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

Information source: University of North Carolina, Chapel Hill
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cystic Fibrosis; Methicillin-resistant Staphylococcus Aureus

Intervention: Rifampin (Drug); Trimethoprim/Sulfamethoxazole (Drug); Minocycline (Drug); Mupirocin (Drug); chlorhexidine gluconate oral rinse (Drug); 2% Chlorhexidine solution wipes (Drug); Environmental Decontamination (Behavioral)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: University of North Carolina, Chapel Hill

Official(s) and/or principal investigator(s):
Marianne S Muhlebach, MD, Principal Investigator, Affiliation: UNC Children's Hospital
Chris Goss, MD, Principal Investigator, Affiliation: University of Washington


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.

Clinical Details

Official title: Early MRSA Therapy in CF - Culture Based vs. Observant Therapy (Treat or Observe) (Star-TOO - STaph Aureus Resistance - Treat or Observe)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Microbiology

Secondary outcome:

Antibiotic Use



Minimum age: 4 Years. Maximum age: 45 Years. Gender(s): Both.


Inclusion Criteria: 1. Male or female ≥ 4 and ≤ 45 years of age at the Screening Visit. 2. 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


- 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)

3. 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) 4. Clinically stable with no significant changes in health status within the 14 days prior to screening 5. 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. Exclusion Criteria: 1. Received antibiotics with activity against MRSA within 28 days prior to screening (see study manual for list of antibiotics) 2. Use of an investigational agent within 28 days prior to screening 3. 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 4. MRSA from the screening culture resistant to rifampin OR resistant to both TMP/SMX and minocycline 5. History of intolerance to oral rifampin, or topical chlorhexidine or mupirocin 6. History of intolerance to both TMP/SMX and minocycline 7. < 8 years of age and either allergic or intolerant to TMP/SMX or screening MRSA resistant to TMP/SMX 8. ≥ 8 years of age and allergic or intolerant to TMP/SMX and screening MRSA resistant to minocycline 9. ≥ 8 years of age and allergic or intolerant to minocycline and screening MRSA resistant to TMP/SMX 10. For females of child bearing potential: pregnant, breastfeeding, or unwilling to use barrier contraception through Day 15 of the study 11. Abnormal renal function at Screening, defined as estimated creatinine clearance <50 mL/min using the Cockcroft-Gault equation 12. 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) 13. History of solid organ or hematological transplantation 14. 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.

Locations and Contacts

The Children's Hospital-University of Birmingham, Birmingham, Alabama 35233, United States

The Children's Hospital, Aurora, Colorado 80045, United States

University of Florida, Gainesville, Florida 32611, United States

University of Michigan Health System, Ann Arbor, Michigan 48109-5212, United States

Children's Hospitals and Clinics of Minnesota Minneapolis, Minneapolis, Minnesota 55404, United States

St. Louis Children's Hospital, St. Louis, Missouri 63110, United States

N.C Memorial Hospital and N.C Children's Hospital, Chapel Hill, North Carolina 27599, United States

CFF Care Center & Pediatric Program Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio 45229-3026, United States

University of Texas Southwestern Medical Center, Dallas, Texas 75390, United States

Cook Children's Medical Center, Fort Worth, Texas 76104, United States

Baylor College of Medicine, Houston, Texas 77030, United States

Seattle Children's, Seattle, Washington 98145-9807, United States

University of Washington Medical Center, Seattle, Washington 98195, United States

Additional Information

Starting date: April 2011
Last updated: June 11, 2015

Page last updated: August 23, 2015

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