Trial · NCT01349192
Early Methicillin-resistant Staphylococcus Aureus (MRSA) Therapy in Cystic Fibrosis (CF)
NCT01349192, Phase 2, Terminated, University of North Carolina, Chapel Hill; results first posted 2017-05-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Early Methicillin-resistant Staphylococcus Aureus (MRSA) Therapy in Cystic Fibrosis (CF). Trials, record NCT01349192. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01349192
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Early Methicillin-resistant Staphylococcus Aureus (MRSA) Therapy in Cystic Fibrosis (CF)
- NCT number
- NCT01349192
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 47 participants, actual
- Lead sponsor
- University of North Carolina, Chapel Hill
- Conditions
- Cystic Fibrosis, Methicillin-resistant Staphylococcus Aureus
- Interventions
- Rifampin, Trimethoprim/Sulfamethoxazole, Minocycline, Mupirocin, chlorhexidine gluconate oral rinse, 2% Chlorhexidine solution wipes, Environmental Decontamination
- First posted
- 2011-05-06
- Last updated
- 2017-05-15
- Results first posted
- 2017-05-15
- Limitations and caveats
- The study was completed prior to reaching the pre-specified number of participants as the Data Safety Monitoring committee observed that efficacy had been reached.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | MRSA Culture Status | Day 28 | Proportion of subjects with a negative culture for MRSA at Day 28. |
| Secondary | Antibiotic Use (Proportion of Subjects) | 6 months | Proportion of subjects treated with oral, inhaled, and IV antibiotics over the 6 month study. |
| Secondary | Antibiotic Use (Days of Use Per Subject) | 6 months | Days of use of oral, inhaled, and IV antibiotics over the 6 month study. |
| Secondary | Pulmonary Exacerbations | 28 days | Proportion of subjects with a protocol-defined pulmonary exacerbation (PE) between baseline and day 28 who are treated with antibiotics active against MRSA. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | MRSA Culture Status | Day 28 | The analysis population is defined as all of the participants who were randomized to a study arm and were assessed for the primary microbiologic efficacy endpoint at both baseline and Day 28. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Antibiotic Use (Proportion of Subjects) | 6 months | Intention to treat | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Antibiotic Use (Days of Use Per Subject) | 6 months | Intention to treat | days | MEAN |
| SECONDARY | Pulmonary Exacerbations | 28 days | Intention to treat | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| MRSA Culture Status | Treatment | 18 | Participants | ||
| MRSA Culture Status | Observation | 5 | Participants | ||
| Antibiotic Use (Proportion of Subjects) | Treatment | 17 | Participants | ||
| Antibiotic Use (Proportion of Subjects) | Observation | 13 | Participants | ||
| Antibiotic Use (Days of Use Per Subject) | Treatment | 21.9 | Standard Deviation 23.7 | days | |
| Antibiotic Use (Days of Use Per Subject) | Observational | 31.3 | Standard Deviation 44.0 | days | |
| Pulmonary Exacerbations | Treatment | 2 | Participants | ||
| Pulmonary Exacerbations | Observation | 6 | Participants |
Source ClinicalTrials.gov
Participant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment | 24 | |
| Overall Study | STARTED | Observational | 23 | |
| Overall Study | Evaluable for Primary Endpoint | Treatment | 22 | |
| Overall Study | Evaluable for Primary Endpoint | Observational | 19 | |
| Overall Study | Withdrawals | Treatment | 3 | |
| Overall Study | Withdrawals | Observational | 6 | |
| Overall Study | COMPLETED | Treatment | 21 | |
| Overall Study | COMPLETED | Observational | 17 | |
| Overall Study | NOT COMPLETED | Treatment | 3 | |
| Overall Study | NOT COMPLETED | Observational | 6 |
Source ClinicalTrials.gov
Adverse events30
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Treatment | 4 | 24 | 4 |
| other | Diarrhoea | Gastrointestinal disorders | Observation | 0 | 21 | 0 |
| other | Nausea | Gastrointestinal disorders | Treatment | 6 | 24 | 7 |
| other | Nausea | Gastrointestinal disorders | Observation | 2 | 21 | 2 |
| other | Vomiting | Gastrointestinal disorders | Treatment | 5 | 24 | 8 |
| other | Vomiting | Gastrointestinal disorders | Observation | 1 | 21 | 1 |
| other | Pyrexia | General disorders | Treatment | 3 | 24 | 3 |
| other | Pyrexia | General disorders | Observation | 1 | 21 | 3 |
| other | Weight decreased | Investigations | Treatment | 0 | 24 | 0 |
| other | Weight decreased | Investigations | Observation | 2 | 21 | 2 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment | ||
| Total, all-cause mortality | Observation | ||
| Total, other adverse events | Treatment | 19 | 24 |
| Total, other adverse events | Observation | 13 | 21 |
| Total, serious adverse events | Treatment | 1 | 24 |
| Total, serious adverse events | Observation | 1 | 21 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Treatment vs Observation: Pulmonary Exacerbations | Trial comparisons |
| Treatment vs Observation: Antibiotic Use (Proportion of Subjects) | Trial comparisons |
| Treatment vs Observation: MRSA Culture Status | Trial comparisons |
| Treatment vs Observation: serious adverse events | Trial comparisons |
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/NCT01349192
GET https://conductscience.org/api/trials/v1/NCT01349192/events?page=2