Condition category
Infections and Infestations
Date applied
13/09/2005
Date assigned
11/11/2005
Last edited
29/09/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.sequella.com

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

Publication citations

Additional files

Editorial Notes