Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
CF Therapeutics Development Network Coordinating Center
Seattle Children's Hospital
Washington University School of Medicine
University of Washington
St. Louis Childrens' Hospital
University of Colorado, Denver
Baylor College of Medicine
University of Alabama at Birmingham
Cook Children's Medical Center
University of Michigan
University of Florida
University of Texas Southwestern Medical Center
Children's Hospital Medical Center, Cincinnati
Information provided by (Responsible Party):
Marianne Muhlebach, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01349192
First received: May 4, 2011
Last updated: November 13, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention Phase
Cystic Fibrosis
Methicillin-resistant Staphylococcus Aureus
Drug: Rifampin
Drug: Trimethoprim/Sulfamethoxazole
Drug: Minocycline
Drug: Mupirocin
Drug: chlorhexidine gluconate oral rinse
Drug: 2% Chlorhexidine solution wipes
Behavioral: Environmental Decontamination
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Early MRSA Therapy in CF - Culture Based vs. Observant Therapy (Treat or Observe) (Star-TOO - STaph Aureus Resistance - Treat or Observe)

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Microbiology [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
    Proportion of subjects in each arm with MRSA negative respiratory cultures at day 28.


Secondary Outcome Measures:
  • Antibiotic Use [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    proportion of subjects treated with oral, inhaled, and IV antibiotics over the 6 month study and number of days of use.

  • Exacerbation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Proportion of subjects with a protocol defined pulmonary exacerbation between baseline and day 28 who are treated with antibiotics active against MRSA.


Estimated Enrollment: 80
Study Start Date: April 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Subjects are treated with two oral antibiotics, topical antibiotics, and are instructed to use environmental decontamination techniques.
Drug: Rifampin
Adult Dose: 300mg twice daily for 14 days. Pediatric Dose: <40kg : 15mg/kg daily for 14 days divided every 12 hours.
Other Name: Rifadin, Rimactane
Drug: Trimethoprim/Sulfamethoxazole
Adult Dose: 320/1600 orally twice daily for 14 days. Pediatric Dose: <40 kg : 8mg/kg trimethoprim / 40 mg/kg sulfamethoxazole twice a day for 14 days.
Other Name: Bactrim, Septra
Drug: Minocycline

only subjects greater or equal to 8 years of age, who are not able to tolerate TMP/SMX or whose screening MRSA is resistant to TMP/SMX should be prescribed minocycline.

Adult dose: 100 mg orally twice daily for 14 days Pediatric dose: < 50 kg : 2mg/kg orally twice daily for 14 days not to exceed 200mg per day.

Other Name: Cleeravue-M, Dynacin, Minocin, Myrac, Solodyn, Vectrin
Drug: Mupirocin
1 gram 2% nasal ointment generously applied to each nostril using a cotton swab twice daily for 14 days.
Other Name: Bactroban, Centany
Drug: chlorhexidine gluconate oral rinse
for subjects able to swish without swallowing. 0.12% chlorhexidine gluconate oral rinse twice daily for 14 days.
Drug: 2% Chlorhexidine solution wipes
whole body wash solution wipes once daily for first 5 days.
Behavioral: Environmental Decontamination

wipe down high touch surfaces and medical equipment with surface disinfecting wipes daily for the first 21 days.

wash all linens and towels in hot water once weekly for three weeks.

Other Name: Sani-Cloth Plus
No Intervention: Observational
Subjects are tracked and not treated for their MRSA. If the subject reaches a protocol defined exacerbation within the first 28 days then they will be treated per choice of their primary Pulmonologist.

  Eligibility

Ages Eligible for Study:   4 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 (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)
  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01349192

Locations
United States, Alabama
The Children's Hospital-University of Birmingham
Birmingham, Alabama, United States, 35233
United States, Colorado
The Children's Hospital
Aurora, Colorado, United States, 80045
United States, Florida
University of Florida
Gainesville, Florida, United States, 32611
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109-5212
United States, Minnesota
Children's Hospitals and Clinics of Minnesota Minneapolis
Minneapolis, Minnesota, United States, 55404
United States, Missouri
St. Louis Children's Hospital
St. Louis, Missouri, United States, 63110
United States, North Carolina
N.C Memorial Hospital and N.C Children's Hospital
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
CFF Care Center & Pediatric Program Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3026
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Washington
Seattle Children's
Seattle, Washington, United States, 98145-9807
University of Washington Medical Center
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of North Carolina, Chapel Hill
CF Therapeutics Development Network Coordinating Center
Seattle Children's Hospital
Washington University School of Medicine
University of Washington
St. Louis Childrens' Hospital
University of Colorado, Denver
Baylor College of Medicine
University of Alabama at Birmingham
Cook Children's Medical Center
University of Michigan
University of Florida
University of Texas Southwestern Medical Center
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Marianne S Muhlebach, MD UNC Children's Hospital
Principal Investigator: Chris Goss, MD University of Washington
  More Information

No publications provided

Responsible Party: Marianne Muhlebach, MD, Professor, Pediatric Pulmonolgy, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01349192     History of Changes
Other Study ID Numbers: STAR-too-10K0
Study First Received: May 4, 2011
Last Updated: November 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
MRSA
Cystic Fibrosis
Early Infection
Treatment

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Staphylococcal Infections
Bacterial Infections
Digestive System Diseases
Genetic Diseases, Inborn
Gram-Positive Bacterial Infections
Infant, Newborn, Diseases
Lung Diseases
Pancreatic Diseases
Pathologic Processes
Respiratory Tract Diseases
Chlorhexidine
Chlorhexidine gluconate
Minocycline
Sulfamethoxazole
Trimethoprim
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Local
Anti-Infective Agents, Urinary
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Dermatologic Agents
Disinfectants
Enzyme Inhibitors
Folic Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 25, 2014