Epidemiology and Treatment of Small-colony Variant Staphylococcus Aureus in Cystic Fibrosis
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|ClinicalTrials.gov Identifier: NCT02547116|
Recruitment Status : Suspended (Administrative delay)
First Posted : September 11, 2015
Last Update Posted : January 14, 2020
Methicillin-susceptible (MSSA) and Methicillin-resistant (MRSA) Staphylococcus aureus (SA) are two of the most important infectious pathogens in CF, with 69% of CF patients having lung infection with MSSA or MRSA in the last year. Wolter and co-workers recently demonstrated that a specific morphologic subtype of MSSA and MRSA, small-colony variant Staph aureus (SCV-SA), is associated with greater decline in lung function and worse clinical outcomes. SCV-SA is already recognized for its ability to contribute to persistent infection, likely due to SCV-SA's ability for intracellular growth, as well as its increased antibiotic resistance compared to normal-colony SA. To investigate the epidemiology and clinical significance of SCV-SA in CF, and explore the hypothesis that SCV-SA may require unique antibiotic treatment strategies to optimize clinical response, the investigators will perform the following:
- Characterize the epidemiology of SCV-SA infection in both an adult and pediatric CF population and investigate the clinical significance of SCV-SA infection in CF by comparing clinical characteristics and outcomes of CF patients with SCV-SA compared to those with to normal-colony MSSA/MRSA.
- Characterize the unique microbiologic characteristics of SCV-SA infection in CF by evaluating antibiotic susceptibility profiles and molecular characteristics of SCV-SA in a two large CF patient populations.
- Perform a 16-patient pilot study of a novel treatment for SCV-SA infection in CF, utilizing low dose rifampin in combination with standard anti-SA antibiotics.
These investigations will delineate the role of SCV-SA as a pathogen in CF and provide guidance to optimize treatment strategies of MSSA/MRSA CF lung infection.
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis MRSA||Drug: Rifampin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Epidemiology and Treatment of Small-colony Variant Staphylococcus Aureus in Cystic Fibrosis|
|Estimated Study Start Date :||December 2020|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
|No Intervention: Standard anti-staphylococcal antibiotic|
Experimental: Standard anti-staphylococcal antibiotic + Rifampin
Individuals with known, persistent small-colony variant MRSA, who are treated with standard anti-staphylococcal antibiotics, will be treated with their standard therapy in addition to Rifampin.
Addition of Rifampin to standard anti-Staphylococcal treatment regimen
- change in small colony variant Staph. aureus colony forming units on induced sputum respiratory culture [ Time Frame: Culture specimens obtained at: Baseline, within 2 weeks of end of standard antibiotic course (control), 1 week prior to intervention, and within 2 weeks of end of intervention ]
- change in lung function, as measured by forced expiratory volume in one second (FEV1) [ Time Frame: FEV1 measured at: Baseline, within 2 weeks of end of standard antibiotic course (control), 1 week prior to intervention, and within 2 weeks of end of intervention ]
- patient reported symptoms/quality of life, as captured in the Cystic Fibrosis Questionnaire-Revised (CFQ-R) [ Time Frame: CFQ-R administered at: Baseline, within 2 weeks of end of standard antibiotic course (control), 1 week prior to intervention, and within 2 weeks of end of intervention ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02547116
|United States, Maryland|
|Johns Hopkins University School of Medicine|
|Baltimore, Maryland, United States, 21205|
|Principal Investigator:||Mark T Jennings, MD, MHS||Johns Hopkins University|