Status:
COMPLETED
Comparison of Antibiotics for Pseudomonas in Early CF
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Cystic Fibrosis Foundation
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
3-16 years
Phase:
PHASE1
Brief Summary
This is a prospective, randomized clinical trial comparing the effects of these 2 modes of antibiotic treatment on BALF inflammation in young, P. aeruginosa-positive CF patients.
Detailed Description
Cystic fibrosis (CF) is a genetic disorder which is typically fatal during early adulthood, due to progressive bronchiectasis and respiratory failure. Chronic lung infection with Pseudomonas aeruginos...
Eligibility Criteria
Inclusion
- Positive respiratory culture (sputum, BALF, or deep pharyngeal culture) in the past 3 months for P. aeruginosa. Those who are culture positive for both P. aeruginosa and additional bacteria (S. aureus, H. influenzae) would also be eligible (but see microbiologic exclusions below). Children with either first isolate or chronic/repeated P. aeruginosa infection are eligible.
- Clinically stable as defined by:
- No systemic anti-P. aeruginosa antibiotics in the past 2 mo, and no TOBI in the past 1 month;
- No pulmonary exacerbation in the past 1 mo (definition furnished on request); and
- FEV1 ≥ 70% predicted (best baseline past 6 months and at study entry) for those old enough to reliably test spirometric lung function.
Exclusion
- Recent (within past 2 mo) use of systemic anti-Pseudomonas antibiotics, with the exception of chronic (three times a week) azithromycin;
- Recent (within past 2 wk) use of systemic anti-inflammatory agents;
- Mycobacterial pathogens on AFB smear at initial bronchoscopy;
- Multiple-drug resistant (MDR)-P. aeruginosa, or oxacillin-resistant S. aureus (ORSA) on respiratory cultures in the past 3 months. If either MDR-P. aeruginosa, or ORSA are isolated at the initial bronchoscopy, subjects will be excluded and results discussed with primary caregiver.
- Viral pathogens are occasionally isolated from BALF but this may take 2-3 weeks. Thus, any subjects with this result after initial bronchoscopy will likely have completed the treatment protocol, but would not undergo bronchoscopy #2.
- History of reactions to or problems with anesthesia or sedation.
- History of reactions to or problems with aminoglycosides (medicines like tobramycin or gentamicin).
- History of hemoptysis (coughing up blood) within 30 days prior to entry.
- History of anemia or thrombocytopenia.
- Administration of any investigational drug within 30 days prior to entry.
- History of abnormal kidney function (greater than 1.5 times the upper limit of normal serum creatinine for age).
- History of documented chronic hearing loss.
- for children under the age of 3 months, prematurity defined as gestational age \< 36 weeks.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00823238
Start Date
July 1 2004
End Date
May 1 2008
Last Update
April 18 2011
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