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
Protocol serial number	SEQPTAT005
Sponsor	Sequella Inc (USA)
Funder	Entirely funded by Sequella Inc.

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Phase III
Drug / device / biological / vaccine name(s)	MTB specific protein MPT64
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	01/05/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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.