Comparison of Antibiotics for Pseudomonas in Early CF

NCT00823238 | Completed Phase 1 DMC

• 1 other identifier: GCRC2197
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cystic Fibrosis

Study Arms (2)

systemic

ACTIVE COMPARATOR

Drug: ceftazidime and tobramycin

inhaled

ACTIVE COMPARATOR

Drug: inhaled tobramycin

Interventions

ceftazidime and tobramycin DRUG

systemic

inhaled tobramycin DRUG

inhaled

Eligibility Criteria

• Age: 3 Months - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Cystic Fibrosis Foundation: collaborator

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Ceftazidime; Tobramycin

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Cephaloridine; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nebramycin; Kanamycin; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Terry Noah, MD

  UNC-CH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 29, 2008
• First Posted: January 15, 2009
• Study Start: July 1, 2004
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: April 18, 2011

Record last verified: 2011-04