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Table 1 Study inclusion and exclusion criteria

From: Eradication strategy for persistent methicillin-resistant Staphylococcus aureus infection in individuals with cystic fibrosis—the PMEP trial: study protocol for a randomized controlled trial

Inclusion criteria

Exclusion criteria

Male or female ≥12 years of age

An acute upper or lower respiratory infection, pulmonary exacerbation, or change in routine therapy (including antibiotics) for pulmonary disease within 42 days of the Day 1 visit (2 weeks prior to screening visit)

Confirmed diagnosis of CF based on the following criteria:

Individuals on continuous inhaled antibiotics without interruption who are not willing to substitute vancomycin or placebo for their scheduled inhaled antibiotic during days 0–28 of the study

   1. Positive sweat chloride >60 mEq/L (by pilocarpine iontophoresis) and/or

   2. A genotype with two identifiable mutations consistent with CF or abnormal nasal potential difference, and

   3. One or more clinical features consistent with the CF phenotype

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

Use of oral or inhaled anti-MRSA drugs within two weeks of the screening visit

Two positive MRSA respiratory cultures in the last 2 years at least 6 months apart, plus a positive MRSA respiratory culture at the screening visit and run-in (Day −14) visit

History of intolerance to inhaled vancomycin or inhaled albuterol

At least 50% of respiratory cultures from the time of the first MRSA culture (in the last 2 years) have been positive for MRSA

History of intolerance to rifampin or both trimethorpim/sulfamethoxazole (TMP/SMX) and doxycycline

FEV1 > 30% of predicted normal for age, gender, and height at screening

Resistance to rifampin or both TMP/SMX and doxycycline at screening

Females of childbearing potential must agree to practice an acceptable method of birth control (in the opinion of the investigator), including abstinencea. Female patients who utilize hormonal contraceptives as a birth control method must have used the same method for at least 3 months before study dosing

Resistance to vancomycin at screening

 

Abnormal renal function, defined as creatinine clearance <50 mL/min using the Cockcroft-Gault equation for adults or Schwartz equation in children, at screening

 

Abnormal liver function, defined as ≥3x upper limit of normal, of serum aspartate transaminase or serum alanine transaminase, or known cirrhosis at the time of screening

 

Serum hematology or chemistry screening results which in the judgment of the investigator would interfere with completion of the study

 

History of or listed for solid organ or hematological transplantation

 

History of sputum culture with non-tuberculous Mycobacteria in the last 6 months

 

History of sputum culture with Burkholderia Cepacia in the last year

 

Planned continuous use of soft contact lenses while taking rifampin and no access to glasses

 

Current use of oral corticosteroids in doses exceeding the equivalent of 10 mg prednisone a day or 20 mg prednisone every other day

 

Taking voriconazole and unable to discontinue its use from run-in visit to Day 29 end-of-treatment visit

 

Administration of any investigational drug or device within 28 days of screening or within 6 half-lives of the investigational drug (whichever is longer)

 

Patients on inhaled antibiotics must have been on the same regimen for the 4 months prior to screening

 

Female patients of childbearing potential who are pregnant or lactating, or plan on becoming pregnant

 

Any serious or active medical or psychiatric illness, which in the opinion of the investigator, would interfere with patient treatment, assessment, or adherence to the protocol

  1. a) Full details available in protocol.