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

NCT03489629 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: 17-2144
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 9

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.

Conditions

Cystic Fibrosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 28

Secondary Outcomes (7)

• Proportion of subjects with a protocol-defined pulmonary exacerbation between Baseline and Day 28 treated with antibiotics active against MRSA

  Period ranging from start of Baseline and continuing through 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

  Period ranging from start of Baseline and continuing through Day 28

• Proportion of subjects treated with oral, inhaled, and IV antibiotics over the six-month study

  Period ranging from start of Baseline and continuing through Month 6

• Time to protocol-defined pulmonary exacerbation over the six-month study

  Period ranging from start of Baseline and continuing through Month 6

• Number of protocol-defined pulmonary exacerbations over the six-month study

  Period ranging from start of Baseline and continuing through Month 6

Study Arms (1)

Treatment

EXPERIMENTAL

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.

Drug: Trimethoprim Sulfamethoxazole (TMP/SMX); Drug: Minocycline; Drug: Mupirocin; Drug: Chlorhexidine Gluconate; Behavioral: Environmental Decontamination

Interventions

Trimethoprim Sulfamethoxazole (TMP/SMX) DRUG

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.

Also known as: Septra, Bactrim

Treatment

Minocycline DRUG

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.

Also known as: Cleeravue-M, Dynacin, Minocin, Solodyn, Vectrin

Treatment

Mupirocin DRUG

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.

Also known as: Bactroban, Centany

Treatment

Chlorhexidine Gluconate DRUG

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.

Also known as: Dyna-Hex

Treatment

Environmental Decontamination BEHAVIORAL

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.

Also known as: Sani-Cloth wipes

Treatment

Eligibility Criteria

• Age: 2 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• University of Washington: collaborator
• Cook Children's Medical Center: collaborator
• Indiana University: collaborator
• University of Michigan: collaborator
• University of Texas Southwestern Medical Center: collaborator
• St. Louis Children's Hospital: collaborator

Study Sites (9)

National Jewish Health

Denver, Colorado, 80206, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

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

Chapel Hill, North Carolina, 27599, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Cook Children's Medical Center

Fort Worth, Texas, 76104, United States

Location

Texas Children's Hospital, Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University of Washington Medical Center and Seattle Children's

Seattle, Washington, 98195, United States

Location

Related Publications (1)

• 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.

  PMID: 27852955 BACKGROUND

MeSH Terms

Conditions

Cystic Fibrosis; Infections

Interventions

Trimethoprim, Sulfamethoxazole Drug Combination; Minocycline; Mupirocin; chlorhexidine gluconate

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Trimethoprim; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Epoxy Compounds; Ethers, Cyclic; Ethers; Pyrans; Fatty Acids; Lipids

Study Officials

• Marianne Muhlebach, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2018
• First Posted: April 5, 2018
• Study Start: April 3, 2018
• Primary Completion: September 30, 2025
• Study Completion: January 31, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

US (9)