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
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

Universidad Peruana Cayetano Heredia
Honorio Delgado 430
San Martin de Porres
Lima
Lima 31
Peru

Phone +511 382 3398
Email davidajmoore@msn.com

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeDiagnostic
Scientific titleA 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 objectivesCutaneous 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) studiedActive pulmonary tuberculosis.
Intervention1. 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 typeDrug
Pharmaceutical study type(s)
PhasePhase III
Drug / device / biological / vaccine name(s)MTB specific protein MPT64
Primary outcome measureThe 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 measures1. 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 date20/02/2005
Completion date01/05/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants624
Total final enrolment512
Key inclusion criteriaTB suspects undergoing investigation at selected health centres for pulmonary TB within the National TB Control Programme of Peru.
Key exclusion criteria1. 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 enrolment20/02/2005
Date of final enrolment01/05/2007

Locations

Countries of recruitment

  • Peru

Study participating centre

Universidad Peruana Cayetano Heredia
Lima
Lima 31
Peru

Sponsor information

Sequella Inc (USA)
Industry

9610 Medical Center Drive
Suite 200
Rockville
MD 20850
United States of America

Phone +1 301 762 7776
Email katherinesacksteder@sequella.com
Website http://www.sequella.com
ROR logo "ROR" https://ror.org/0287vk548

Funders

Funder type

Industry

Entirely funded by Sequella Inc.

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.