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

This study has been terminated.
(Interim review showed a statistically significant treatment effect and the DMC recommended that the study be stopped with ongoing follow-up of enrolled subjects)
Sponsor:
Collaborators:
CF Therapeutics Development Network Coordinating Center
Seattle Children's Hospital
Washington University School of Medicine
University of Washington
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
St. Louis Children's Hospital
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: April 5, 2017
Last verified: April 2017
May 4, 2011
April 5, 2017
April 2011
January 2015   (Final data collection date for primary outcome measure)
MRSA Culture Status [ Time Frame: Day 28 ]
Proportion of subjects with a negative culture for MRSA at Day 28.
Microbiology [ Time Frame: Day 28 ]
Proportion of subjects in each arm with MRSA negative respiratory cultures at day 28.
Complete list of historical versions of study NCT01349192 on ClinicalTrials.gov Archive Site
  • Antibiotic Use (Proportion of Subjects) [ Time Frame: 6 months ]
    Proportion of subjects treated with oral, inhaled, and IV antibiotics over the 6 month study.
  • Antibiotic Use (Days of Use Per Subject) [ Time Frame: 6 months ]
    Days of use of oral, inhaled, and IV antibiotics over the 6 month study.
  • Pulmonary Exacerbations [ Time Frame: 28 days ]
    Proportion of subjects with a protocol-defined pulmonary exacerbation (PE) between baseline and day 28 who are treated with antibiotics active against MRSA.
  • Antibiotic Use [ Time Frame: 6 months ]
    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 ]
    Proportion of subjects with a protocol defined pulmonary exacerbation between baseline and day 28 who are treated with antibiotics active against MRSA.
Not Provided
Not Provided
 
Early Methicillin-resistant Staphylococcus Aureus (MRSA) Therapy in Cystic Fibrosis (CF)
Early MRSA Therapy in CF - Culture Based vs. Observant Therapy (Treat or Observe) (Star-TOO - STaph Aureus Resistance - Treat or Observe)

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.

The STAR-too study is a randomized, open label, multi-center study in CF patients with new MRSA isolated from the respiratory tract (sputum or oropharyngeal (OP) swab). The purpose of the study is to compare use of a two week eradication treatment protocol to an observational group treated for MRSA only when respiratory symptoms meet the criteria for a protocol defined pulmonary exacerbation during the first 28 days of the study. A total of 90 participants, four years of age or older, with new MRSA infection are planned to be randomized in a 1:1 fashion to either the treatment arm or to the observational control arm. Randomization is stratified by age, P. aeruginosa status at screening and site. Each participant randomized to the treatment arm receives two oral antibiotics for 14 days, topical antibacterial treatment of skin and nares, and a three week environmental decontamination for high risk areas and equipment. Each participant randomized to the observational control arm is followed clinically with usual care except to treat new or worsening pulmonary symptoms with antibiotics between screening and Day 28 only when participant meets criteria for a protocol defined exacerbation. Participants continue in the study for 6 months with study visits at Day 84 and Day 168 corresponding with their normal quarterly visits, this extension of observation provides additional data regarding natural history of MRSA infection and durability of the eradication protocol. The primary outcome is the proportion of participants with MRSA eradicated from respiratory tract cultures at Day 28. The secondary outcomes number of, and time to, pulmonary exacerbations, and use of antibiotics.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Investigator
Masking Description:
Although this is an open-label study, the PIs and operational study team will remain blinded to the study arm assignments of the aggregate study population and will not view aggregate study results by study arm until after database lock.
Primary Purpose: Treatment
  • Cystic Fibrosis
  • Methicillin-resistant Staphylococcus Aureus
  • 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
  • Experimental: Treatment
    Subjects are treated with two oral antibiotics, topical antibiotics, and are instructed to use environmental decontamination techniques.
    Interventions:
    • Drug: Rifampin
    • Drug: Trimethoprim/Sulfamethoxazole
    • Drug: Minocycline
    • Drug: Mupirocin
    • Drug: chlorhexidine gluconate oral rinse
    • Drug: 2% Chlorhexidine solution wipes
    • Behavioral: Environmental Decontamination
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
47
May 2015
January 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
4 Years to 45 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01349192
STAR-too-10K0
Yes
Not Provided
Plan to Share IPD: No
Marianne Muhlebach, MD, University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
  • CF Therapeutics Development Network Coordinating Center
  • Seattle Children's Hospital
  • Washington University School of Medicine
  • University of Washington
  • 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
  • St. Louis Children's Hospital
Principal Investigator: Marianne S Muhlebach, MD UNC Children's Hospital
Principal Investigator: Chris Goss, MD University of Washington
University of North Carolina, Chapel Hill
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP