Trial · NCT07301320
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Response (NTM Symptom Evaluation Instrument) at Day 84 | Day 1 to Day 84 | Improvement in severity of at least 50% of the symptoms present at baseline and no deterioration in severity of symptoms present at baseline |
| Primary | Sputum culture conversion by Day 84 | Day 1 to Day 84 | Defined as 3 consecutive negative cultures one month apart without intervening or subsequent positives |
| Primary | Decrease in semi-quantitative sputum culture counts at Day 84 | Day 1 to Day 84 | Defined as improvement in sputum colony count category as defined by Griffith et al, 2015 |
| Primary | Change from baseline in Quality of Life - Bronchiectasis (QOL-B) Respiratory Domain at Day 84 | Day 1 to Day 84 | QOL-B Domain scores range from 0 to 100, with higher scores indicating better health-related quality of life |
| Primary | Change from baseline in MACrO2 PRO at Day 84 | Day 1 to Day 84 | MACrO2 scores range from 0 to 100, with lower scores indicating better symptom-related quality of life |
| Primary | Sputum culture conversion by Day 56 | Day 1 to Day 56 | Defined as 2 consecutive negative cultures collected one month apart without intervening or subsequent positives |
| Secondary | Patient Global Impression of Change (PGI-C) at Day 84 | Day 1 to Day 84 | The Patient Global Impression of Change Scale has a minimum value of 1 and a maximum value of 7. For this scale, higher scores indicate a worse outcome. |
| Secondary | Patient Global Impression of Severity (PGI-S) at Day 84 | Day 1 to Day 84 | The Patient Global Impression of Severity Scale measures severity of a patient's overall status over the previous 7 days. The responses on this scale have a minimum value of 'None' and a maximum value of 'Very severe' related to severity. For this scale, higher scores ('Very severe') indicate a worse outcome. |
| Secondary | Physician Visual Analog Scale (VAS) - Global at Day 84 | Day 1 to Day 84 | The Physician Visual Analog Scale - Global has a minimum value of 0 and a maximum value of 10. For this scale, higher scores indicate a worse outcome. |
| Secondary | Physician Visual Analog Scale (VAS) - Respiratory at Day 84 | Day 1 to Day 84 | The Physician Visual Analog Scale - Respiratory has a minimum value of 0 and a maximum value of 10. For this scale, higher scores indicate a worse outcome. |
| Secondary | NTM Symptoms Scale (NTM-SS) Questionnaire at Day 84 | Day 1 to Day 84 | The Non-tuberculous Mycobacteria Symptoms Scale measures symptoms within the previous 7 days including respiratory, fatigue, temperature, appetite/weight, cognition/mood, and sleep. Questions on this scale have a minimum value of 'Never' and a maximum value of 'Always' related to the prevalence of symptoms. For this scale, higher scores ('Always') indicate a worse outcome. |
| Secondary | Time to growth in liquid medium | Day 1 to Day 84 | Measured at Days 14, 28, 42, 56, and 84 |
| Secondary | Time to first negative sputum culture | Day 1 to Day 84 | |
| Secondary | Proportion of patients with an on-treatment MABC isolate demonstrating decreasing sensitivity to EBO | Day 1 to Day 84 | |
| Secondary | Sputum culture conversion by Day 84 | Day 1 to Day 84 | Defined as 2 consecutive negative cultures one month apart without intervening or subsequent positives |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT07301320/registered