Azithromycin in Patients With CF, Infected With Burkholderia Cepacia Complex
NCT00298922
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Informed consent and verbal assent as appropriate has been provided by the subject
- Ability to comply with medication use, study visits and study procedures as judged by the site Investigator
- Diagnosis of CF as defined by two or more clinical features of CF and a documented sweat chloride > 60 mEq/L by quantitative pilocarpine iontophoresis test or a genotype showing two well characterized disease causing mutations
- > 18 years of age
- Body weight > 40 kg
- BCC present in a sputum/throat culture > 1 year prior to screening and at screening
- FEV1 % predicted > 30% as calculated by the Knudsen reference equations
- Room air oximetry > 88% at rest
- Post-menarche females must be surgically sterile or using an effective form of contraception
- Predicted to live > 1 year and clinically stable at that time of enrollment as judged by the investigator.
- History of chronic macrolide use, defined as regular macrolide antibiotic use within a
three month period prior to enrollment in the study.
- AST or ALT > 2.5 times the upper limit of normal performed at the local laboratories
on two occasions prior to randomization.
- Investigational drug use within 30 days of screening
- History of alcohol, illicit drug or medication abuse within 1 year of screening
- Use of intravenous antibiotics or oral antibiotics within 14 days of screening.
- Use of low dose oral antibiotics (e.g. macrolides, tetracycline, sulfa) for acne or
other conditions within 30 days of screening
- Use of systemic corticosteroids (> 20 mg of prednisone per day) within 30 days of
screening
- Initiation of TOBI®, high dose ibuprofen, or rhDNase within 60 days of screening
- History of lung transplantation or currently on lung transplant list
- History of allergy to a macrolide antibiotic
- AFB smear positive at screening suggesting current NTM infection.
- Positive serum pregnancy test at screening (to be performed on all post-menarche
females)
- Absolute neutrophil count < 1000 performed at the local laboratories on two occasions
prior to randomization
- Creatinine > 1.5 times normal performed at the local laboratories on two occasions
prior to randomization.
- Chest x-ray changes or physical findings at screening that would compromise the safety
of the patient or the quality of the study data
- Other major organ dysfunction
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Toronto, Ontario
- Los Angeles, California
- Minneapolis, Minnesota
- Salt Lake City, Utah
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Azithromycin in Patients With CF, Infected With Burkholderia Cepacia Complex | |||
Official Title ICMJE | Phase II, Randomized, Double Blind, Placebo-Controlled Trial of Azithromycin in Patients With CF, Chronically Infected With Burkholderia Cepacia Complex | |||
Brief Summary | Pulmonary infection with Burkholderia cepacia complex (BCC) in patients with CF is often associated with a more rapid decline in lung function. Because of the resistance of BCC to many antibiotics, treatment options are often limited. New therapies to improve outcomes for patients infected with BCC are needed. However, because of the unpredictable nature of this pulmonary infection in CF, patients with BCC infection have been excluded from many CF therapeutic trials. Recent published trials in the United States, Australia, and the United Kingdom have all demonstrated clinical benefits from prolonged administration of azithromycin in CF. In these trials, the vast majority of patients were chronically infected with Pseudomonas aeruginosa. Patients with BCC were excluded from the US and UK trials, and only four patients with BCC infection were enrolled in the Australian trial. Thus, the effectiveness of azithromycin in CF patients infected with BCC is largely unknown and deserves further study. The two main ways by which azithromycin is thought to help with the chronic lung infections seen in CF are by [a] reducing inflammation and [b] direct effects on the bacteria, in particular P. aeruginosa. BCC pulmonary infection in CF is often associated with a large inflammatory response similar to or more severe than P. aeruginosa infection. If azithromycin works mainly by an anti-inflammatory mechanism, it should also be helpful in CF patients infected with BCC. Alternatively, azithromycin could have a direct effect on BCC as seen with P. aeruginosa as the two bacteria have many similarities. | |||
Detailed Description | STUDY DESIGN
| |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE | Cystic Fibrosis | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Estimated Enrollment ICMJE | 45 | |||
Original Enrollment ICMJE | Same as current | |||
Estimated Study Completion Date ICMJE | October 2009 | |||
Estimated Primary Completion Date | February 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 19 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Canada | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00298922 | |||
Other Study ID Numbers ICMJE | AZ 0003 TULLIS04A0 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Dr. Elizabeth Tullis, St. Michael's Hospital | |||
Study Sponsor ICMJE | St. Michael's Hospital, Toronto | |||
Collaborators ICMJE |
| |||
Investigators ICMJE |
| |||
PRS Account | St. Michael's Hospital, Toronto | |||
Verification Date | July 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |