Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-24 @ 6:47 PM
NCT ID:
NCT01960257
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01960257
Study Brief:
Protocol Section:
NCT01960257