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ISRCTN
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ISRCTN49676555
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ClinicalTrials.gov identifier
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Public title
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A randomised, placebo-control phase III study to assess the safety and efficacy of the MPT64 patch test in the diagnosis of active tuberculosis (TB)
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Scientific title
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Acronym
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N/A
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Serial number at source
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SEQPTAT005
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Study hypothesis
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Cutaneous reaction to transdermal delivery of the Mycobacterium tuberculosis (MTB) specific protein MPT64 by means of a patch test will accurately identify individuals with active TB from amongst TB suspects.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Peru
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Disease/condition/study domain
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Active pulmonary tuberculosis.
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Participants - inclusion criteria
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TB suspects undergoing investigation at selected health centres for pulmonary TB within the National TB Control Programme of Peru.
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Participants - exclusion criteria
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1. Age less than 18 or greater than 65
2. Inability or unwillingness to provide written informed consent
3. Participation in a clinical trial of another investigational product within the preceding 6 months
4. Refusal to undergo voluntary counselling and testing for human immunodeficiency virus (HIV) infection
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Anticipated start date
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20/02/2005
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Anticipated end date
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01/05/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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624
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Interventions
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1. Diagnostic phase: application of a transdermal patch to each forearm, one containing placebo and the other MPT64 (study staff and patients blinded to allocation) with removal and reading of result at days 4 and 6. All patients receive full work-up for active pulmonary TB including clinical evaluation, two sputum cultures (each by two methods), chest radiograph and (on day 4) purified protein derivative (PPD) skin testing.
2. Follow-up phase: all participants are followed up at 3 months to verify correct baseline assignment as TB or non-TB; at months 9, 12, 15 and 18 all participants are investigated fully once more for TB (as above) and repeat patch testing is performed. In a subgroup of 30 consenting participants with positive reactions, skin punch biopsies are performed.
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Primary outcome measure(s)
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The objective is to assess the sensitivity and specificity of the MPT64 patch test in the diagnosis of pulmonary TB - the outcome of interest is therefore the concordance of patch test results with the results of the conventional gold-standard investigations performed concurrently.
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Secondary outcome measure(s)
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1. To assess the above performance characteristics in patient subgroups including those with smear-positive disease and smear-negative disease
2. To determine the effect (if any) of age, HIV status, PPD response upon patch test performance
3. To determine the response over time of both initial reactors and non-reactors and TB and non-TB patients
4. To characterize the histological response in patch test reactors
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Sources of funding
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Entirely funded by Sequella Inc.
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Trial website
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Publications
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Contact name
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Dr
David
Moore
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Address
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Universidad Peruana Cayetano Heredia
Honorio Delgado 430
San Martin de Porres
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City/town
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Lima
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Zip/Postcode
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Lima 31
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Country
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Peru
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Tel
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+511 382 3398
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Fax
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+511 464 0781
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Email
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davidajmoore@msn.com
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Sponsor
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Sequella Inc (USA)
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Address
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9610 Medical Center Drive
Suite 200
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City/town
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Rockville
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Zip/Postcode
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MD 20850
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Country
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United States of America
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Tel
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+1 301 762 7776
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Fax
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+1 301 762 7778
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Email
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katherinesacksteder@sequella.com
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Sponsor website:
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http://www.sequella.com
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Date applied
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13/09/2005
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Last edited
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29/09/2006
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Date ISRCTN assigned
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11/11/2005
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