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NCT01582711 · ClinicalTrials.gov registry record · Phase 3
Study 33: Adherence to Latent Tuberculosis Infection Treatment 3HP SAT Versus 3HP DOT
A Phase 3 study, sponsored by Centers for Disease Control and Prevention.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,002
- Enrollment target
NCT01582711 is a Phase 3 study that has completed, run by Centers for Disease Control and Prevention. The registered enrollment target is 1,002 participants.
The verdict
NCT01582711, a Phase 3 study, has completed, sponsored by Centers for Disease Control and Prevention.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,002 participants
- Enrollment target
Study Summary
The study is an open label, multicenter, randomized (three arms: DOT (standard control), SAT, SAT with SMS reminders) controlled clinical trial. The trial is conducted in patients diagnosed with latent tuberculosis infection (LTBI) who are recommended for treatment. The primary objective is to evaluate adherence to a three-month (12-dose) regimen of weekly rifapentine and isoniazid (3RPT/INH) given by directly observed therapy (DOT) compared to self-administered therapy (SAT). The secondary objectives: * To compare the treatment completion rates between participants randomized to SAT without reminders versus SAT with weekly SMS reminders * To evaluate the timing of doses and patterns of adherence to once weekly RPT/INH among participants who complete treatment and those who discontinue therapy prior to completion. * To determine the availability and acceptability of using SMS reminders among all patients consenting to participate in the study. * To determine the toxicity and tolerability by comparing the rates of any drug-related grade 3 or 4 adverse events or death between the DOT arm and the SAT arms (both combined and individually) * To compare the frequency, timing, and causes for failure to complete treatment between the DOT arm and the SAT arms * To collect patient-specific cost data related to the 3 treatment arms * To describe the pattern of antituberculosis drug resistance among Mycobacterium tuberculosis strains cultured from participants who develop active TB.
Interventions
- BEHAVIORAL Self Administered Therapy (SAT)
- BEHAVIORAL SMS reminders
- DRUG isoniazid and rifapentine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,002 participants |
| Start Date | 2012-09 |
| Est. Completion | 2014-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01582711
The ClinicalTrials.gov registry entry for NCT01582711 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,002 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Centers for Disease Control and Prevention, which has 139 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Self Administered Therapy (SAT) is the first listed.
NCT01582711 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01582711 about?
NCT01582711 is a clinical study titled "Study 33: Adherence to Latent Tuberculosis Infection Treatment 3HP SAT Versus 3HP DOT". The study is an open label, multicenter, randomized (three arms: DOT (standard control), SAT, SAT with SMS reminders) controlled clinical trial. The trial is conducted in patients diagnosed with latent tuberculosis infection (LTBI) who are recommended for treatment. The primary objective is to evalu...
What is the current status of trial NCT01582711?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,002 participants. The study started on 2012-09. Estimated completion is 2014-10.
What interventions are being tested in trial NCT01582711?
The interventions under investigation include: Self Administered Therapy (SAT) (BEHAVIORAL), SMS reminders (BEHAVIORAL), isoniazid and rifapentine (DRUG).
Who is sponsoring clinical trial NCT01582711?
This trial is sponsored by Centers for Disease Control and Prevention, which has 139 total clinical trials registered on ClinicalTrials.gov.
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