CompletedNot Applicable

Initial and Chronic Methicillin Resistant Staphylococcus Aureus (MRSA) Infection in Cystic Fibrosis (CF)

United States48 participantsStarted 2015-07

Plain-language summary

This study aims to examine features of MRSA that are associated with chronic MRSA infection and bacterial persistence despite IV antibiotic therapy. Subjects are asked to expectorate sputum and complete CF symptom diaries both at beginning and end of IV therapy.

Who can participate

Age range4 Years – 99 Years

SexALL

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Inclusion criteria

✓. Male or female with a confirmed diagnosis of CF (clinical features and positive sweat test and/or identification of 2 CF disease causing mutations).
✓. At least 4 years of age or older.
✓. Chronic infection with MRSA defined as having had MRSA positive respiratory cultures for \> 1 year with ≥ 50% of cultures being MRSA positive e.g. 2/4 of the most recent cultures grew MRSA.
✓. Being able to expectorate sputum on a consistent basis, i.e. also at the end of IV therapy.
✓. Having a pulmonary exacerbation defined for this protocol as the decision of the treating physician to start IV therapy in hospital or at home. Typically this occurs when there has been a \>5% drop in FEV1 % predicted compared to the patient's baseline and increased respiratory symptoms.

Exclusion criteria

✕. Presence / infection with B. cepacia genomovar III (=B. cenocepacia). Subjects who have undergone lung or liver transplant in the past (NOTE: patients listed for transplant are eligible)
✕. Concomitant participation and/or use of an investigational drug within 30 days of this study.
✕. Concomitant observational studies are allowed with TRI-STAR, if approved by the other study investigator or their proxy.

What they're measuring

Changes in presence of hypermutable MRSA isolates post-therapy compared to pre-therapy.

Timeframe: 2-3 weeks (course of IV antibiotics as determined by clinician)

Trial details

NCT IDNCT02684422

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-10

View on ClinicalTrials.gov More Methicillin-Resistant Staphylococcus Aureus trials