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STaph Aureus Resistance-Treat Early and Repeat (STAR-TER) (STAR-TER)

Primary Purpose

Cystic Fibrosis

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Trimethoprim Sulfamethoxazole (TMP/SMX)
Minocycline
Mupirocin
Chlorhexidine Gluconate
Environmental Decontamination
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring Methicillin-resistant Staphylococcus aureus (MRSA), Early infection, Treatment, Forced Expiratory Volume in 1 Second (FEV1)

Eligibility Criteria

2 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female ≥ 2 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:

    1. sweat chloride ≥ 60 milliequivalents/liter by quantitative pilocarpine iontophoresis test (QPIT)
    2. two well-characterized mutations in the cystic fibrosis transmembrane conductive regulator (CFTR) gene
    3. abnormal nasal potential difference(NPD) (change in NPD in response to a low chloride solution and isoproteronol of less than -5 mV)
  3. First OR early MRSA colonization defined as:

    1. First MRSA colonization: first documented isolation of MRSA from respiratory tract occurred ≤ 6 months prior to screening
    2. Early MRSA colonization: MRSA was previously isolated from the respiratory tract ≤ 2 times over the past 3.5 years, but this was followed by at least 1 year of documented negative cultures for MRSA
  4. MRSA is available to the central laboratory - either the incident MRSA isolate from the clinic visit or the subject is MRSA positive at the screening visit
  5. Clinically stable with no significant changes in health status within the 14 days prior to screening
  6. 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

Exclusion Criteria:

  1. Received antibiotics with activity against MRSA within 28 days prior to screening
  2. Use of an investigational agent within 28 days prior to screening
  3. For subjects ≥ 6 years of age: FEV1 at screening < 25% 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 or the most recent clinical care visit within 6 months prior to screening resistant to TMP/SMX
  5. History of intolerance to topical chlorhexidine or mupirocin
  6. History of intolerance to both TMP/SMX and minocycline
  7. < 8 years of age and allergic or intolerant to TMP/SMX
  8. ≥ 8 years of age and allergic or intolerant to TMP/SMX and MRSA isolate (from screening or clinical care visit)is resistant to minocycline
  9. For females of child bearing potential: pregnant, breastfeeding, or unwilling to use barrier contraception through Day 42 of the study
  10. Subjects with history of abnormal renal function will need screening labs showing normal function Abnormal renal function is defined as estimated creatinine clearance <50 mL/min using the:

    1. Bedside Schwartz Equation for subjects <18 years of age, and
    2. Levey Glomerular filtration rate (GFR) Equation for subjects ≥ 18 years of age.
  11. Subjects with a history of abnormal liver function will need to have screening labs showing normal transaminases. Liver dysfunction is defined as ≥3x upper limit of normal (ULN), of serum aspartate transaminase (AST) or serum alanine transaminase (ALT) or abnormal synthetic function
  12. History of solid organ or hematological transplantation
  13. 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.

Sites / Locations

  • National Jewish HealthRecruiting
  • Indiana UniversityRecruiting
  • University of Michigan Health SystemRecruiting
  • St. Louis Children's HospitalRecruiting
  • N.C. Memorial Hospital and N.C. Children's HospitalRecruiting
  • University of Texas Southwestern Medical CenterRecruiting
  • Cook Children's Medical CenterRecruiting
  • Texas Children's Hospital, Baylor College of MedicineRecruiting
  • University of Washington Medical Center and Seattle Children'sRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Subjects are treated with one oral antibiotic, one topical antibiotic, an oral rinse, and instructed to use environmental decontamination techniques. Trimethoprim Sulfamethoxazole (TMP/SMX) is the primary oral antibiotic to be used. Subjects with allergy or intolerance to TMP_SMX will use minocycline as an alternative antibiotic. Topical antibiotics are nasal Mupirocin, and the oral rinse/gurgle with 0.12% chlorhexidine gluconate.

Outcomes

Primary Outcome Measures

Proportion of STAR-TER subjects with a negative MRSA culture at Day 28 vs. observational arm of historic STAR-Too trial
Descriptive summary with corresponding 95% confidence interval.

Secondary Outcome Measures

Proportion of subjects with a protocol-defined pulmonary exacerbation between Baseline and Day 28 treated with antibiotics active against MRSA
Pulmonary exacerbation is defined as having 1 of the major criteria or 2 minor signs/symptoms and fulfillment of symptom duration. Major criteria: Absolute decrease in FEV1 of ≥ 10% from Visit 1 (Baseline), unresponsive to albuterol (in participants able to reproducibly perform spirometry) Oxygen saturation <90% on room air or absolute decrease of ≥ 5% from Visit 1 New lobar infiltrate(s) or atelectasis on chest radiograph Hemoptysis (more than streaks on more than one occasion in past week) Minor signs/symptoms: Increased work of breathing or respiratory rate New or increased adventitial sounds on lung exam Weight loss ≥5% of body weight or decrease across 1 major percentile in weight percentile for age in past 6 months Increased cough Decreased exercise tolerance or level of activity Increased chest congestion or change in sputum Signs/symptoms duration: initial symptom must have occurred for at least 5 days.
Proportion of subjects with a protocol-defined pulmonary exacerbation between Baseline and Day 28 treated with any oral, inhaled, or IV antibiotics regardless of potential activity against MRSA
Pulmonary exacerbation is defined as having 1 of the major criteria or 2 of the minor signs/symptoms and fulfillment of symptom duration. Major criteria: Absolute decrease in FEV1 of ≥ 10% from Visit 1 (Baseline), unresponsive to albuterol (in participants able to reproducibly perform spirometry) Oxygen saturation <90% on room air or absolute decrease of ≥ 5% from Visit 1 New lobar infiltrate(s) or atelectasis on chest radiograph Hemoptysis (more than streaks on more than one occasion in past week) Minor signs/symptoms: Increased work of breathing or respiratory rate New or increased adventitial sounds on lung exam Weight loss ≥5% of body weight or decrease across 1 major percentile in weight percentile for age in past 6 months Increased cough Decreased exercise tolerance or level of activity Increased chest congestion or change in sputum Signs/symptoms duration: initial symptom must have occurred for at least 5 days.
Proportion of subjects treated with oral, inhaled, and IV antibiotics over the six-month study
Time to protocol-defined pulmonary exacerbation over the six-month study
Pulmonary exacerbation is defined as having 1 of the major criteria or 2 of the minor signs/symptoms and fulfillment of symptom duration. Major criteria: Absolute decrease in FEV1 of ≥ 10% from Visit 1 (Baseline), unresponsive to albuterol (in participants able to reproducibly perform spirometry) Oxygen saturation <90% on room air or absolute decrease of ≥ 5% from Visit 1 New lobar infiltrate(s) or atelectasis on chest radiograph Hemoptysis (more than streaks on more than one occasion in past week) Minor signs/symptoms: Increased work of breathing or respiratory rate New or increased adventitial sounds on lung exam Weight loss ≥5% of body weight or decrease across 1 major percentile in weight percentile for age in past 6 months Increased cough Decreased exercise tolerance or level of activity Increased chest congestion or change in sputum Signs/symptoms duration: initial symptom must have occurred for at least 5 days.
Number of protocol-defined pulmonary exacerbations over the six-month study
Pulmonary exacerbation is defined as having 1 of the major criteria or 2 of the minor signs/symptoms and fulfillment of symptom duration. Major criteria: Absolute decrease in FEV1 of ≥ 10% from Visit 1 (Baseline), unresponsive to albuterol (in participants able to reproducibly perform spirometry) Oxygen saturation <90% on room air or absolute decrease of ≥ 5% from Visit 1 New lobar infiltrate(s) or atelectasis on chest radiograph Hemoptysis (more than streaks on more than one occasion in past week) Minor signs/symptoms: Increased work of breathing or respiratory rate New or increased adventitial sounds on lung exam Weight loss ≥5% of body weight or decrease across 1 major percentile in weight percentile for age in past 6 months Increased cough Decreased exercise tolerance or level of activity Increased chest congestion or change in sputum Signs/symptoms duration: initial symptom must have occurred for at least 5 days.
MRSA Culture Status
Proportion of subjects with a negative culture for MRSA at Day 56
Proportion of subjects with >80% compliance for study drug during the first 28 days
Compliance refers to the amount of prescribed medication consumed.

Full Information

First Posted
March 29, 2018
Last Updated
February 24, 2023
Sponsor
University of North Carolina, Chapel Hill
Collaborators
University of Washington, Cook Children's Medical Center, Indiana University, University of Michigan, University of Texas Southwestern Medical Center, St. Louis Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03489629
Brief Title
STaph Aureus Resistance-Treat Early and Repeat (STAR-TER)
Acronym
STAR-TER
Official Title
STaph Aureus Resistance-Treat Early and Repeat (STAR-TER)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 3, 2018 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
University of Washington, Cook Children's Medical Center, Indiana University, University of Michigan, University of Texas Southwestern Medical Center, St. Louis Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate the micro-biologic efficacy and safety of a streamlined treatment for early onset methicillin-resistant staphylococcus aureus (MRSA) in patients with cystic fibrosis.
Detailed Description
This is an open-label, multi-center interventional trial in Cystic Fibrosis (CF) patients with new MRSA isolated from the respiratory tract (oropharyngeal (OP) = OP swab, sputum, or bronchoscopy) at a clinical encounter. Forty-two subjects with new MRSA infection will be enrolled and will receive two weeks of oral trimethoprim-sulfamethoxazole (TMP-SMX) or minocycline depending on age, allergies and antibiotic resistance of prior isolate for 14 days, and nasal mupirocin for 5 days. Subjects old enough to do so will use oral disinfectant gurgle (0.12% chlorhexidine gluconate oral rinse) for 14 days. The primary endpoint will be the proportion of positive MRSA respiratory cultures at Day 28 and this will be compared to our prior STAR-Too results. Subjects will then have a 14 day wash-out period (i.e., no TMP-SMX or minocycline from Day 14 to Day 28) and all participants will repeat the treatment protocol from Day 29 to Day 42. Repeat cultures will be done at day 56 ± 7 days, most likely combined with their next clinic visit. Results of Day 56 cultures will be an exploratory, secondary outcome. A subsequent visit will be 3 months later with their routine clinic appointment. Any interim clinic visits will be used to obtain repeat cultures and clinical data. Assessment of MRSA culture status will be by OP swab for all subjects, with additional sputum in those who expectorate. Total duration of an individual subject's participation will be six months. Total duration of the study is expected to be 42 months, which includes data analyses and publication. Due to COVID 19 restrictions, a study amendment was filed in March 2020 for subjects currently active subjects that allowed remote study visit for V3 and V4. Cultures were collected at home and mailed to the Core Study lab, clinical case forms and surveys were completed via video visits. These changes were approved by each study site that this was relevant to i.e. 4 study sites had subjects active at that time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Methicillin-resistant Staphylococcus aureus (MRSA), Early infection, Treatment, Forced Expiratory Volume in 1 Second (FEV1)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Subjects are treated with one oral antibiotic, one topical antibiotic, an oral rinse, and instructed to use environmental decontamination techniques. Trimethoprim Sulfamethoxazole (TMP/SMX) is the primary oral antibiotic to be used. Subjects with allergy or intolerance to TMP_SMX will use minocycline as an alternative antibiotic. Topical antibiotics are nasal Mupirocin, and the oral rinse/gurgle with 0.12% chlorhexidine gluconate.
Intervention Type
Drug
Intervention Name(s)
Trimethoprim Sulfamethoxazole (TMP/SMX)
Other Intervention Name(s)
Septra, Bactrim
Intervention Description
Dosing if < 40 kg: 8 mg/kg trimethoprim/40 mg/kg trimethoprim sulfamethoxazole given twice daily for 14 days during Days 1-14 and Days 29-42. Dosing is ≥ 40 kg: 320 mg/1600 mg twice daily for 14 days during Days 1-14 and Days 29-42.
Intervention Type
Drug
Intervention Name(s)
Minocycline
Other Intervention Name(s)
Cleeravue-M, Dynacin, Minocin, Solodyn, Vectrin
Intervention Description
If a subject has an allergy to or intolerance to TMP/SMX, they may be treated with minocycline provided they are 8 years of age or older. Dosing if < 50 kg: 2 mg/kg orally twice daily for 14 days during Days 1-14 and Days 29-42. Dosing if ≥ 50 kg: 100 mg twice daily for 14 days during Days 1-14 and Days 29-42.
Intervention Type
Drug
Intervention Name(s)
Mupirocin
Other Intervention Name(s)
Bactroban, Centany
Intervention Description
1 gram 2% nasal ointment generously applied to each nostril using a cotton swab twice daily for 5 days during Days 1-5 and Days 29-33.
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine Gluconate
Other Intervention Name(s)
Dyna-Hex
Intervention Description
For subjects able to swish without swallowing, 0.12% chlorhexidine gluconate oral rinse will be used twice daily for 14 days during Days 1-14 and Days 29-42.
Intervention Type
Behavioral
Intervention Name(s)
Environmental Decontamination
Other Intervention Name(s)
Sani-Cloth wipes
Intervention Description
Subjects will be instructed to wipe down all high touch surfaces and medical equipment with surface disinfection wipes daily during Days 1-21 and Days 29-49. Subjects will also be instructed to wash all linens and towels in hot water once weekly during weeks 1-3 and weeks 5-7.
Primary Outcome Measure Information:
Title
Proportion of STAR-TER subjects with a negative MRSA culture at Day 28 vs. observational arm of historic STAR-Too trial
Description
Descriptive summary with corresponding 95% confidence interval.
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
Proportion of subjects with a protocol-defined pulmonary exacerbation between Baseline and Day 28 treated with antibiotics active against MRSA
Description
Pulmonary exacerbation is defined as having 1 of the major criteria or 2 minor signs/symptoms and fulfillment of symptom duration. Major criteria: Absolute decrease in FEV1 of ≥ 10% from Visit 1 (Baseline), unresponsive to albuterol (in participants able to reproducibly perform spirometry) Oxygen saturation <90% on room air or absolute decrease of ≥ 5% from Visit 1 New lobar infiltrate(s) or atelectasis on chest radiograph Hemoptysis (more than streaks on more than one occasion in past week) Minor signs/symptoms: Increased work of breathing or respiratory rate New or increased adventitial sounds on lung exam Weight loss ≥5% of body weight or decrease across 1 major percentile in weight percentile for age in past 6 months Increased cough Decreased exercise tolerance or level of activity Increased chest congestion or change in sputum Signs/symptoms duration: initial symptom must have occurred for at least 5 days.
Time Frame
Period ranging from start of Baseline and continuing through Day 28
Title
Proportion of subjects with a protocol-defined pulmonary exacerbation between Baseline and Day 28 treated with any oral, inhaled, or IV antibiotics regardless of potential activity against MRSA
Description
Pulmonary exacerbation is defined as having 1 of the major criteria or 2 of the minor signs/symptoms and fulfillment of symptom duration. Major criteria: Absolute decrease in FEV1 of ≥ 10% from Visit 1 (Baseline), unresponsive to albuterol (in participants able to reproducibly perform spirometry) Oxygen saturation <90% on room air or absolute decrease of ≥ 5% from Visit 1 New lobar infiltrate(s) or atelectasis on chest radiograph Hemoptysis (more than streaks on more than one occasion in past week) Minor signs/symptoms: Increased work of breathing or respiratory rate New or increased adventitial sounds on lung exam Weight loss ≥5% of body weight or decrease across 1 major percentile in weight percentile for age in past 6 months Increased cough Decreased exercise tolerance or level of activity Increased chest congestion or change in sputum Signs/symptoms duration: initial symptom must have occurred for at least 5 days.
Time Frame
Period ranging from start of Baseline and continuing through Day 28
Title
Proportion of subjects treated with oral, inhaled, and IV antibiotics over the six-month study
Time Frame
Period ranging from start of Baseline and continuing through Month 6
Title
Time to protocol-defined pulmonary exacerbation over the six-month study
Description
Pulmonary exacerbation is defined as having 1 of the major criteria or 2 of the minor signs/symptoms and fulfillment of symptom duration. Major criteria: Absolute decrease in FEV1 of ≥ 10% from Visit 1 (Baseline), unresponsive to albuterol (in participants able to reproducibly perform spirometry) Oxygen saturation <90% on room air or absolute decrease of ≥ 5% from Visit 1 New lobar infiltrate(s) or atelectasis on chest radiograph Hemoptysis (more than streaks on more than one occasion in past week) Minor signs/symptoms: Increased work of breathing or respiratory rate New or increased adventitial sounds on lung exam Weight loss ≥5% of body weight or decrease across 1 major percentile in weight percentile for age in past 6 months Increased cough Decreased exercise tolerance or level of activity Increased chest congestion or change in sputum Signs/symptoms duration: initial symptom must have occurred for at least 5 days.
Time Frame
Period ranging from start of Baseline and continuing through Month 6
Title
Number of protocol-defined pulmonary exacerbations over the six-month study
Description
Pulmonary exacerbation is defined as having 1 of the major criteria or 2 of the minor signs/symptoms and fulfillment of symptom duration. Major criteria: Absolute decrease in FEV1 of ≥ 10% from Visit 1 (Baseline), unresponsive to albuterol (in participants able to reproducibly perform spirometry) Oxygen saturation <90% on room air or absolute decrease of ≥ 5% from Visit 1 New lobar infiltrate(s) or atelectasis on chest radiograph Hemoptysis (more than streaks on more than one occasion in past week) Minor signs/symptoms: Increased work of breathing or respiratory rate New or increased adventitial sounds on lung exam Weight loss ≥5% of body weight or decrease across 1 major percentile in weight percentile for age in past 6 months Increased cough Decreased exercise tolerance or level of activity Increased chest congestion or change in sputum Signs/symptoms duration: initial symptom must have occurred for at least 5 days.
Time Frame
Period ranging from start of Baseline and continuing through Month 6
Title
MRSA Culture Status
Description
Proportion of subjects with a negative culture for MRSA at Day 56
Time Frame
Day 56
Title
Proportion of subjects with >80% compliance for study drug during the first 28 days
Description
Compliance refers to the amount of prescribed medication consumed.
Time Frame
Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female ≥ 2 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 milliequivalents/liter by quantitative pilocarpine iontophoresis test (QPIT) two well-characterized mutations in the cystic fibrosis transmembrane conductive regulator (CFTR) gene abnormal nasal potential difference(NPD) (change in NPD in response to a low chloride solution and isoproteronol of less than -5 mV) First OR early MRSA colonization defined as: First MRSA colonization: first documented isolation of MRSA from respiratory tract occurred ≤ 6 months prior to screening Early MRSA colonization: MRSA was previously isolated from the respiratory tract ≤ 2 times over the past 3.5 years, but this was followed by at least 1 year of documented negative cultures for MRSA MRSA is available to the central laboratory - either the incident MRSA isolate from the clinic visit or the subject is MRSA positive at the screening visit 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 Exclusion Criteria: Received antibiotics with activity against MRSA within 28 days prior to screening Use of an investigational agent within 28 days prior to screening For subjects ≥ 6 years of age: FEV1 at screening < 25% 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 or the most recent clinical care visit within 6 months prior to screening resistant to TMP/SMX History of intolerance to topical chlorhexidine or mupirocin History of intolerance to both TMP/SMX and minocycline < 8 years of age and allergic or intolerant to TMP/SMX ≥ 8 years of age and allergic or intolerant to TMP/SMX and MRSA isolate (from screening or clinical care visit)is resistant to minocycline For females of child bearing potential: pregnant, breastfeeding, or unwilling to use barrier contraception through Day 42 of the study Subjects with history of abnormal renal function will need screening labs showing normal function Abnormal renal function is defined as estimated creatinine clearance <50 mL/min using the: Bedside Schwartz Equation for subjects <18 years of age, and Levey Glomerular filtration rate (GFR) Equation for subjects ≥ 18 years of age. Subjects with a history of abnormal liver function will need to have screening labs showing normal transaminases. Liver dysfunction is defined as ≥3x upper limit of normal (ULN), of serum aspartate transaminase (AST) or serum alanine transaminase (ALT) or abnormal synthetic function 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marianne Muhlebach, MD
Phone
919-966-9995
Email
marianne_muhlebach@med.unc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marianne Muhlebach, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jane Gross, MD
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Chmiel, MD
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Filbrun, MD
Facility Name
St. Louis Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Coverstone, MD
Facility Name
N.C. Memorial Hospital and N.C. Children's Hospital
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marianne Muhlebach, MD
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Preeti Sharma, MD
Facility Name
Cook Children's Medical Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Schultz, MD
Facility Name
Texas Children's Hospital, Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fadel Ruiz, MD
Facility Name
University of Washington Medical Center and Seattle Children's
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chris Goss, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
27852955
Citation
Muhlebach MS, Beckett V, Popowitch E, Miller MB, Baines A, Mayer-Hamblett N, Zemanick ET, Hoover WC, VanDalfsen JM, Campbell P, Goss CH; STAR-too study team. Microbiological efficacy of early MRSA treatment in cystic fibrosis in a randomised controlled trial. Thorax. 2017 Apr;72(4):318-326. doi: 10.1136/thoraxjnl-2016-208949. Epub 2016 Nov 15.
Results Reference
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STaph Aureus Resistance-Treat Early and Repeat (STAR-TER)

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