Contact information
Type
Scientific
Primary contact
Dr David Moore
ORCID ID
Contact details
Universidad Peruana Cayetano Heredia
Honorio Delgado 430
San Martin de Porres
Lima
Lima 31
Peru
+511 382 3398
davidajmoore@msn.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SEQPTAT005
Study information
Scientific title
Acronym
Study hypothesis
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Diagnostic
Patient information sheet
Condition
Active pulmonary tuberculosis.
Intervention
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.
Intervention type
Drug
Phase
Phase III
Drug names
MTB specific protein MPT64
Primary outcome measures
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.
Secondary outcome measures
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
Overall trial start date
20/02/2005
Overall trial end date
01/05/2007
Reason abandoned
Eligibility
Participant inclusion criteria
TB suspects undergoing investigation at selected health centres for pulmonary TB within the National TB Control Programme of Peru.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
624
Participant exclusion criteria
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
Recruitment start date
20/02/2005
Recruitment end date
01/05/2007
Locations
Countries of recruitment
Peru
Trial participating centre
Universidad Peruana Cayetano Heredia
Lima
Lima 31
Peru
Sponsor information
Organisation
Sequella Inc (USA)
Sponsor details
9610 Medical Center Drive
Suite 200
Rockville
MD 20850
United States of America
+1 301 762 7776
katherinesacksteder@sequella.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Entirely funded by Sequella Inc.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary