| Primary | Number of Patients MRSA Free by Induced Sputum Respiratory Tract Culture | 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. | | Posted | | Count of Participants | | Participants | | Day 58 (Visit 5), approximately 1 month after completion of the MRSA treatment protocol | | | | ID | Title | Description |
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| OG000 | Inhaled Vancomycin and Oral Antibiotics | In the experimental arm CF participants are randomized to 28 days of inhaled sterile vancomycin (250 mg twice a day) as well as 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients will be followed for 3 months after completion of the treatment protocol. | | OG001 | Inhaled Placebo (Sterile Water) and Oral Antibiotics | In the active comparator arm CF participants are randomized to 28 days of inhaled sterile placebo (saline) and are treated with 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients will be followed for 3 months after completion of the treatment protocol. |
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| Secondary | Percentage of Patients MRSA Free by Induced Sputum Respiratory Tract Culture | 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 | | Posted | | Count of Participants | | Participants | | Day 29 | | | | ID | Title | Description |
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| OG000 | Inhaled Vancomycin and Oral Antibiotics | In the experimental arm CF participants are randomized to 28 days of inhaled sterile vancomycin (250 mg twice a day) as well as 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients will be followed for 3 months after completion of the treatment protocol. | | OG001 | Inhaled Placebo (Sterile Water) and Oral Antibiotics | In the active comparator arm CF participants are randomized to 28 days of inhaled sterile placebo (saline) and are treated with 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients will be followed for 3 months after completion of the treatment protocol. |
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| Secondary | Change in Forced Expiratory Volume (FEV1)% Predicted From Baseline to Day 58 | Change in Forced Expiratory Volume (FEV1)% predicted from baseline to day number 58 | | Posted | | Median | Inter-Quartile Range | % predicted FEV1 | | Baseline, Day 58 | | | | ID | Title | Description |
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| OG000 | Inhaled Vancomycin and Oral Antibiotics | In the experimental arm CF participants are randomized to 28 days of inhaled sterile vancomycin (250 mg twice a day) as well as 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients will be followed for 3 months after completion of the treatment protocol. | | OG001 | Inhaled Placebo (Sterile Water) and Oral Antibiotics | In the active comparator arm CF participants are randomized to 28 days of inhaled sterile placebo (saline) and are treated with 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients will be followed for 3 months after completion of the treatment protocol. |
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| Secondary | Time to First CF Exacerbation | Time to First CF Exacerbation using a standardized exacerbation definition from Day 1 to Day 118 | | Posted | | Mean | Standard Deviation | Days | | Day 1 to Day 118 | | | | ID | Title | Description |
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| OG000 | Inhaled Vancomycin and Oral Antibiotics | In the experimental arm CF participants were randomized to 28 days of inhaled sterile vancomycin (250 mg twice a day) as well as 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients were followed for 3 months after completion of the treatment protocol. | | OG001 | Inhaled Placebo (Sterile Water) and Oral Antibiotics | In the active comparator arm CF participants were randomized to 28 days of inhaled sterile placebo (saline) and treated with 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients were followed for 3 months after completion of the treatment protocol. |
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| Secondary | Total Number of Pulmonary Exacerbations | Total Number of Pulmonary Exacerbations using a standardized exacerbation definition at Days 58 and Days 118 in treatment vs. standard care group | | Posted | | Number | | Exacerbations | | Days 58 and 118 | | | | ID | Title | Description |
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| OG000 | Inhaled Vancomycin and Oral Antibiotics | In the experimental arm CF participants were randomized to 28 days of inhaled sterile vancomycin (250 mg twice a day) as well as 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients were followed for 3 months after completion of the treatment protocol. | | OG001 | Inhaled Placebo (Sterile Water) and Oral Antibiotics | In the active comparator arm CF participants were randomized to 28 days of inhaled sterile placebo (saline) and treated with 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients were followed for 3 months after completion of the treatment protocol. |
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| Secondary | Change if FEV1% Predicted From Screening | Change in FEV1% predicted from Screening at Days 29, 58, and 118 in treatment vs. standard care group | | Posted | | Mean | Standard Error | FEV1% predicted | | Days 29, 58, and 118 | | | | ID | Title | Description |
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| OG000 | Inhaled Vancomycin and Oral Antibiotics | In the experimental arm CF participants were randomized to 28 days of inhaled sterile vancomycin (250 mg twice a day) as well as 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients were followed for 3 months after completion of the treatment protocol. | | OG001 | Inhaled Placebo (Sterile Water) and Oral Antibiotics | In the active comparator arm CF participants were randomized to 28 days of inhaled sterile placebo (saline) and treated with 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients were followed for 3 months after completion of the treatment protocol. |
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| Secondary | Change in Patient Reported Quality of Life (CFQ-R)(Respiratory) | 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. | | Posted | | Mean | Standard Error | units on a scale | | Days 29 and 58 | | | | ID | Title | Description |
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| OG000 | Inhaled Vancomycin and Oral Antibiotics | In the experimental arm CF participants were randomized to 28 days of inhaled sterile vancomycin (250 mg twice a day) as well as 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients were followed for 3 months after completion of the treatment protocol. | | OG001 | Inhaled Placebo (Sterile Water) and Oral Antibiotics | In the active comparator arm CF participants were randomized to 28 days of inhaled sterile placebo (saline) and treated with 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients were followed for 3 months after completion of the treatment protocol. |
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| Secondary | Development of Antibiotic Resistance | Number of patients with newly developed MRSA resistance to vancomycin, TMP/SMX, doxycycline, or rifampin. | No resistance to doxycycline or TMP/SMX. All developed resistance was to rifampin. | Posted | | Count of Participants | | Participants | | Day 58 (Visit 5) | | | | ID | Title | Description |
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| OG000 | Inhaled Vancomycin and Oral Antibiotics | In the experimental arm CF participants were randomized to 28 days of inhaled sterile vancomycin (250 mg twice a day) as well as 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients were followed for 3 months after completion of the treatment protocol. | | OG001 | Inhaled Placebo (Sterile Water) and Oral Antibiotics | In the active comparator arm CF participants were randomized to 28 days of inhaled sterile placebo (saline) and treated with 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients were followed for 3 months after completion of the treatment protocol. |
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| Secondary | Time to First Anti-MRSA Antibiotics (After Treatment Period) | Time between completion of Study Drug and need for anti-MRSA antibiotics to control or treat symptoms | | Posted | | Mean | Standard Deviation | days | | Completion of Study Drug to Day 118 | | | | ID | Title | Description |
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| OG000 | Inhaled Vancomycin and Oral Antibiotics | In the experimental arm CF participants were randomized to 28 days of inhaled sterile vancomycin (250 mg twice a day) as well as 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients were followed for 3 months after completion of the treatment protocol. | | OG001 | Inhaled Placebo (Sterile Water) and Oral Antibiotics | In the active comparator arm CF participants were randomized to 28 days of inhaled sterile placebo (saline) and treated with 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients were followed for 3 months after completion of the treatment protocol. |
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