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 range

4 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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