Trial · NCT01594827
Persistent Methicillin Resistant Staphylococcus Aureus Eradication Protocol (PMEP)
NCT01594827, Phase 2, Completed, Johns Hopkins University; results first posted 2018-11-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Persistent Methicillin Resistant Staphylococcus Aureus Eradication Protocol (PMEP). Trials, record NCT01594827. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01594827
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Persistent Methicillin Resistant Staphylococcus Aureus Eradication Protocol (PMEP)
- NCT number
- NCT01594827
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 29 participants, actual
- Lead sponsor
- Johns Hopkins University
- Conditions
- Cystic Fibrosis
- Interventions
- Inhaled Vancomycin, Placebo (Sterile Water), Rifampin, Trimethoprim/Sulfamethoxazole (TMP/SMX), Doxycycline, Mupirocin Intranasal Creme, 4% chlorhexidine gluconate liquid skin cleanser
- First posted
- 2012-05-09
- Last updated
- 2019-02-26
- Results first posted
- 2018-11-20
- Limitations and caveats
- Easy termination leading to smaller number of subjects analyzed.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients MRSA Free by Induced Sputum Respiratory Tract Culture | Day 58 (Visit 5), approximately 1 month after completion of the MRSA treatment protocol | The hypothesis for our primary outcome is that the aggressive treatment arm will result in significantly greater eradication of persistent MRSA from the respiratory tract of CF adolescents and adults on day 58 (1 month after completion of therapy) compared to the placebo/standard treatment arm. Our primary outcome will be comparing the proportion of CF patients in the treatment arm who have a negative induced sputum MRSA culture at Day 58 to the proportion of patients in the placebo arm who have a negative induced sputum MRSA culture at Day 58. |
| Secondary | Percentage of Patients MRSA Free by Induced Sputum Respiratory Tract Culture | Day 29 | Percentage of patients MRSA free by induced sputum respiratory tract culture one day after completion of four-week eradication protocol (Day 29) in intervention arm vs standard treatment arm |
| Secondary | Change in Forced Expiratory Volume (FEV1)% Predicted From Baseline to Day 58 | Baseline, Day 58 | Change in Forced Expiratory Volume (FEV1)% predicted from baseline to day number 58 |
| Secondary | Time to First CF Exacerbation | Day 1 to Day 118 | Time to First CF Exacerbation using a standardized exacerbation definition from Day 1 to Day 118 |
| Secondary | Total Number of Pulmonary Exacerbations | Days 58 and 118 | Total Number of Pulmonary Exacerbations using a standardized exacerbation definition at Days 58 and Days 118 in treatment vs. standard care group |
| Secondary | Change if FEV1% Predicted From Screening | Days 29, 58, and 118 | Change in FEV1% predicted from Screening at Days 29, 58, and 118 in treatment vs. standard care group |
| Secondary | Change in Patient Reported Quality of Life (CFQ-R)(Respiratory) | Days 29 and 58 | Change in Patient Reported Quality of Life (CFQ-R)(respiratory) from baseline to Days 29 and 58. CFQ-R stands for Cystic Fibrosis Quality of Life Measure, Respiratory Domain. Overall range of absolute score 0 to +80. Higher score means better quality of life. Positive change in score means improvement in quality of life. Minimally clinically significant difference: +/- 4.0 units. |
| Secondary | Development of Antibiotic Resistance | Day 58 (Visit 5) | Number of patients with newly developed MRSA resistance to vancomycin, TMP/SMX, doxycycline, or rifampin. |
| Secondary | Time to First Anti-MRSA Antibiotics (After Treatment Period) | Completion of Study Drug to Day 118 | Time between completion of Study Drug and need for anti-MRSA antibiotics to control or treat symptoms |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients MRSA Free by Induced Sputum Respiratory Tract Culture | Day 58 (Visit 5), approximately 1 month after completion of the MRSA treatment protocol | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage of Patients MRSA Free by Induced Sputum Respiratory Tract Culture | Day 29 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change in Forced Expiratory Volume (FEV1)% Predicted From Baseline to Day 58 | Baseline, Day 58 | % predicted FEV1 | MEDIAN | |
| SECONDARY | Time to First CF Exacerbation | Day 1 to Day 118 | Days | MEAN | |
| SECONDARY | Total Number of Pulmonary Exacerbations | Days 58 and 118 | Exacerbations | NUMBER | |
| SECONDARY | Change if FEV1% Predicted From Screening | Days 29, 58, and 118 | FEV1% predicted | MEAN | |
| SECONDARY | Change in Patient Reported Quality of Life (CFQ-R)(Respiratory) | Days 29 and 58 | units on a scale | MEAN | |
| SECONDARY | Development of Antibiotic Resistance | Day 58 (Visit 5) | No resistance to doxycycline or TMP/SMX. All developed resistance was to rifampin. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to First Anti-MRSA Antibiotics (After Treatment Period) | Completion of Study Drug to Day 118 | days | MEAN |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients MRSA Free by Induced Sputum Respiratory Tract Culture | Inhaled Vancomycin and Oral Antibiotics | 2 | Participants | ||
| Number of Patients MRSA Free by Induced Sputum Respiratory Tract Culture | Inhaled Placebo (Sterile Water) and Oral Antibiotics | 3 | Participants | ||
| Percentage of Patients MRSA Free by Induced Sputum Respiratory Tract Culture | Inhaled Vancomycin and Oral Antibiotics | 5 | Participants | ||
| Percentage of Patients MRSA Free by Induced Sputum Respiratory Tract Culture | Inhaled Placebo (Sterile Water) and Oral Antibiotics | 6 | Participants | ||
| Change in Forced Expiratory Volume (FEV1)% Predicted From Baseline to Day 58 | Inhaled Vancomycin and Oral Antibiotics | -2.5 | Inter-Quartile Range -6.0 to 1.0 | % predicted FEV1 | |
| Change in Forced Expiratory Volume (FEV1)% Predicted From Baseline to Day 58 | Inhaled Placebo (Sterile Water) and Oral Antibiotics | 1.0 | Inter-Quartile Range -5.0 to 6.0 | % predicted FEV1 | |
| Time to First CF Exacerbation | Inhaled Vancomycin and Oral Antibiotics | NA | Standard Deviation NA | Days | |
| Time to First CF Exacerbation | Inhaled Placebo (Sterile Water) and Oral Antibiotics | 68.4 | Standard Deviation 22.2 | Days | |
| Total Number of Pulmonary Exacerbations | Inhaled Vancomycin and Oral Antibiotics | Day 58 | 0 | Exacerbations | |
| Total Number of Pulmonary Exacerbations | Inhaled Placebo (Sterile Water) and Oral Antibiotics | Day 58 | 1 | Exacerbations |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Inhaled Vancomycin and Oral Antibiotics | 14 | |
| Overall Study | STARTED | Inhaled Placebo (Sterile Water) and Oral Antibiotics | 15 | |
| Overall Study | COMPLETED | Inhaled Vancomycin and Oral Antibiotics | 10 | |
| Overall Study | COMPLETED | Inhaled Placebo (Sterile Water) and Oral Antibiotics | 15 | |
| Overall Study | NOT COMPLETED | Inhaled Vancomycin and Oral Antibiotics | 4 | |
| Overall Study | NOT COMPLETED | Inhaled Placebo (Sterile Water) and Oral Antibiotics | 0 |
Source ClinicalTrials.gov
Adverse events32
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 | Cough | Respiratory, thoracic and mediastinal disorders | Inhaled Vancomycin and Oral Antibiotics | 8 | 14 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Inhaled Placebo (Sterile Water) and Oral Antibiotics | 3 | 15 | |
| other | Nasal Congestion | Respiratory, thoracic and mediastinal disorders | Inhaled Vancomycin and Oral Antibiotics | 4 | 14 | |
| other | Nasal Congestion | Respiratory, thoracic and mediastinal disorders | Inhaled Placebo (Sterile Water) and Oral Antibiotics | 6 | 15 | |
| other | Diarrhea | Gastrointestinal disorders | Inhaled Vancomycin and Oral Antibiotics | 7 | 14 | |
| other | Diarrhea | Gastrointestinal disorders | Inhaled Placebo (Sterile Water) and Oral Antibiotics | 2 | 15 | |
| other | Throat Symptoms | Respiratory, thoracic and mediastinal disorders | Inhaled Vancomycin and Oral Antibiotics | 5 | 14 | |
| other | Throat Symptoms | Respiratory, thoracic and mediastinal disorders | Inhaled Placebo (Sterile Water) and Oral Antibiotics | 3 | 15 | |
| other | Chest Tightness | Respiratory, thoracic and mediastinal disorders | Inhaled Vancomycin and Oral Antibiotics | 4 | 14 | |
| other | Chest Tightness | Respiratory, thoracic and mediastinal disorders | Inhaled Placebo (Sterile Water) and Oral Antibiotics | 4 | 15 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Inhaled Vancomycin and Oral Antibiotics | 0 | 14 |
| Total, all-cause mortality | Inhaled Placebo (Sterile Water) and Oral Antibiotics | 0 | 15 |
| Total, other adverse events | Inhaled Vancomycin and Oral Antibiotics | 14 | 14 |
| Total, other adverse events | Inhaled Placebo (Sterile Water) and Oral Antibiotics | 14 | 15 |
| Total, serious adverse events | Inhaled Vancomycin and Oral Antibiotics | 1 | 14 |
| Total, serious adverse events | Inhaled Placebo (Sterile Water) and Oral Antibiotics | 3 | 15 |
Source ClinicalTrials.gov
Papers4
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Inhaled Vancomycin and Oral Antibiotics vs Inhaled Placebo (Sterile Water) and Oral Antibiotics: Percentage of Patients MRSA Free by Induced Sputum Respiratory Tract Culture | Trial comparisons |
| Inhaled Vancomycin and Oral Antibiotics vs Inhaled Placebo (Sterile Water) and Oral Antibiotics: Development of Antibiotic Resistance | Trial comparisons |
| Inhaled Vancomycin and Oral Antibiotics vs Inhaled Placebo (Sterile Water) and Oral Antibiotics: Number of Patients MRSA Free by Induced Sputum Respiratory Tract Culture | Trial comparisons |
| Inhaled Vancomycin and Oral Antibiotics vs Inhaled Placebo (Sterile Water) and Oral Antibiotics: deaths from any cause | Trial comparisons |
| Inhaled Vancomycin and Oral Antibiotics vs Inhaled Placebo (Sterile Water) and Oral Antibiotics: 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/NCT01594827
GET https://conductscience.org/api/trials/v1/NCT01594827/results?page=2