Treatment of Latent Tuberculosis in Socially Marginalised... | NCT03266991

Studies
Treatment of Latent Tuberculosis in Socially Marginalised Citizens

NCT03266991

Sponsor

Aarhus University Hospital

Status

Terminated

Last Update Posted

Oct 12, 2023Actual

Enrollment

22Actual

Phase

Phase 4

Conditions

Compliance, Patient

Interventions

Rifapentine
Isoniazid

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Recruitment issues

Expanded Access Info

Start Date

Oct 27, 2017Actual

Primary Completion Date

Feb 9, 2023Actual

Completion Date

Feb 9, 2023Actual

First Submitted Date

Aug 11, 2017

First Submission Date that Met QC Criteria

Aug 28, 2017

First Posted Date

Aug 30, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 10, 2023

Last Update Posted Date

Oct 12, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

An open-label, randomised controlled trial comparing compliance to treatment for latent tuberculosis infection in socially marginalised citizens. Participants will be randomized to either daily isoniazid for 6 months or weekly rifapentine and isoniazid as directly observed therapy for twelve weeks.

Detailed Description

Eligible participants will be randomised to receive either daily isoniazid for 6 months with monthly visits for pill count, evaluation of adverse events and dispensing of isoniazid for the next month, or weekly doses of rifapentine and isoniazid for twelve weeks as direct observed therapy where the drugs are administered in the presence of a study nurse or doctor.

Control bloodsamples (ALAT, alkaline phosphatase, bilirubin, INR, haemoglobin, trombocytes and leukocyte differential count) will be taken at baseline and at least once during treatment in the rifapentine and isoniazid group and at least twice in the isoniazid-only group.

One year after treatment completion participants will be called in for evaluation for active tuberculosis.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RPT-INH	Experimental	Participants treated with weekly rifapentine and isoniazid for twelve weeks.	Drug: Rifapentine Drug: Isoniazid
control	Active Comparator	Participants treated with daily isoniazid for six months	Drug: Isoniazid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rifapentine	Drug	Treatment with weekly rifapentine and isoniazid as Directly Observed Therapy in 12 weeks	RPT-INH

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
adherence	adherence to treatment in the two groups measured by counting number of pills taken in each group.	2 years

Secondary Outcomes

Measure	Description	Time Frame
active tuberculosis	active tuberculosis within the study period. In case of suspected tuberculosis during the study the participant will be refered for examination by specialists. At 1 year follow-up participants will have a chest x-ray and physical examination by study doctor to screen for signs of active tuberculosis. If active tuberculosis is suspected further examinations will be performed by specialists.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Reporting to be homeless (independent of whether the person has an official address) or regularly seeking homeless shelters or public institutions to supply basic needs
LTBI defined by positive IGRA test
Found plausible by study doctor that the person has been exposed to tuberculosis within 2 years
Aged 18 years or older

Exclusion Criteria:

Previously treated for tuberculosis
Pregnant or breastfeeding
Active tuberculosis (evaluated by chest x-ray and examination by a trained doctor)
Unable to give informed consent
Tested positive for LTBI as part of contact investigation where the index case has or is suspected to have INH of RIF resistant TB
Known HIV on antiretroviral treatment
Porphyria
Known allergy to rifamycins or isoniazid
Known epilepsy
Known liver disease causing affected liver parameters (ALAT, alkaline phosphatase, bilirubin, INR)
Any lab abnormality, disease, concomitant medication or condition that, in the opinion of the investigator, excludes a person from participating

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christian Wejse, MD PHD	Aarhus University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept of Pulmonary Medicine		Aarhus		8000	Denmark
Dept of Pulmonary Medicine

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010349	Patient Compliance

Ancestor Terms

ID	Term
D010342	Patient Acceptance of Health Care
D000074822	Treatment Adherence and Compliance
D015438	Health Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C018421	rifapentine
D007538	Isoniazid

Ancestor Terms

ID	Term
D006834	Hydrazines
D009930	Organic Chemicals
D007539	Isonicotinic Acids
D000147	Acids, Heterocyclic

Browse Leaves

Not provided

Browse Branches

Not provided