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Anti-Infective Completed with Results

Persistent Methicillin Resistant Staphylococcus Aureus (MRSA) Growth in Respiratory Culture (DASENB10A0,PMEP11K1, JENNIN16K0, CHMIEL16K0)

This study evaluated the safety and effectiveness of inhaled vancomycin to eliminate the bacterium, methicillin-resistant Staphylococcus aureus (MRSA) in people with CF who have persistent MRSA infection.

 Participants were randomized to receive 28 days of either twice daily inhaled vancomycin (250 mg) or placebo. All participants also received oral antibiotics. This included rifampin (at 600 mg) daily and trimethoprim/sulfamethoxazole (TMP/SMX) twice a day (two double strength tablets). If the participant was allergic to TMP/SMX or if the bacterial culture indicated that their MRSA was resistant to TMP/SMX then they were given oral doxycycline instead of TMP/SMX. Additionally, participants used topical decontamination. They used a nose ointment (mupirocin 2%) applied into each nostril twice a day for five days and Hibiclens liquid skin cleanser packets (4% chlorhexidine gluconate) three times a week for four weeks. Finally, participants used environmental decontamination by wiping down frequently touched surfaces with Sani-Cloth Alcohol Free Germicidal wipes and laundering their bed linens and towels in hot water weekly for the first three weeks of the study.

Eligibility

  • Age:

    12 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    40% or greater

For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.

Study Results

  • What We Learned:

    This study found that there was no significant difference in eliminating MRSA for participants taking inhaled vancomycin compared to those taking placebo.  Additionally, 28% of participants receiving inhaled vancomycin withdrew from the study due to an adverse event related to the vancomycin. 

  • Primary Findings:

    Effectiveness:

    This study was conducted between October 2012 and March 2017. In the study, 29 participants received the oral antibiotics TMP/SMX or doxycycline and either inhaled vancomycin (N=14) or placebo (N=15). 18 of the 29 participants received oral rifampin in addition. Four participants who received inhaled vancomycin withdrew from the study. The study did not reach its goal of including 40 participants due to challenges with enrollment.

     

    The primary efficacy measure was the MRSA sputum culture status one month after completing the treatment period in participants receiving inhaled vancomycin versus those receiving placebo. This study did not meet its primary goal. One month after the treatment period, 2/10 (20%) participants receiving inhaled vancomycin and 3/15 (20%) participants receiving placebo had a MRSA negative sputum culture.

     

    Additional evaluations of lung function, quality of life questionnaires (CFQ-R), and the amount of MRSA bacteria in the sputum after treatment were also recorded. No significant differences were seen between those receiving inhaled vancomycin those receiving placebo.

    Safety:

    Four participants (4/14, 28%) who received inhaled vancomycin withdrew from the study due to lung spasm (bronchospasm), chest tightness or difficulty breathing, all of which were thought to be related to the inhaled vancomycin. The overall number of adverse events was similar between the two groups (40 in the inhaled vancomycin group and 41 in the placebo group).

  • Citation:

    J Cyst Fibros ;DOI 10.1016/j.jcf.2018.07.005 [Epub ahead of print]

For current information about the overall development status of this drug, please check the Drug Development Pipeline.

Study Design

  • Study Type: ?more info

    Interventional

  • Randomized Study: ?more info

    Yes

  • Placebo Controlled: ?more info

    No

  • Length of Participation:

    8 months

  • Number of Study Visits:

    7

Additional Information

  • Phase: ?more info

    Not Applicable

  • Study Sponsor: ?more info

    Boyle, Michael

  • Study Drugs:

    N/A

Eligibility

  • Age:

    12 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    40% or greater

For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.

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