ACTIVE_NOT_RECRUITING

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

Conditions

Cystic Fibrosis Methicillin-resistant Staphylococcus aureus (MRSA)Early infection Treatment Forced Expiratory Volume in 1 Second (FEV1)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2018-04-03

Study Completion:2025-12-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03489629

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 45 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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	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.

Inclusion Criteria

Exclusion 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

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.

Contacts and Locations

Principal Investigator

Marianne Muhlebach, MD

PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Study Locations (Sites)

National Jewish Health

Denver, Colorado, 80206

United States

Indiana University

Indianapolis, Indiana, 46202

United States

University of Michigan Health System

Ann Arbor, Michigan, 48109

United States

St. Louis Children's Hospital

Saint Louis, Missouri, 63110

United States

N.C. Memorial Hospital and N.C. Children's Hospital

Chapel Hill, North Carolina, 27599

United States

University of Texas Southwestern Medical Center

Dallas, Texas, 75390

United States

Cook Children's Medical Center

Fort Worth, Texas, 76104

United States

Texas Children's Hospital, Baylor College of Medicine

Houston, Texas, 77030

United States

University of Washington Medical Center and Seattle Children's

Seattle, Washington, 98195

United States

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

Marianne Muhlebach, MD, PRINCIPAL_INVESTIGATOR, University of North Carolina, Chapel Hill

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-04-03

Study Completion Date2025-12-30

Study Record Updates

Study Start Date2018-04-03

Study Completion Date2025-12-30

Terms related to this study

Keywords Provided by Researchers

Methicillin-resistant Staphylococcus aureus (MRSA)
Early infection
Treatment
Forced Expiratory Volume in 1 Second (FEV1)

Additional Relevant MeSH Terms

Cystic Fibrosis