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

NCT02684422 | Completed

• 1 other identifier: 15-0636
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Methicillin-Resistant Staphylococcus Aureus; Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (2)

• Other MRSA characteristics in sputum

  2 weeks (course of IV antibiotics)

• Clinical improvement with therapy

  2-3 weeks (course of IV antibiotics)

Study Arms (1)

Cystic Fibrosis with MRSA infection

Cystic Fibrosis patients that are admitted to the hospital for IV therapy targeting MRSA will give a sputum sample and complete symptom diaries at the beginning and end of therapy. There will be no intervention administered. Inclusion criteria are ability to produce sputum and having a chronic i.e. \> 2 years of positive respiratory cultures, MRSA CF lung infection.

Other: Intervention N/A. Observational study

Interventions

Intervention N/A. Observational study OTHER

There are no interventions to the subjects other than collection of an expectorated sputum since this is an observational study; There are no study groups.See details per detailed study description.

Cystic Fibrosis with MRSA infection

Eligibility Criteria

• Age: 4 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a confirmed diagnosis of cystic fibrosis (CF), chronic MRSA who have a pulmonary exacerbation requiring IV therapy.

You may qualify if:

• 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.
• NOTE: Patients who had oral or inhaled antibiotics with or without MRSA activity but failed this outpatient therapy i.e. are changed to IV anti-MRSA antibiotics are allowed to participate.(Example: was on oral doxycycline and on admission changed to ceftaroline = eligible. On oral doxycycline that is continued on admission = not eligible).
• Patient enrollment should be prioritized to those receiving IV vancomycin or ceftaroline, with secondary consideration of patients who receive oral anti-MRSA therapy (TMP-SMX or a tetracycline derivative) that was initiated on hospital admission.
• Patients on linezolid will not be included as this medication is given orally and IV and may confound analyses.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (3)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

* Sputum * Blood

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Marianne S Muhlebach, MD

  University of NC Chapel Hill, Dept Pediatrics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2015
• First Posted: February 18, 2016
• Study Start: July 1, 2015
• Primary Completion: October 1, 2021
• Study Completion: December 1, 2021
• Last Updated: January 20, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)