CompletedPhase 2

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

United States37 participantsStarted 2018-04-03

Plain-language 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.

Who can participate

Age range2 Years – 45 Years

SexALL

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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

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

What they're measuring

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

Timeframe: Day 28

Trial details

NCT IDNCT03489629

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-30

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