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

• Register: ClinicalTrials.gov
• Last refreshed on: 15 April 2024
• Main ID: NCT03489629
• Date of registration: 29/03/2018
• Prospective Registration: Yes
• Primary sponsor: University of North Carolina, Chapel Hill
• Public title: STaph Aureus Resistance-Treat Early and Repeat (STAR-TER) STAR-TER
• Scientific title: STaph Aureus Resistance-Treat Early and Repeat (STAR-TER)
• Date of first enrolment: April 3, 2018
• Target sample size: 42
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03489629
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Marianne Muhlebach, MD
• Affiliation: University of North Carolina, Chapel Hill

• Name: Marianne Muhlebach, MD

Key inclusion & exclusion criteria

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.



Age minimum: 2 Years
Age maximum: 45 Years
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Behavioral: Environmental Decontamination

Drug: Chlorhexidine Gluconate

Drug: Trimethoprim Sulfamethoxazole (TMP/SMX)

Drug: Minocycline

Drug: Mupirocin

Primary Outcome(s)

Proportion of STAR-TER subjects with a negative MRSA culture at Day 28 vs. observational arm of historic STAR-Too trial [Time Frame: Day 28]

Secondary Outcome(s)

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]

Number of protocol-defined pulmonary exacerbations over the six-month study [Time Frame: Period ranging from start of Baseline and continuing through Month 6]

MRSA Culture Status [Time Frame: Day 56]

Proportion of subjects with a protocol-defined pulmonary exacerbation between Baseline and Day 28 treated with antibiotics active against MRSA [Time Frame: Period ranging from start of Baseline and continuing through Day 28]

Proportion of subjects with >80% compliance for study drug during the first 28 days [Time Frame: Day 28]

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 [Time Frame: Period ranging from start of Baseline and continuing through Day 28]

Time to protocol-defined pulmonary exacerbation over the six-month study [Time Frame: Period ranging from start of Baseline and continuing through Month 6]

Secondary ID(s)

17-2144

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

St. Louis Children's Hospital

University of Texas Southwestern Medical Center

Indiana University

University of Washington

Cook Children's Medical Center

University of Michigan