Early Methicillin-resistant Staphylococcus Aureus (MRSA) Therapy in Cystic Fibrosis (CF)

Stopped early · Phase 2

Conditions studied: Cystic Fibrosis, Methicillin-resistant Staphylococcus Aureus

In brief

Purpose: There has been a recent, rapid increase in prevalence of Methicillin-resistant Staphylococcus aureus (MRSA) among patients with Cystic Fibrosis (22% across US CF centers in 2009). Some epidemiologic studies suggest possible worse outcomes, a recent analyses showing this with chronic but not intermittent MRSA. Given the chronic difficult to treat lung infections in CF it is unclear how the onset of MRSA should be approached. This randomized, controlled, interventional study seeks to determine if an early eradication protocol is effective for eradication of MRSA and will provide an opportunity to obtain data regarding early clinical impact of new isolation of MRSA. Participants: Cystic fibrosis patients with new isolation of MRSA from their respiratory culture on a routine clinic visit. Procedures (methods): Randomized, open-label, multi-center study comparing use of an eradication protocol to an observational group who receives the current standard of care i.e. treatment for MRSA only with pulmonary exacerbations.

Key facts

Study ID

NCT01349192

Run by

University of North Carolina, Chapel Hill

People needed

47

Starts

2011-04-01

Expected to finish

2015-05-01

Last updated by the study team

2017-05-15

Who can join

Age: 4 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female ≥ 4 and ≤ 45 years of age at the Screening Visit.
• Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:
• sweat chloride ≥ 60 mEq/liter by quantitative pilocarpine iontophoresis test (QPIT)
• two well-characterized mutations in the cystic fibrosis transmembrane conductive regulator (CFTR) gene
• Abnormal nasal potential difference (change in NPD in response to a low chloride solution and isoproteronol of less than -5 mV)
• First OR early repeat MRSA colonization defined as:
• First MRSA colonization: first documented isolation of MRSA from respiratory tract occurred ≤ 6 months prior to screening
• OR Early repeat MRSA colonization:
• MRSA was previously isolated from the respiratory tract (≤ 2 times), but this was followed by at least 1 year of documented negative cultures for MRSA as noted below:
• - At least 2 cultures performed at least 3 months apart to document 1 year of culture negativity. Each of these cultures should be documented to have been collected at least 1 week after end of any antibiotic prescription with MRSA activity.
• Patient again recently positive for MRSA from the respiratory tract (within 6 months prior to screening)
• Clinically stable with no significant changes in health status within the 14 days prior to screening
• Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study
• A repeat culture from the respiratory tract is obtained at screening but does not have to be positive to be able to enter the study.

You may not qualify if…

• Received antibiotics with activity against MRSA within 28 days prior to screening (see study manual for list of antibiotics)
• Use of an investigational agent within 28 days prior to screening
• For subjects ≥ 6 years of age: FEV1 at screening < 30% of predicted for age based on the Wang (males < 18 years, females < 16 years) or Hankinson (males ≥ 18 years, females ≥ 16 years) standardized equations
• MRSA from the screening culture resistant to rifampin OR resistant to both TMP/SMX and minocycline
• History of intolerance to oral rifampin, or topical chlorhexidine or mupirocin
• History of intolerance to both TMP/SMX and minocycline
• < 8 years of age and either allergic or intolerant to TMP/SMX or screening MRSA resistant to TMP/SMX
• ≥ 8 years of age and allergic or intolerant to TMP/SMX and screening MRSA resistant to minocycline
• ≥ 8 years of age and allergic or intolerant to minocycline and screening MRSA resistant to TMP/SMX
• For females of child bearing potential: pregnant, breastfeeding, or unwilling to use barrier contraception through Day 15 of the study
• Abnormal renal function at Screening, defined as estimated creatinine clearance <50 mL/min using the Cockcroft-Gault equation
• Abnormal liver function at the time of screening, defined as ≥2x upper limit of normal (ULN), of serum aspartate transaminase (AST) or serum alanine transaminase (ALT)
• History of solid organ or hematological transplantation
• Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.

Where it is running

• The Children's Hospital-University of Birmingham — Birmingham, Alabama, United States
• The Children's Hospital — Aurora, Colorado, United States
• University of Florida — Gainesville, Florida, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• Children's Hospitals and Clinics of Minnesota Minneapolis — Minneapolis, Minnesota, United States
• St. Louis Children's Hospital — St Louis, Missouri, United States
• N.C Memorial Hospital and N.C Children's Hospital — Chapel Hill, North Carolina, United States
• CFF Care Center & Pediatric Program Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Cook Children's Medical Center — Fort Worth, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• Seattle Children's — Seattle, Washington, United States
• University of Washington Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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