Comparison of Antibiotics for Pseudomonas in Early CF

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Cystic Fibrosis Foundation; Cystic Fibrosis Foundation Therapeutics
• Treatments: Anti-Bacterial Agents; Ceftazidime; Tobramycin

Criteria

Inclusion Criteria:

1. 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.

2. Clinically stable as defined by:

1. No systemic anti-P. aeruginosa antibiotics in the past 2 mo, and no TOBI in the past 1 month;

2. No pulmonary exacerbation in the past 1 mo (definition furnished on request); and

3. FEV1 ≥ 70% predicted (best baseline past 6 months and at study entry) for those old enough to reliably test spirometric lung function.

Exclusion Criteria:

1. Recent (within past 2 mo) use of systemic anti-Pseudomonas antibiotics, with the exception of chronic (three times a week) azithromycin;

2. Recent (within past 2 wk) use of systemic anti-inflammatory agents;

3. Mycobacterial pathogens on AFB smear at initial bronchoscopy;

4. 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.

5. 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.

6. History of reactions to or problems with anesthesia or sedation.

7. History of reactions to or problems with aminoglycosides (medicines like tobramycin or gentamicin).

8. History of hemoptysis (coughing up blood) within 30 days prior to entry.

9. History of anemia or thrombocytopenia.

10. Administration of any investigational drug within 30 days prior to entry.

11. History of abnormal kidney function (greater than 1.5 times the upper limit of normal serum creatinine for age).

12. History of documented chronic hearing loss.

13. for children under the age of 3 months, prematurity defined as gestational age < 36 weeks.