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Anti-Infective Completed with Results
Early Treatment of New Onset of Methicillan Resistant Staphylococcus Aureus (MRSA) Growth in Respiratory Culture (STAR-too-10K0)
This study evaluated an eradication protocol to eliminate Methicillin-resistant Staphylococcus aureus (MRSA) from the lungs of people with CF who grew recently the bacteria in a respiratory culture. To be included in the study, participants were required to have had MRSA isolated from a respiratory culture for the first time within the 6 months prior to participation or to have had a newly positive MRSA culture after having tested negative for at least 1 year. Participants were randomly assigned to either an eradication treatment group or an observational control group. The eradication treatment included oral and topical antibiotics (14 days) plus environmental decontamination (21 days). The primary endpoint of the study, respiratory culture results for MRSA, was assessed on Day 28. During this 28-day period, the observational control group only received treatment if respiratory symptoms occurred.. All participants were observed for an additional 5 months to evaluate the impact of the eradication treatment on respiratory cultures and clinical outcomes (rates of pulmonary exacerbation, weight and lung function).
Eligibility
See other primary eligibility criteria for more information.
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Age:
4 Years to 45 Years -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
30% or greater
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Subjects must have first OR early MRSA colonization and MRSA at screening
Study Results
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What We Learned:
The eradication treatment strategy for newly-acquired MRSA was shown to significantly reduce the number of participants with positive MRSA cultures. There were no significant safety concerns associated with the eradication treatment protocol.
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Primary Findings:
Effectiveness:
This study was conducted between April 2011 and September 2014. Of the 45 participants in the study, 24 were randomized to the eradication treatment group and 21 to the observational control group. In the eradication treatment group, the majority of the participants used the topical antibiotics and performed the environmental cleaning, however they were less adherent to taking the oral antibiotics (35% of participants took less than 80%). The study planned to enroll 90 participants; however, it was stopped early by the CFFT Data Safety Monitoring Board (DSMB) due to a significant reduction in the number of participants with a positive MRSA culture at Day 28 in the treatment group. Eighteen participants in the treatment arm (82%) had a negative culture at Day 28 compared to 5 participants (26%) in the observational arm (p<0.001).
Longer-term microbiologic and clinical outcomes after Day 28 were difficult to interpret given the very high rate of oral, intravenous and inhaled antibiotics used in both study arms during the study (including the 5 month follow-up period).
Safety:
Overall, the number of adverse events did not significantly differ between treatment arms.
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Citation:
Thorax 2017;DOI 10.1136/thoraxjnl-2016-208949;72(4):318-326
For current information about the overall development status of this drug, please check the Drug Development Pipeline.
Study Design
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Study Type: ?more info
Interventional -
Randomized Study: ?more info
Yes -
Placebo Controlled: ?more info
No -
Length of Participation:
6 months -
Number of Study Visits:
5
Additional Information
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Phase: ?more info
Phase Two -
Study Sponsor: ?more info
Muhlebach, Marianne -
Study Drugs:
N/A
Eligibility
See other primary eligibility criteria for more information.
-
Age:
4 Years to 45 Years -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
30% or greater
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Subjects must have first OR early MRSA colonization and MRSA at screening
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