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)
ISRCTN | ISRCTN49676555 |
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DOI | https://doi.org/10.1186/ISRCTN49676555 |
Secondary identifying numbers | SEQPTAT005 |
- Submission date
- 13/09/2005
- Registration date
- 11/11/2005
- Last edited
- 12/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr David Moore
Scientific
Scientific
Universidad Peruana Cayetano Heredia
Honorio Delgado 430
San Martin de Porres
Lima
Lima 31
Peru
Phone | +511 382 3398 |
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davidajmoore@msn.com |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Diagnostic |
Scientific title | 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) |
Study objectives | 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(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | 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 |
Pharmaceutical study type(s) | |
Phase | Phase III |
Drug / device / biological / vaccine name(s) | MTB specific protein MPT64 |
Primary outcome measure | 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 study start date | 20/02/2005 |
Completion date | 01/05/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 624 |
Total final enrolment | 512 |
Key inclusion criteria | TB suspects undergoing investigation at selected health centres for pulmonary TB within the National TB Control Programme of Peru. |
Key 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 |
Date of first enrolment | 20/02/2005 |
Date of final enrolment | 01/05/2007 |
Locations
Countries of recruitment
- Peru
Study participating centre
Universidad Peruana Cayetano Heredia
Lima
Lima 31
Peru
Lima 31
Peru
Sponsor information
Sequella Inc (USA)
Industry
Industry
9610 Medical Center Drive
Suite 200
Rockville
MD 20850
United States of America
Phone | +1 301 762 7776 |
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katherinesacksteder@sequella.com | |
Website | http://www.sequella.com |
https://ror.org/0287vk548 |
Funders
Funder type
Industry
Entirely funded by Sequella Inc.
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 01/06/2018 | 12/01/2021 | Yes | No |
Editorial Notes
12/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.