Wirelessly Observed Therapy in Comparison to Directly Observed Therapy for the Treatment of Tuberculosis
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/31/2017 |
| Start Date: | October 25, 2013 |
| End Date: | January 31, 2017 |
A Pilot Clinical Trial Characterizing Use of Ingestion Sensor Enabled Rifamate in Comparison to Directly Observed Therapy for the Treatment of Tuberculosis
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.
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.
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.
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.
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.
We found this trial at
2
sites
San Diego, California 92103
Principal Investigator: Sara H Browne, MD, MPH
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