Trial · NCT02372383
Improving Treatment of Nontuberculous Mycobacterial Infection in Cystic Fibrosis
NCT02372383, Not applicable, Completed, University of Colorado, Denver; results first posted 2021-02-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Improving Treatment of Nontuberculous Mycobacterial Infection in Cystic Fibrosis. Trials, record NCT02372383. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02372383
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Improving Treatment of Nontuberculous Mycobacterial Infection in Cystic Fibrosis
- NCT number
- NCT02372383
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 31 participants, actual
- Lead sponsor
- University of Colorado, Denver
- Conditions
- Cystic Fibrosis
- Interventions
- Ethambutol, Rifampin, Azithromycin, Pancrelipase
- First posted
- 2015-02-26
- Last updated
- 2021-02-11
- Results first posted
- 2021-02-11
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Median Maximal Drug Concentration (Cmax) | 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post dose | Cmax of the oral antimycobacterial drugs (azithromycin, rifampin and ethambutol) under both fasting conditions and when taken with food plus supplemental pancreatic enzymes in subjects with pancreatic insufficient CF, compared to healthy controls. |
| Secondary | Other PK Measures: Median Time to Maximal Drug Concentration (Tmax) | 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post dose | Tmax of the oral antimycobacterial drugs (azithromycin, rifampin and ethambutol) under both fasting conditions and when taken with food plus supplemental pancreatic enzymes in subjects with pancreatic insufficient CF, compared to healthy controls |
| Secondary | Other PK Measures: Half-life (t1/2) | 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post dose | t1/2 of the oral antimycobacterial drugs (azithromycin, rifampin and ethambutol) under both fasting conditions and when taken with food plus supplemental pancreatic enzymes in subjects with pancreatic insufficient CF, compared to healthy controls |
| Secondary | Other PK Measures: Drug Clearance | 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post dose | drug clearance of the oral antimycobacterial drugs (azithromycin, rifampin and ethambutol) under both fasting conditions and when taken with food plus supplemental pancreatic enzymes in subjects with pancreatic insufficient CF, compared to healthy controls Reported here are the Median (range) CL in the CF fasting state compared to HC for Rifampin. |
| Secondary | Other PK Measures: Volume of Distribution (Vd) | 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post dose | Vd of the oral antimycobacterial drugs (azithromycin, rifampin and ethambutol) under both fasting conditions and when taken with food plus supplemental pancreatic enzymes in subjects with pancreatic insufficient CF, compared to healthy controls |
| Secondary | Covariates of PK Measures: C-reactive Protein (CRP) | baseline | Median Concentration of C-reactive Protein. Begin to investigate the influence of inflammation, host characteristics, and drug metabolism on the PK of the antimycobacterial drugs. |
| Secondary | Covariates of PK Measures: Circulating Neutrophil Count | baseline | Circulating neutrophil count. Begin to investigate the influence of inflammation, host characteristics, and drug metabolism on the PK of the antimycobacterial drugs |
| Secondary | Covariates of PK Measures: Body Mass Index | baseline | Body mass index (BMI). Begin to investigate the influence of inflammation, host characteristics, and drug metabolism on the PK of the antimycobacterial drugs |
| Secondary | Covariates of PK Measures: Creatinine | baseline | Creatinine. Begin to investigate the influence of inflammation, host characteristics, and drug metabolism on the PK of the antimycobacterial drugs |
| Secondary | Area Under the Curve (AUC) | 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post dose | AUC of the oral antimycobacterial drugs (azithromycin, rifampin and ethambutol) under both fasting conditions and when taken with food plus supplemental pancreatic enzymes in subjects with pancreatic insufficient CF, compared to healthy controls. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Median Maximal Drug Concentration (Cmax) | 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post dose | mg/L | MEDIAN | |
| SECONDARY | Other PK Measures: Median Time to Maximal Drug Concentration (Tmax) | 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post dose | hours | MEDIAN | |
| SECONDARY | Other PK Measures: Half-life (t1/2) | 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post dose | hours | MEDIAN | |
| SECONDARY | Other PK Measures: Drug Clearance | 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post dose | L/h | MEDIAN | |
| SECONDARY | Other PK Measures: Volume of Distribution (Vd) | 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post dose | L | MEDIAN | |
| SECONDARY | Covariates of PK Measures: C-reactive Protein (CRP) | baseline | This Outcome Measure was only analyzed at the Fasting period and was not collected during the Food period of the study. Therefore, 0 participants are analyzed for the CF Food arm for this Outcome Measure. | mg/dL | MEDIAN |
| SECONDARY | Covariates of PK Measures: Circulating Neutrophil Count | baseline | This Outcome Measure was only analyzed at the Fasting period and was not collected during the Food period of the study. Therefore, 0 participants are analyzed for the CF Food arm for this Outcome Measure. | 10^3 cells/uL | MEDIAN |
| SECONDARY | Covariates of PK Measures: Body Mass Index | baseline | This Outcome Measure was only analyzed at the Fasting period and was not collected during the Food period of the study. Therefore, 0 participants are analyzed for the CF Food arm for this Outcome Measure. | kg/m^2 | MEDIAN |
| SECONDARY | Covariates of PK Measures: Creatinine | baseline | This Outcome Measure was only analyzed at the Fasting period and was not collected during the Food period of the study. Therefore, 0 participants are analyzed for the CF Food arm for this Outcome Measure. | mg/dL | MEDIAN |
| SECONDARY | Area Under the Curve (AUC) | 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post dose | mg*h/L | MEDIAN |
Source ClinicalTrials.gov
Results by group62
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Median Maximal Drug Concentration (Cmax) | Healthy Controls | Rifampin | 16.56 | Full Range 10.2 to 27.0 | mg/L |
| Median Maximal Drug Concentration (Cmax) | CF Fasting | Rifampin | 12.5 | Full Range 6.6 to 21.9 | mg/L |
| Median Maximal Drug Concentration (Cmax) | CF Food | Rifampin | 11.2 | Full Range 4.7 to 14.5 | mg/L |
| Median Maximal Drug Concentration (Cmax) | Healthy Controls | Ethambutol | 3.0 | Full Range 2.3 to 4.7 | mg/L |
| Median Maximal Drug Concentration (Cmax) | CF Fasting | Ethambutol | 4.2 | Full Range 1.1 to 6.8 | mg/L |
| Median Maximal Drug Concentration (Cmax) | CF Food | Ethambutol | 4.3 | Full Range 1.0 to 5.7 | mg/L |
| Median Maximal Drug Concentration (Cmax) | Healthy Controls | Azithromycin | 1.1 | Full Range 0.6 to 2.1 | mg/L |
| Median Maximal Drug Concentration (Cmax) | CF Fasting | Azithromycin | 2.0 | Full Range 0.1 to 5.3 | mg/L |
| Median Maximal Drug Concentration (Cmax) | CF Food | Azithromycin | 2.2 | Full Range 0.1 to 4.1 | mg/L |
| Other PK Measures: Median Time to Maximal Drug Concentration (Tmax) | Healthy Controls | Rifampin | 1.5 | Full Range 1 to 4 | hours |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention (1 Day) | STARTED | Healthy Controls (Fasting Only) | 10 | |
| First Intervention (1 Day) | STARTED | CF Patients, Fasting, Then Food | 11 | |
| First Intervention (1 Day) | STARTED | CF Patients, Food Then Fasting | 10 | |
| First Intervention (1 Day) | COMPLETED | Healthy Controls (Fasting Only) | 10 | |
| First Intervention (1 Day) | COMPLETED | CF Patients, Fasting, Then Food | 10 | |
| First Intervention (1 Day) | COMPLETED | CF Patients, Food Then Fasting | 10 | |
| First Intervention (1 Day) | NOT COMPLETED | Healthy Controls (Fasting Only) | 0 | |
| First Intervention (1 Day) | NOT COMPLETED | CF Patients, Fasting, Then Food | 1 | |
| First Intervention (1 Day) | NOT COMPLETED | CF Patients, Food Then Fasting | 0 | |
| Washout (14 Days) | STARTED | Healthy Controls (Fasting Only) | 10 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Healthy Controls | 0 | 10 |
| Total, all-cause mortality | CF Patients, Fasting | 0 | 21 |
| Total, all-cause mortality | CF Patients, Food | 0 | 20 |
| Total, other adverse events | Healthy Controls | 0 | 10 |
| Total, other adverse events | CF Patients, Fasting | 0 | 21 |
| Total, other adverse events | CF Patients, Food | 0 | 20 |
| Total, serious adverse events | Healthy Controls | 0 | 10 |
| Total, serious adverse events | CF Patients, Fasting | 0 | 21 |
| Total, serious adverse events | CF Patients, Food | 0 | 20 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34030986 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UL1TR001082 | Colorado Clinical and Translational Sciences Institute | SOKOL, RONALD J. | UNIVERSITY OF COLORADO DENVER | NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES | 2013 to 2017 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02372383
GET https://conductscience.org/api/trials/v1/NCT02372383/results?page=2