the morbidity, mortality, and incidence of TB. Diagnosis is presently based on clinical suspicion, radiological findings, and laboratory confirmation of bacilli through microbiological methods (smear microscopy for acid-fast bacillus [AFB] and/or culture). Smear microscopy for AFB is still the principal method for the detection of pulmonary TB in patients, mainly in regions where TB is highly endemic countries. Limitations of these traditional microbiological methods have led to the development of additional methods, such as the gamma interferon (IFN- ¿) release assay, as an aid in clinical and laboratory investigations of cases of human TB. Tests that detect T cells producing IFN- ¿ in response to early secreted antigenic target 6 (ESAT-6) and culture filtrate protein (CFP-10) now available on the market include the QuantiFERON-TB Gold (Cellestis Ltd., Carnegie, Victoria, Australia) and T SPOT-TB (Oxford Immunotec, Oxford, United Kingdom) assays. The QuantiFERON-TB Gold test has been approved by the U.S. Food and Drug Administration for the diagnosis of either latent or active TB infection. However, IGRAs were explicitly designed to replace the TST in diagnosis of LTBI and were not intended for active tuberculosis, which is a microbiological diagnosis. Furthermore, diagnosis and treatment of LTBI remains limited in scope in most low- and middle-income countries, where detection and management of active tuberculosis is of highest priority for national tuberculosis programs.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,PULMONARY TUBERCULOSIS
Sub-Disease(s) or condition(s) being studied Tuberculosis
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/03/2013
Actual trial start date 01/03/2013
Anticipated date of last follow up 31/12/2014
Actual Last follow-up date 31/12/2014
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 90
Recruitment status Closed to recruitment,follow-up continuing
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
Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group PULMONARY TUBERCULOSIS No dose Day 1: Sample 1 - Patient provided, under supervision, an ¿on-the-spot¿ sample - Three sputum samples ¿on the SPOT ¿ early MORNING ¿ on the SPOT¿ for microscopy. 45 Active-Treatment of Control Group
Control Group Contacts No dose Day 1: Sample 1 - Patient provided, under supervision, an ¿on-the-spot¿ sample - Three sputum samples ¿on the SPOT ¿ early MORNING ¿ on the SPOT¿ for microscopy. 45
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Confirmed Active pulmonary tuberculosis by ZN stain or sputum culture. Contacts with negative ZN smear Patients with extrapulmonary TB Pregnant females contacts to TB patients with duration of exposure more than two weeks Known allergy to TST 16 Year(s) 75 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 27/02/2013 Alexandria Governorate, Ministry of Health
Ethics Committee Address
Street address City Postal code Country
Fouad Street Aelxandria 21516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Quantiferon TB test in tube Day 1: Blood sample taken and measure at cut off value < 0.35IU
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
High institute of public health 165 Elhorreya avenue Alexandria 21516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
High institute of public health 165 Elhorreya avenue Alexandria 21516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor High institute of public health 165 Elhorreya avenue Alexandria 21516 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Soraya Ali El-Shazly Smouha Alexandria 21516 Egypt
Heba Sayed Ahmed Selim Loran Alexandria 21516 Egypt
Somaya Mohamed Hussein Sidi bisher Alexandria 21516 Egypt
Yousra Adel Elmaradny Loran Alexandria 21516 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Soraya Elshazly dr.soraya@hotmail.com 01105012781 Smouha
City Postal code Country Position/Affiliation
Alexandria 21516 Egypt Professor of Microbiology
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21516 Egypt Patient Information Manager
Role Name Email Phone Street address
Scientific Enquiries Heba Selim drhebaselim@yahoo.com 01001393153 -Loran
City Postal code Country Position/Affiliation
Alexandria 21516 Egypt Assistant Professor of Microbiology
REPORTING
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