Cystic FibrosisPhase 1CAPECNCT00823238
Comparison of Antibiotics for Pseudomonas in Early CF
A Phase 1 study testing ceftazidime and tobramycin and inhaled tobramycin in people with Cystic Fibrosis, run by University of North Carolina, Chapel Hill.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 months to 16 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- ceftazidime and tobramycin and inhaled tobramycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- Jul 2004to May 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
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.
Read the 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 aeruginosa begins in early life and is clearly associated with decline (especially mucoid phenotypes), making this infection a major target of therapy. The inflammatory response to infection may also be dysregulated in CF, so that suppression of airway inflammation is a second major goal of therapy. However, "best practice" for treatment of Pseudomonas infection in early CF is not defined (several recently published commentaries available upon request) and is a critical issue currently in clinical management of CF. Inhaled tobramycin alone has been reported to be effective at short-term eradication of P. aeruginosa from bronchoalveolar lavage fluid (BALF) in children with cystic fibrosis (CF) age 3 mo-6 yr, but inflammation was unaffected by this treatment, and recurrence of infection occurred fairly quickly for mucoid strains. The ideal treatment would result in long-term reduction in both bacterial quantity and inflammation. Some bacteria in the CF airway may be both inaccessible to inhaled antibiotics, and "hidden" from BALF, by location in inspissated secretions, and P. aeruginosa may not be effectively eradicated in paranasal sinuses. Thus, it is reasonable to hypothesize that treatment with parenteral antibiotics provides better overall eradication of organisms and consequently reduced stimulus for ongoing or recurrent inflammation in the airways. We therefore propose 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
- Being tested
- ceftazidime and tobramycin, inhaled tobramycin
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ceftazidime and tobramycinDrug
inhaled tobramycinDrug
| Study group | Role | What they receive |
|---|---|---|
| systemic | Active comparator | Not described Receives: Drug: ceftazidime and tobramycin |
| inhaled | Active comparator | Not described Receives: Drug: inhaled tobramycin |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2009 (estimated)
- Study startJul 2004
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Investigators
- Terry Noah, MD, Principal investigator, UNC-CH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00823238
- Sponsor's protocol ID
- GCRC2197
- Acronym
- CAPEC
- Status last verified
- Apr 2011
- First submitted
- 29 Dec 2008
- Last updated
- 18 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Antibiotics for Pseudomonas in Early CF
- ClinicalTrials.gov ID
- NCT00823238
- Acronym / sponsor ID
- CAPEC / GCRC2197
- Conditions
- Cystic Fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Study start
- Jul 2004
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 15 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 aeruginosa begins in early life and is clearly associated with decline (especially mucoid phenotypes), making this infection a major target of therapy. The inflammatory response to infection may also be dysregulated in CF, so that suppression of airway inflammation is a second major goal of therapy. However, "best practice" for treatment of Pseudomonas infection in early CF is not defined (several recently published commentaries available upon request) and is a critical issue currently in clinical management of CF. Inhaled tobramycin alone has been reported to be effective at short-term eradication of P. aeruginosa from bronchoalveolar lavage fluid (BALF) in children with cystic fibrosis (CF) age 3 mo-6 yr, but inflammation was unaffected by this treatment, and recurrence of infection occurred fairly quickly for mucoid strains. The ideal treatment would result in long-term reduction in both bacterial quantity and inflammation. Some bacteria in the CF airway may be both inaccessible to inhaled antibiotics, and "hidden" from BALF, by location in inspissated secretions, and P. aeruginosa may not be effectively eradicated in paranasal sinuses. Thus, it is reasonable to hypothesize that treatment with parenteral antibiotics provides better overall eradication of organisms and consequently reduced stimulus for ongoing or recurrent inflammation in the airways. We therefore propose 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| systemic | Active comparator | Drug: ceftazidime and tobramycin |
| inhaled | Active comparator | Drug: inhaled tobramycin |
Who may qualify
- Ages
- 3 months to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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:
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ceftazidime and tobramycin | Drug | systemic |
| inhaled tobramycin | Drug | inhaled |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terry Noah, MD principal investigator
UNC-CH
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ceftazidime and tobramycin and inhaled tobramycin in people with Cystic Fibrosis, run by University of North Carolina, Chapel Hill.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2011.