Early Methicillin-resistant Staphylococcus Aureus (MRSA) Therapy in Cystic Fibrosis (CF)

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01349192
• Date of registration: 04/05/2011
• Prospective Registration: No
• Primary sponsor: University of North Carolina, Chapel Hill
• Public title: Early Methicillin-resistant Staphylococcus Aureus (MRSA) Therapy in Cystic Fibrosis (CF) STAR-Too
• Scientific title: Early MRSA Therapy in CF - Culture Based vs. Observant Therapy (Treat or Observe) (Star-TOO - STaph Aureus Resistance - Treat or Observe)
• Date of first enrolment: April 2011
• Target sample size: 47
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01349192
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Investigator).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Chris Goss, MD
• Affiliation: University of Washington

• Name: Marianne S Muhlebach, MD
• Affiliation: UNC Children's Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Male or female = 4 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:

- sweat chloride = 60 mEq/liter by quantitative pilocarpine iontophoresis test
(QPIT)

- two well-characterized mutations in the cystic fibrosis transmembrane conductive
regulator (CFTR) gene

- Abnormal nasal potential difference (change in NPD in response to a low chloride
solution and isoproteronol of less than -5 mV)

3. First OR early repeat MRSA colonization defined as:

- First MRSA colonization: first documented isolation of MRSA from respiratory
tract occurred = 6 months prior to screening

- OR Early repeat MRSA colonization:

MRSA was previously isolated from the respiratory tract (= 2 times), but this was
followed by at least 1 year of documented negative cultures for MRSA as noted below:

-- At least 2 cultures performed at least 3 months apart to document 1 year of culture
negativity. Each of these cultures should be documented to have been collected at
least 1 week after end of any antibiotic prescription with MRSA activity.

Patient again recently positive for MRSA from the respiratory tract (within 6 months
prior to screening)

4. Clinically stable with no significant changes in health status within the 14 days
prior to screening

5. 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

A repeat culture from the respiratory tract is obtained at screening but does not have to
be positive to be able to enter the study.

Exclusion Criteria:

1. Received antibiotics with activity against MRSA within 28 days prior to screening (see
study manual for list of antibiotics)

2. Use of an investigational agent within 28 days prior to screening

3. For subjects = 6 years of age: FEV1 at screening < 30% 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 resistant to rifampin OR resistant to both TMP/SMX and
minocycline

5. History of intolerance to oral rifampin, or topical chlorhexidine or mupirocin

6. History of intolerance to both TMP/SMX and minocycline

7. < 8 years of age and either allergic or intolerant to TMP/SMX or screening MRSA
resistant to TMP/SMX

8. = 8 years of age and allergic or intolerant to TMP/SMX and screening MRSA resistant to
minocycline

9. = 8 years of age and allergic or intolerant to minocycline and screening MRSA
resistant to TMP/SMX

10. For females of child bearing potential: pregnant, breastfeeding, or unwilling to use
barrier contraception through Day 15 of the study

11. Abnormal renal function at Screening, defined as estimated creatinine clearance <50
mL/min using the Cockcroft-Gault equation

12. Abnormal liver function at the time of screening, defined as =2x upper limit of normal
(ULN), of serum aspartate transaminase (AST) or serum alanine transaminase (ALT)

13. History of solid organ or hematological transplantation

14. 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: 4 Years
Age maximum: 45 Years
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Methicillin-resistant Staphylococcus Aureus

Intervention(s)

Drug: 2% Chlorhexidine solution wipes

Drug: chlorhexidine gluconate oral rinse

Drug: Mupirocin

Drug: Trimethoprim/Sulfamethoxazole

Drug: Minocycline

Behavioral: Environmental Decontamination

Drug: Rifampin

Primary Outcome(s)

MRSA Culture Status [Time Frame: Day 28]

Secondary Outcome(s)

Pulmonary Exacerbations [Time Frame: 28 days]

Antibiotic Use (Proportion of Subjects) [Time Frame: 6 months]

Antibiotic Use (Days of Use Per Subject) [Time Frame: 6 months]

Secondary ID(s)

STAR-too-10K0

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Washington University School of Medicine

University of Florida

University of Alabama at Birmingham

CF Therapeutics Development Network Coordinating Center

University of Michigan

Cook Children's Medical Center

Seattle Children's Hospital

St. Louis Children's Hospital

University of Texas Southwestern Medical Center

Baylor College of Medicine

Children's Hospital Medical Center, Cincinnati

University of Colorado, Denver

University of Washington

Results

• Results available: Yes
• Date Posted: 15/05/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01349192