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:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-25 @ 2:31 AM
NCT ID:
NCT01856634
Eligibility Criteria:
Inclusion Criteria:
* Confirmed diagnosis of MDR-TB OR
* Presumptive diagnosis of MDR-TB including one of the following:
* Clinical specimen suggestive of TB
* Persistent cough lasting \> 2 weeks
* Fever, weight loss, and failure to thrive
* Findings on recent chest radiograph (prior to Visit 1) consistent with TB AND
* Household contact of a person with known MDR-TB or a person who died while appropriately taking drugs for sensitive TB OR
* On first-line TB treatment but with no clinical improvement
* Negative urine pregnancy test for female patients who have reached menarche
* Written informed consent/assent
Exclusion Criteria:
* Laboratory evidence of active hepatitis B or C
* Children with body weight \< 5.5 kg
* For patients with HIV co-infection, CD4 cell count ≤ 1000/mm3 for children 1-5 years old, and ≤ 1500/mm3 for children less than 1 year old
* History of allergy to metronidazole and any disease or condition in which metronidazole is required
* Use of amiodarone within 12 months or use of other predefined antiarrhythmic medications within 30 days prior to first dose of delamanid
* Serious concomitant conditions
* Preexisting cardiac conditions
* Abnormalities in Screening ECG (including AV block, BBB or hemi-block, QRS prolongation \> 120 msec, or QTcF \> 450 msec in both males and females)
* Concomitant condition such as renal impairment characterized by serum creatinine levels \>1.5 mg/dL, hepatic impairment (ALT or AST \> 3x ULN), or hyperbilirubinemia characterized by total bilirubin \> 2x ULN
* Current diagnosis of severe malnutrition or kwashiorkor
* Positive urine drug screen (Groups 1 and 2 only)
* Rifampicin and/or moxifloxacin within 1 week prior to the first dose of delamanid and/or any prior or concurrent use of bedaquiline
* Lansky Play Performance Score \< 50 (not applicable for children \< 1 year old) or Karnofsky Score \< 50
* Administered an IMP within 1 month prior to Visit 1
* Pregnant, breast-feeding, or planning to conceive or father a child within the timeframe described in the information consent form (Groups 1 and 2 only)
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
17 Years
Study:
NCT01856634
Study Brief:
Protocol Section:
NCT01856634