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Wirelessly Observed Therapy in Comparison to Directly Observed Therapy for the Treatment of Tuberculosis

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ClinicalTrials.gov Identifier: NCT01960257
Recruitment Status : Completed
First Posted : October 10, 2013
Last Update Posted : August 30, 2017
Sponsor:
Collaborators:
Department of Health and Human Services
Proteus Digital Health, Inc.
Information provided by (Responsible Party):
University of California, San Diego

Brief Summary:

This study uses an ingestion sensor and a wearable sensor (worn as a patch on the skin), which are new Proteus Digital Health (PDH) technologies approved by the FDA, to collect information about patients taking their TB medications. The wearable sensor records information, which is uploaded wirelessly to a mobile device and then to a secure computer. Together the sensors and the mobile device transmitting the information to the study computer are called a digital health feedback system (DHFS), which gives healthcare providers information about when patients have taken their TB medications. The advantage of the DHFS is that patients can take their medication where and when it is convenient for them, and do not have to wait for a nurse to directly observe them taking their medication.

The purpose of this study is to find out if using these new technologies works as well as the standard method of observing in person when patients take their TB medications. This study will also look at the costs of using a DHFS for TB medications, what patients and healthcare providers think about using it, and other factors that can determine when one approach works better than another.

This study has two parts. For the first part of the study (Step I), patients will have an initial screening visit and then, in one two-week period, they will have 4 study visits at the UCSD AntiViral Research Center (AVRC) and routine visits from Public Health Services (PHS) workers. This part of the study is designed to confirm that the DHFS is working correctly and is accurately collecting information about each dose of medication that patients take, and to understand what patients and healthcare providers think about using the DHFS.

If patients are eligible for the second part of the study (Step II) and want to continue, that will last another 8-14 weeks with an additional 4 study visits at the AVRC. In the second part of the study, patients will be randomized into one of the following two groups.

Group 1: TB treatment is monitored by continued use of the DHFS

Group 2: TB treatment is monitored by the standard methods used by PHS (DOT)

The second part of the study is designed to compare these two methods of observing patients taking their TB medications, what the relative costs of these methods are , and the perception by patients and/or healthcare providers of the ease of use of the novel technology.


Condition or disease Intervention/treatment Phase
Tuberculosis Device: Digital Health Feedback System Other: SOC DOT Phase 4

Detailed Description:

PHARMACOKINETIC (PK) SUBSTUDY

The purpose of the PK substudy is to prospectively evaluate the pharmacokinetic parameters of isoniazid (INH) and rifampin (RIF) concentrations derived from dosing with Rifamate when given in native format compared to over encapsulated, ingestion sensor-enabled format.

The UCSD substudy aims to co-enroll 12 patients with Phase 1- the two-week investigation period of the characteristics of use of DHFS and patient acceptability. These subjects will be randomized to start on either Phase 1 or on two weeks of native Rifamate followed by 24-hour PK sampling.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Pilot Clinical Trial Characterizing Use of Ingestion Sensor Enabled Rifamate in Comparison to Directly Observed Therapy for the Treatment of Tuberculosis
Actual Study Start Date : October 25, 2013
Actual Primary Completion Date : January 31, 2017
Actual Study Completion Date : January 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Arm Intervention/treatment
Experimental: DHFS with IS-RM
Digital Health Feedback System (DHFS) Rifamate (combination of isoniazid 150 mg and rifampin 300 mg) over-encapsulated with ingestion sensor - 2 capsules orally daily (QD) administered orally preferably on an empty stomach first thing in the morning for 10-16 weeks, depending on time left to complete TB treatment.
Device: Digital Health Feedback System
This intervention uses an ingestion sensor and a wearable sensor (worn as a patch on the skin), which are new technologies approved by the FDA, to collect information about patients taking their TB medications. The wearable sensor records information, which is uploaded wirelessly to a mobile device and then to a secure computer. Together the sensors and the mobile device transmitting the information to the study computer are called a digital health feedback system (DHFS), which provides information about when patients have taken their TB medications.
Other Name: DHFS

Active Comparator: SOC DOT
Isoniazid 300 mg -1 tablet orally QD plus rifampin 300 mg - 2 capsules orally QD, OR Rifamate (combination of isoniazid 150 mg and rifampin 300 mg) - 2 capsules orally QD preferably on an empty stomach first thing in the morning for 10-16 weeks, depending on time left to complete TB treatment.
Other: SOC DOT



Primary Outcome Measures :
  1. Step 1: Positive Detection Accuracy (PDA) [ Time Frame: 2 weeks ]
    Determine positive detection accuracy (PDA, direct confirmation of TB medication ingestion) of the DHFS when compared to a healthcare worker witnessing actual TB medication ingestion.

  2. Step 2: Percentage of Witnessed Doses [ Time Frame: 16 weeks ]
    Determine the percentage of witnessed doses by DHFS and standard of care (SOC), respectively.


Secondary Outcome Measures :
  1. Characterize subject responses to post-study questionnaires to collect information regarding their experience with the DHFS and the usability of the system, using summary statistics. [ Time Frame: 16 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Basic competency in understanding written and verbal information as it applies to DHFS use.
  • Persons undergoing treatment for TB that includes at least isoniazid and rifampin at the time of entry to Phase 1; of note, patients must be sputum smear negative at the time of study entry.
  • Laboratory values obtained by screening laboratories within 30 days of entry:

    • Absolute neutrophil count (ANC) >= 1,000/mm3.
    • Hemoglobin >= 9.0 g/dL.
    • Platelet count >= 75,000/mm3.
    • AST (SGOT), ALT (SGPT), and alkaline phosphatase <= 3 x ULN.
    • Total bilirubin <= 1.5 x ULN and direct bilirubin.
  • Females of childbearing potential must agree to use contraception throughout the study period.
  • Men and women age >= 18 years.
  • Eligible for anti-mycobacterial medications and in possession of prescriptions for isoniazid and rifampin, or Rifamate, as appropriate.
  • Willing to follow all protocol requirements.
  • Ability to use mobile device per investigator determination, and to wear PDH wearable sensor (i.e., no skin conditions precluding use).
  • Ability and willingness of subjects to give written informed consent.

Exclusion Criteria

  • Female who is pregnant or breast-feeding, or of childbearing potential and has a tuberculin positive test at screening and disagrees to use contraception throughout the study period.
  • Use of any of the prohibited medications or other non-informed medications within 30 days of study entry.
  • Known hypersensitivity to any of the study drugs.
  • Known sensitivity to skin adhesives.
  • Serious illness requiring systemic treatment and/or hospitalization until subject either completes therapy or is clinically stable on therapy, in the opinion of the investigator, for at least 30 days prior to study entry (Day 0).
  • Evidence of any anti-mycobacterial resistance, clinical or genetic, prior to study entry. Resistance testing results must be available for review by the site investigator and study protocol team prior to enrollment to ensure that no exclusionary resistance exists.
  • Active drug or alcohol use, or dependence, or other conditions that, in the opinion of the site investigator, would interfere with adherence to study requirements.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01960257


Locations
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United States, California
UCSD AntiViral Research Center
San Diego, California, United States, 92103
San Diego County Public Health Services
San Diego, California, United States, 92110
Sponsors and Collaborators
University of California, San Diego
Department of Health and Human Services
Proteus Digital Health, Inc.
Investigators
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Study Chair: Sara Browne, MD, MPH University of California, San Diego

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Responsible Party: University of California, San Diego
ClinicalTrials.gov Identifier: NCT01960257     History of Changes
Other Study ID Numbers: AHF TB 001
First Posted: October 10, 2013    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017

Keywords provided by University of California, San Diego:
tuberculosis
tuberculosis treatment
wirelessly observed therapy
proteus digital health
digital health feedback system

Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections