Richard B. Moss
EPIC Clinical Study
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
The purpose of this study is to learn answers to questions regarding treatment of initial Pa infection in patients with CF. Specifically, to determine the most effective and safest treatment with antimicrobial therapy and the best timing for treatment intervention for Pa infection.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: Tobramycin solution for inhalation
Phase:
Phase 3Eligibility
Ages Eligible for Study:
1 years to 12 yearsGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
1 Male or female >/=1 year and </=12 years of age at enrollment.
2 Diagnosis of CF based upon the criteria established by the 1997 CF Consensus Conference: (i) Sweat chloride > 60 mEq/L by quantitative pilocarpine iontophoresis; or (ii) genotype with two identifiable mutations consistent with CF; or (iii) an abnormal nasal transepithelial potential difference and (iv) one or more clinical features consistent with CF.
3 Participants > 15 months of age: documented new onset of positive oropharyngeal, sputum or lower respiratory tract culture for Pa within six months prior to the Baseline Visit, defined as either: a) first lifetime documented Pa positive culture; or b) Pa recovered after at least a two-year history of Pa negative respiratory cultures (>/=1 culture/ year).
4 Participants 12 - 15 months of age: at least one positive oropharyngeal, sputum or lower respiratory tract culture for Pa since birth or CF diagnosis.
5 Clinically stable with no evidence of any significant respiratory symptoms and/or physical or chest radiograph findings at screening that would require administration of intravenous anti-pseudomonal antibiotics, oxygen supplementation, and/or hospitalization.
6 Signed informed consent by parent or legal guardian and applicable participant assent.
Key Exclusion Criteria:
1 History of aminoglycoside hypersensitivity or adverse reaction to inhaled aminoglycoside.
2 History of hypersensitivity or adverse reaction to ciprofloxacin or other fluoroquinolone.
3 History of persistent, unresolved hearing loss documented by audiometric testing on at least two occasions and not associated with middle ear disease or an abnormal tympanogram.
4 Abnormal renal function at the Baseline Visit (defined as serum creatinine greater than 1.5 times the upper limit of normal for age).
5 Abnormal liver function tests at the Baseline Visit (defined as ALT and/or AST greater than 2 times the upper limit of normal range).
6 Administration of any investigational drug within 30 days prior to the Baseline Visit.
7 Administration of loop diuretics, phenytoin, warfarin, theophylline or other methyl-xanthines /=30 days prior to the Baseline Visit.
8 Administration of more than one course (at least 10 continuous days of therapy) of intravenous antipseudomonal antibiotics or more than one course (at least 28 continuous days of therapy) of inhaled antipseudomonal antibiotics within two years prior to the Baseline Visit. Intravenous or inhaled antipseudomonal antibiotics must be completed >30 days prior to the Baseline Visit.
9 Chronic macrolide use (more than 90 day duration) within 3 months prior to the Baseline Visit.
10 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.
Additional Study Details
Official Title:
Effectiveness and Safety of Intermittent Antimicrobial Therapy for the Treatment of New Onset Pseudomonas aeruginosa (Pa) Airway Infection in Young Patients with Cystic Fibrosis (Protocol # EPIC-001)Anticipated start date:
2/1/2004Lead Sponsor:
National Cystic Fibrosis Foundation & NIHInvestigator(s):
- Richard B Moss
- Colleen Dunn RCP
- Yan Ki Angela Leung
- Carol K. Conrad
- Terry Earl Robinson
- Dr Nanci Yuan
- Lauren J Witcoff
- Zoe Davies RN
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
ParallelEndpoints:
Safety/EfficacyPrimary Outcomes:
- Clinical endpoint: time to first exacerbation requiring IV antibiotics and/or hospitalization
Secondary Outcomes:
- Microbiologic endpoint
Total Number to be Enrolled:
300Total Number to be Enrolled at Stanford:
5More Information
Secondary ID(s):
- IRB# 350
- eProtocol# 1329
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
11/15/2007PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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