Cystic FibrosisPhase 2PMEPNCT01594827
Persistent Methicillin Resistant Staphylococcus Aureus Eradication Protocol (PMEP)
A Phase 2 study testing Inhaled Vancomycin, Rifampin and Trimethoprim/Sulfamethoxazole (TMP/SMX) in people with Cystic Fibrosis, run by Johns Hopkins University at 2 sites in United States.
Trial summary
The prevalence of methicillin resistant Staphylococcus aureus (MRSA) respiratory infection in Cystic Fibrosis (CF) has increased dramatically over the last decade. Evidence suggests that persistent infection with MRSA may result in an increased rate of decline in Forced Expiratory Volume (FEV)1 and shortened survival. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Inhaled Vancomycin, Rifampin and Trimethoprim/Sulfamethoxazole (TMP/SMX)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2012to 30 Dec 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female ≥ 12 years of age.
- Confirmed diagnosis of CF based on the following criteria:
- positive sweat chloride > 60 mEq/liter (by pilocarpine iontophoresis) and/or a genotype with two identifiable mutations consistent with CF or abnormal Nasal Potential Difference (NPD), and one or more clinical features consistent with the CF phenotype.
- Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
- Two positive MRSA respiratory cultures in the last two years at least six months apart, plus a positive MRSA respiratory culture at Screening Visit and Run-in (Day -14) Visit.
- At least 50% of respiratory cultures from the time of the first MRSA culture (in the last two years) have been positive for MRSA.
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- Forced Expiratory Volume (FEV)1 > 40% of predicted normal for age, gender, and height at Screening, for subjects 18 years of age or older..
- FEV1> 60% of predicted normal for age, gender, and height at Screening, for subjects 12--17 years of old.
- Females of childbearing potential must agree to practice one highly effective method of birth control, including abstinence. Note: highly effective methods of birth control are those, alone or in combination, that result in a failure rate less than 1% per year when used consistently and correctly. Female patients who utilize hormonal contraceptives as a birth control method must have used the same method for at least 3 months before study dosing. If the patient is using a hormonal form of contraception, patients will be required to also use barrier contraceptives as rifampin can affect the reliability of hormone therapy. Barrier contraceptives such as male condom or diaphragm are acceptable if used in combination with spermicides
Who cannot join
- An acute upper or lower respiratory infection, pulmonary exacerbation, or change in routine therapy (including antibiotics) for pulmonary disease within 42 days of the Day 1 Visit (2 weeks prior to Screening visit).
- Individuals on chronic continuous inhaled antibiotics without interruption who are not willing to substitute vancomycin or placebo for their scheduled inhaled antibiotic during days 0-28 of the study (every other month inhaled antibiotics are acceptable)
- Use of oral or inhaled anti-MRSA drugs within two weeks of the Screening Visit.
- History of intolerance to inhaled vancomycin or inhaled albuterol.
- History of intolerance to rifampin or both TMP/SMX and doxycycline.
- Resistance to rifampin or both TMP/SMX and doxycycline at Screening.
Show all 19Show fewer
- Resistance to vancomycin at Screening.
- Abnormal renal function, defined as creatinine clearance < 50 mL/min using the Cockcroft-Gault equation for adults or Schwartz equation in children, at Screening.
- Abnormal liver function, defined as ≥ 3x upper limit of normal (ULN), of serum aspartate transaminase (AST) or serum alanine transaminase (ALT), or known cirrhosis. at the time of Screening.
- Serum hematology or chemistry results which in the judgment of the investigator would interfere with completion of the study.
- History of or listed for solid organ or hematological transplantation
- History of sputum culture with non-tuberculous Mycobacteria in the last 6 months.
- History of sputum culture with Burkholderia Cepacia in the last year.
- Planned continuous use of soft contact lenses while taking rifampin and no access to glasses.
- Current use of oral corticosteroids in doses exceeding the equivalent of 10 mg prednisone a day or 20 mg prednisone every other day
- Administration of any investigational drug or device within 28 days of Screening or within 6 half-lives of the investigational drug (whichever is longer).
- Patients on inhaled antibiotics must have been on the same regimen for the 4 months prior to screening
- Female patients of childbearing potential who are pregnant or lactating, or plan on becoming pregnant
- Any serious or active medical or psychiatric illness, which in the opinion of the investigator, would interfere with patient treatment, assessment, or adherence to the protocol.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205
Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106
About this study
Official title: Persistent MRSA Eradication Protocol (PMEP)
The prevalence of methicillin resistant Staphylococcus aureus (MRSA) respiratory infection in Cystic Fibrosis (CF) has increased dramatically over the last decade. Evidence suggests that persistent infection with MRSA may result in an increased rate of decline in Forced Expiratory Volume (FEV)1 and shortened survival. Currently there are no conclusive studies demonstrating an effective aggressive treatment protocol for persistent MRSA respiratory infection in CF. Data demonstrating an effective and safe method of clearing persistent MRSA infection are needed.
The purpose of this study is to evaluate the safety and efficacy of a 28-day course of vancomycin for inhalation, 250 mg twice a day, (in combination with oral antibiotics) in eliminating MRSA from the respiratory tract of individuals with CF and persistent MRSA infection. Subjects will be assigned in a 1:1 ratio to either vancomycin for inhalation (250 mg twice a day) or taste matched placebo and will be followed for 3 additional months. In addition, both groups will receive oral rifampin, a second oral antibiotic (TMP-SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Forty patients with persistent respiratory tract MRSA infection will be enrolled in this trial.
Read the detailed description
Primary Objectives
The primary objectives of this trial are to:
- Determine the efficacy of an aggressive treatment protocol in eradicating persistent MRSA infection in individuals with CF.
- Determine the safety of an aggressive treatment protocol in eradicating persistent MRSA infection in individuals with CF.
Secondary Objectives
The secondary objectives of this trial are to:
- Determine the efficacy of an aggressive treatment protocol in improving Forced Expiratory Volume (FEV)1, time to exacerbation, and quality of life in individuals with CF and persistent MRSA infection.
- Determine if there is benefit to adding nebulized vancomycin to an aggressive oral antibiotic treatment protocol in eradicating persistent MRSA infection in individuals with CF.
- Conditions
- Cystic Fibrosis
- Being tested
- Inhaled Vancomycin, Placebo (Sterile Water), Rifampin, Trimethoprim/Sulfamethoxazole (TMP/SMX), Doxycycline
- Keywords
- Methicillin-resistant Staphylococcus aureus, Vancomycin
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled VancomycinDrug
Also called Vanc
On Days 1-28, subjects will receive nebulized Vancomycin. This will be supplied as a 250 mg solution to be nebulized two times a day for 28 days in 5cc sterile water. Patients will use a Pari Sprint nebulizer and Pari Vios compressor as the delivery system.
Placebo (Sterile Water)Drug
Also called Placebo
On Days 1-28, subjects will receive 5cc of a nebulized Placebo (Sterile water) twice a day. This is a taste (quinine 0.1mg/mL) matched nebulized placebo (sterile water). Patients will use a Pari Sprint nebulizer and Pari Vios compressor as the delivery system.
RifampinDrug
Also called Rifadin
Oral Rifampin by mouth for 28 days
- >45 kg: 600 mg by mouth daily
- 35-45 kg : 450 mg by mouth daily
- 25-34.9 kg: 300 mg by mouth daily
Trimethoprim/Sulfamethoxazole (TMP/SMX)Drug
Also called Bactrim, Septra
Oral trimethoprim/sulfamethoxazole (DS-160/800)
- >45 kg: two DS tablets twice a day by mouth (320/1600)
- 25-45 kg: one DS tablet twice a day by mouth (160/800)
DoxycyclineDrug
Also called Vibramycin, Adoxa
If sulfa intolerant or TMP/SMX Resistant, use instead oral doxycycline
- >45 kg: 100 mg by mouth twice a day
- 35-45 kg : 75 mg by mouth twice a day iii. 25-34.9 kg: 50 mg by mouth twice a day
Mupirocin Intranasal CremeDrug
Also called Bactroban
Mupirocin 2% intranasal creme: half of single use tube applied into each nostril twice a day for 5 days.
4% chlorhexidine gluconate liquid skin cleanserDrug
Also called Hibiclens
Hibiclens 15cc liquid skin cleanser packets (4% chlorhexidine gluconate): use three packets once weekly for four weeks in the shower from the neck to toes, with attention on the axilla, groin, and buttocks.
| Study group | Role | What they receive |
|---|---|---|
| Inhaled Vanc and Oral Abx | Experimental | 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. Receives: Drug: Inhaled Vancomycin; Drug: Rifampin; Drug: Trimethoprim/Sulfamethoxazole (TMP/SMX); Drug: Doxycycline; Drug: Mupirocin Intranasal Creme; Drug: 4% chlorhexidine gluconate liquid skin cleanser |
| Inhaled Placebo and Oral Abx | Active comparator | 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. Receives: Drug: Placebo (Sterile Water); Drug: Rifampin; Drug: Trimethoprim/Sulfamethoxazole (TMP/SMX); Drug: Doxycycline; Drug: Mupirocin Intranasal Creme; Drug: 4% chlorhexidine gluconate liquid skin cleanser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 58 (Visit 5), approximately 1 month after completion of the MRSA treatment protocol
Secondary outcomes (8)
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
Measured: Day 29
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
Measured: Baseline, Day 58
Time to First CF Exacerbation
Time to First CF Exacerbation using a standardized exacerbation definition from Day 1 to Day 118
Measured: Day 1 to Day 118
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
Measured: Days 58 and 118
Change if FEV1% Predicted From Screening
Change in FEV1% predicted from Screening at Days 29, 58, and 118 in treatment vs. standard care group
Measured: Days 29, 58, and 118
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.
Measured: Days 29 and 58
Development of Antibiotic Resistance
Number of patients with newly developed MRSA resistance to vancomycin, TMP/SMX, doxycycline, or rifampin.
Measured: Day 58 (Visit 5)
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
Measured: Completion of Study Drug to Day 118
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2012 (estimated)
- Study startOct 2012
- Primary completion30 Dec 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Case Western Reserve University, Cystic Fibrosis Foundation
- Responsible party
- Sponsor
- Investigators
- Michael P Boyle, MD, Principal investigator, Johns Hopkins School of MedicineJames Chmiel, MD, Principal investigator, Case Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01594827
- Sponsor's protocol ID
- NA_00017536
- Acronym
- PMEP
- Status last verified
- Feb 2019
- First submitted
- 7 May 2012
- Last updated
- 26 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Dasenbrook EC, Checkley W, Merlo CA, Konstan MW, Lechtzin N, Boyle MP. Association between respiratory tract methicillin-resistant Staphylococcus aureus and survival in cystic fibrosis. JAMA. 2010 Jun 16;303(23):2386-92. doi: 10.1001/jama.2010.791.
PubMed 20551409Dasenbrook EC, Merlo CA, Diener-West M, Lechtzin N, Boyle MP. Persistent methicillin-resistant Staphylococcus aureus and rate of FEV1 decline in cystic fibrosis. Am J Respir Crit Care Med. 2008 Oct 15;178(8):814-21. doi: 10.1164/rccm.200802-327OC. Epub 2008 Jul 31.
PubMed 18669817Jennings MT, Boyle MP, Weaver D, Callahan KA, Dasenbrook EC. Eradication strategy for persistent methicillin-resistant Staphylococcus aureus infection in individuals with cystic fibrosis--the PMEP trial: study protocol for a randomized controlled trial. Trials. 2014 Jun 12;15:223. doi: 10.1186/1745-6215-15-223.
PubMed 24925006Lo DK, Muhlebach MS, Smyth AR. Interventions for the eradication of meticillin-resistant Staphylococcus aureus (MRSA) in people with cystic fibrosis. Cochrane Database Syst Rev. 2022 Dec 13;12(12):CD009650. doi: 10.1002/14651858.CD009650.pub5.
PubMed 36511181
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistent MRSA Eradication Protocol (PMEP)
- ClinicalTrials.gov ID
- NCT01594827
- Acronym / sponsor ID
- PMEP / NA_00017536
- Conditions
- Cystic Fibrosis
- Keywords
- Methicillin-resistant Staphylococcus aureus, Vancomycin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Case Western Reserve University, Cystic Fibrosis Foundation
- Study start
- Oct 2012 (actual)
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 9 May 2012 (estimated)
- Results
- Posted 20 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The prevalence of methicillin resistant Staphylococcus aureus (MRSA) respiratory infection in Cystic Fibrosis (CF) has increased dramatically over the last decade. Evidence suggests that persistent infection with MRSA may result in an increased rate of decline in Forced Expiratory Volume (FEV)1 and shortened survival. Currently there are no conclusive studies demonstrating an effective aggressive treatment protocol for persistent MRSA respiratory infection in CF. Data demonstrating an effective and safe method of clearing persistent MRSA infection are needed.
The purpose of this study is to evaluate the safety and efficacy of a 28-day course of vancomycin for inhalation, 250 mg twice a day, (in combination with oral antibiotics) in eliminating MRSA from the respiratory tract of individuals with CF and persistent MRSA infection. Subjects will be assigned in a 1:1 ratio to either vancomycin for inhalation (250 mg twice a day) or taste matched placebo and will be followed for 3 additional months. In addition, both groups will receive oral rifampin, a second oral antibiotic (TMP-SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Forty patients with persistent respiratory tract MRSA infection will be enrolled in this trial.
Detailed description
Primary Objectives
The primary objectives of this trial are to:
- Determine the efficacy of an aggressive treatment protocol in eradicating persistent MRSA infection in individuals with CF.
- Determine the safety of an aggressive treatment protocol in eradicating persistent MRSA infection in individuals with CF.
Secondary Objectives
The secondary objectives of this trial are to:
- Determine the efficacy of an aggressive treatment protocol in improving Forced Expiratory Volume (FEV)1, time to exacerbation, and quality of life in individuals with CF and persistent MRSA infection.
- Determine if there is benefit to adding nebulized vancomycin to an aggressive oral antibiotic treatment protocol in eradicating persistent MRSA infection in individuals with CF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhaled Vanc and Oral Abx | Experimental | Drug: Inhaled Vancomycin, Drug: Rifampin, Drug: Trimethoprim/Sulfamethoxazole (TMP/SMX), Drug: Doxycycline, Drug: Mupirocin Intranasal Creme, Drug: 4% chlorhexidine gluconate liquid skin cleanserIn 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. |
| Inhaled Placebo and Oral Abx | Active comparator | Drug: Placebo (Sterile Water), Drug: Rifampin, Drug: Trimethoprim/Sulfamethoxazole (TMP/SMX), Drug: Doxycycline, Drug: Mupirocin Intranasal Creme, Drug: 4% chlorhexidine gluconate liquid skin cleanserIn 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female ≥ 12 years of age.
- Confirmed diagnosis of CF based on the following criteria:
- positive sweat chloride > 60 mEq/liter (by pilocarpine iontophoresis) and/or a genotype with two identifiable mutations consistent with CF or abnormal Nasal Potential Difference (NPD), and one or more clinical features consistent with the CF phenotype.
- Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
- Two positive MRSA respiratory cultures in the last two years at least six months apart, plus a positive MRSA respiratory culture at Screening Visit and Run-in (Day -14) Visit.
Key exclusion criteria (19 listed)
- An acute upper or lower respiratory infection, pulmonary exacerbation, or change in routine therapy (including antibiotics) for pulmonary disease within 42 days of the Day 1 Visit (2 weeks prior to Screening visit).
- Individuals on chronic continuous inhaled antibiotics without interruption who are not willing to substitute vancomycin or placebo for their scheduled inhaled antibiotic during days 0-28 of the study (every other month inhaled antibiotics are acceptable)
- Use of oral or inhaled anti-MRSA drugs within two weeks of the Screening Visit.
- History of intolerance to inhaled vancomycin or inhaled albuterol.
- History of intolerance to rifampin or both TMP/SMX and doxycycline.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhaled VancomycinAlso: VancOn Days 1-28, subjects will receive nebulized Vancomycin. This will be supplied as a 250 mg solution to be nebulized two times a day for 28 days in 5cc sterile water. Patients will use a Pari Sprint nebulizer and Pari Vios compressor as the delivery system. | Drug | Inhaled Vanc and Oral Abx |
| Placebo (Sterile Water)Also: PlaceboOn Days 1-28, subjects will receive 5cc of a nebulized Placebo (Sterile water) twice a day. This is a taste (quinine 0.1mg/mL) matched nebulized placebo (sterile water). Patients will use a Pari Sprint nebulizer and Pari Vios compressor as the delivery system. | Drug | Inhaled Placebo and Oral Abx |
| RifampinAlso: RifadinOral Rifampin by mouth for 28 days 1. >45 kg: 600 mg by mouth daily 2. 35-45 kg : 450 mg by mouth daily 3. 25-34.9 kg: 300 mg by mouth daily | Drug | Inhaled Placebo and Oral Abx, Inhaled Vanc and Oral Abx |
| Trimethoprim/Sulfamethoxazole (TMP/SMX)Also: Bactrim, SeptraOral trimethoprim/sulfamethoxazole (DS-160/800) 1. >45 kg: two DS tablets twice a day by mouth (320/1600) 2. 25-45 kg: one DS tablet twice a day by mouth (160/800) | Drug | Inhaled Placebo and Oral Abx, Inhaled Vanc and Oral Abx |
| DoxycyclineAlso: Vibramycin, AdoxaIf sulfa intolerant or TMP/SMX Resistant, use instead oral doxycycline 1. >45 kg: 100 mg by mouth twice a day 2. 35-45 kg : 75 mg by mouth twice a day iii. 25-34.9 kg: 50 mg by mouth twice a day | Drug | Inhaled Placebo and Oral Abx, Inhaled Vanc and Oral Abx |
| Mupirocin Intranasal CremeAlso: BactrobanMupirocin 2% intranasal creme: half of single use tube applied into each nostril twice a day for 5 days. | Drug | Inhaled Placebo and Oral Abx, Inhaled Vanc and Oral Abx |
| 4% chlorhexidine gluconate liquid skin cleanserAlso: HibiclensHibiclens 15cc liquid skin cleanser packets (4% chlorhexidine gluconate): use three packets once weekly for four weeks in the shower from the neck to toes, with attention on the axilla, groin, and buttocks. | Drug | Inhaled Placebo and Oral Abx, Inhaled Vanc and Oral Abx |
Primary outcome
Number of Patients MRSA Free by Induced Sputum Respiratory Tract Culture
Time frame: 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.
8 secondary outcomes
Percentage of Patients MRSA Free by Induced Sputum Respiratory Tract Culture
Time frame: Day 29
Change in Forced Expiratory Volume (FEV1)% Predicted From Baseline to Day 58
Time frame: Baseline, Day 58
Time to First CF Exacerbation
Time frame: Day 1 to Day 118
Total Number of Pulmonary Exacerbations
Time frame: Days 58 and 118
Change if FEV1% Predicted From Screening
Time frame: Days 29, 58, and 118
Change in Patient Reported Quality of Life (CFQ-R)(Respiratory)
Time frame: Days 29 and 58
Development of Antibiotic Resistance
Time frame: Day 58 (Visit 5)
Time to First Anti-MRSA Antibiotics (After Treatment Period)
Time frame: Completion of Study Drug to Day 118
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20551409Dasenbrook EC, Checkley W, Merlo CA, Konstan MW, Lechtzin N, Boyle MP. Association between respiratory tract methicillin-resistant Staphylococcus aureus and survival in cystic fibrosis. JAMA. 2010 Jun 16;303(23):2386-92. doi: 10.1001/jama.2010.791.
- Background: PubMed 18669817Dasenbrook EC, Merlo CA, Diener-West M, Lechtzin N, Boyle MP. Persistent methicillin-resistant Staphylococcus aureus and rate of FEV1 decline in cystic fibrosis. Am J Respir Crit Care Med. 2008 Oct 15;178(8):814-21. doi: 10.1164/rccm.200802-327OC. Epub 2008 Jul 31.
- Background: PubMed 24925006Jennings MT, Boyle MP, Weaver D, Callahan KA, Dasenbrook EC. Eradication strategy for persistent methicillin-resistant Staphylococcus aureus infection in individuals with cystic fibrosis--the PMEP trial: study protocol for a randomized controlled trial. Trials. 2014 Jun 12;15:223. doi: 10.1186/1745-6215-15-223.
- Derived from this study: PubMed 36511181Lo DK, Muhlebach MS, Smyth AR. Interventions for the eradication of meticillin-resistant Staphylococcus aureus (MRSA) in people with cystic fibrosis. Cochrane Database Syst Rev. 2022 Dec 13;12(12):CD009650. doi: 10.1002/14651858.CD009650.pub5.
- Cystic Fibrosis Foundation websiteLink provided by the sponsor.
- Johns Hopkins Cystic Fibrosis Center websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael P Boyle, MD principal investigator
Johns Hopkins School of Medicine
James Chmiel, MD principal investigator
Case Western University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Inhaled Vancomycin, Rifampin and Trimethoprim/Sulfamethoxazole (TMP/SMX) in people with Cystic Fibrosis, run by Johns Hopkins University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients MRSA Free by Induced Sputum Respiratory Tract Culture (time frame: Day 58 (Visit 5), approximately 1 month after completion of the MRSA treatment protocol). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01594827, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.