Cystic FibrosisNCT00153634
Standard vs. Biofilm Susceptibility Testing in Cystic Fibrosis (CF)
A study testing IV amikacin, PO azithromycin and IV ceftazidime in people with Cystic Fibrosis and Chronic Bronchitis, run by Seattle Children's Hospital at 8 sites in United States.
Trial summary
This was a randomized multi-center clinical trial to compare the microbiological efficacy, clinical efficacy, and safety of using standard versus biofilm susceptibility testing of P. aeruginosa sputum isolates to guide antibiotic selection for treatment of airway infection in clinically stable patients with CF. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Cystic Fibrosis, Chronic Bronchitis
- What is being tested?
- IV amikacin, PO azithromycin and IV ceftazidime
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 8 sitesUnited States
- Study dates
- Mar 2004to Nov 2007
- Phase
- Interventional
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of CF based on the following: sweat chloride > 60 mEq/L (by quantitative pilocarpine iontophoresis), or genotype with 2 identifiable mutations consistent with CF; and one or more clinical features consistent with CF.
- Age ≥ 14 years (changed from ≥ 18 years by protocol amendment).
- Able to expectorate sputum at screening.
- History of persistent positivity for P. aeruginosa on respiratory culture (at least three positive oropharyngeal (OP), sputum and/or bronchoscopy cultures in the 24 months prior to screening).
- Able to reproducibly perform pulmonary function testing.
- Clinically stable at screening, with no evidence of pulmonary exacerbation.
- Written informed consent provided.
Who cannot join
- Sputum culture negative for P. aeruginosa or density less than 10E5 CFU/gm at screening.
- Sputum culture positive for B. cepacia at screening.
- Presence of P. aeruginosa in sputum with off-scale resistance to all antibiotics by either method of susceptibility testing at screening. (changed from multiply-resistant P. aeruginosa by protocol amendment)
- History of B. cepacia positive respiratory culture within 24 months prior to screening.
- Hospitalization or treatment for a pulmonary exacerbation within 2 months prior to screening.
- Administration of parenteral anti-pseudomonal antibiotics within 2 months prior to screening.
Show all 16Show fewer
- Treatment with oral or inhaled anti-pseudomonal antibiotics, or azithromycin or other macrolides within 14 days prior to screening.
- History of allergy (urticarial rash, diffuse erythroderma, serum sickness) to more than two groups of antibiotics (aminoglycosides, penicillins, cephalosporins, monobactams, macrolides, or quinolones) that are a therapeutic option.
- History of anaphylaxis or other life threatening complication to any antibiotic in the six groups that are a therapeutic option.
- History of abnormal renal function (serum creatinine > 1.5 x upper limit of normal) within one year of enrollment.
- History of abnormal liver function tests (> 2.5 x upper limit of normal) within one year of enrollment.
- Clinically documented hearing loss that precludes treatment with aminoglycosides.
- Post lung transplantation.
- Positive pregnancy test or female who is lactating or is not practicing an acceptable method of birth control.
- Presence of a condition or abnormality that in the opinion of an investigator would compromise the safety of the patient or the quality of the data.
- Administration of any investigational agent within 30 days prior to screening.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Cincinnati
Cincinnati, Ohio, 45267-0557
Ohio State University
Columbus, Ohio, 43205
Baylor College of Medicine
Houston, Texas, 77030
University of Iowa
Iowa City, Iowa, 52242
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Children's Hospital and Regional Medical Center
Seattle, Washington, 98105-0371
University of Washington Medical Center
Seattle, Washington, 98195
Washington University St. Louis
St Louis, Missouri, 63110
About this study
Official title: Standard vs. Biofilm Susceptibility Testing in CF
This was a randomized multi-center clinical trial to compare the microbiological efficacy, clinical efficacy, and safety of using standard versus biofilm susceptibility testing of P. aeruginosa sputum isolates to guide antibiotic selection for treatment of airway infection in clinically stable patients with CF.
Read the detailed description
Patients were screened to determine eligibility and to obtain a sputum culture. Eligible patients were randomized to either the standard or biofilm study arm. Antibiotic selection was performed centrally according to a standard algorithm using the susceptibility test results of the assigned study arm. On Day 0, patients were started on a 14-day course of two antibiotics as selected per protocol. Antibiotics were administered intravenously (IV) and/or orally. A follow-up phone call or visit occurred on Day 7. An end of treatment visit was conducted after completion of antibiotic therapy. A total of 39 patients were randomized. Many screened patients were ineligible for randomization based on microbiology results.
- Conditions
- Cystic Fibrosis, Chronic Bronchitis
- Being tested
- IV amikacin, PO azithromycin, IV ceftazidime, PO ciprofloxacin, IV meropenem
- Keywords
- Cystic fibrosis, Antibiotic susceptibility testing, Pseudomonas aeruginosa, Chronic bronchitis, Biofilms
- Medical subject headings
- Cystic Fibrosis, Bronchitis, Chronic, Pseudomonas Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV amikacinDrug
5-7.5 mg/kg every 8 hrs or previous dose; start at previous recent stable dose then monitor serum levels and adjust dose, if needed, per standard clinical practice at the site
PO azithromycinDrug
250 mg once daily
IV ceftazidimeDrug
50 mg/kg every 8 hours, up to 2 grams every 8 hours
PO ciprofloxacinDrug
500 mg every 12 hours if weight <50 kg 750 mg every 12 hours if weight ≥50 kg
IV meropenemDrug
40 mg/kg every 8 hours, up to 2 grams every 8 hours
IV piperacillin-tazobactamDrug
100 mg/kg of piperacillin component every 6 hours, up to 3 grams every 6 hours; antibiotic combination formulated in a fixed ratio, thus dosing is described for first component only
IV ticarcillin-clavulanateDrug
100 mg/kg of ticarcillin component every 6 hours, up to 3 grams every 6 hours; antibiotic combination formulated in a fixed ratio, thus dosing is described for first component only
IV tobramycinDrug
2.5-3.3 mg/kg every 8 hrs or previous dose; start at previous recent stable dose then monitor serum levels and adjust dose, if needed, per standard clinical practice at the site
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Antibiotic regimen assignment based on biofilm susceptibility test results Receives: Drug: IV amikacin; Drug: PO azithromycin; Drug: IV ceftazidime; Drug: PO ciprofloxacin; Drug: IV meropenem; Drug: IV piperacillin-tazobactam; Drug: IV ticarcillin-clavulanate; Drug: IV tobramycin |
| 2 | Active comparator | Antibiotic regimen assignment based on conventional susceptibility test results Receives: Drug: IV amikacin; Drug: PO azithromycin; Drug: IV ceftazidime; Drug: PO ciprofloxacin; Drug: IV meropenem; Drug: IV piperacillin-tazobactam; Drug: IV ticarcillin-clavulanate; Drug: IV tobramycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiological efficacy: Change in P. aeruginosa density
Measured: from enrollment (up to day -21) to end of treatment (day 12-14)
Secondary outcomes (3)
Clinical efficacy: Pre- to post-treatment change in FEV1
Measured: from initiation (day 0) to end of treatment (day 12-14)
Safety: Adverse events, including new onset of acute pulmonary exacerbation and/or the need to change antibiotic therapy during the treatment period
Measured: from enrollment (up to day -21) to end of treatment (day 12-14)
Feasibility: Average costs and time per assay; rate of patient withdrawal because resistance patterns preclude randomization; self-reported technician satisfaction
Measured: during active enrollment (March 2004-November 2007)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startMar 2004
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Investigators
- Samuel M Moskowitz, MD, Principal investigator, Seattle Children's HospitalJane L Burns, MD, Study chair, Children's Hospital and Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00153634
- Sponsor's protocol ID
- BURNS03A0
- Status last verified
- Nov 2007
- First submitted
- 8 Sep 2005
- Last updated
- 13 Mar 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Moskowitz SM, Foster JM, Emerson J, Burns JL. Clinically feasible biofilm susceptibility assay for isolates of Pseudomonas aeruginosa from patients with cystic fibrosis. J Clin Microbiol. 2004 May;42(5):1915-22. doi: 10.1128/JCM.42.5.1915-1922.2004.
PubMed 15131149Moskowitz SM, Foster JM, Emerson JC, Gibson RL, Burns JL. Use of Pseudomonas biofilm susceptibilities to assign simulated antibiotic regimens for cystic fibrosis airway infection. J Antimicrob Chemother. 2005 Nov;56(5):879-86. doi: 10.1093/jac/dki338. Epub 2005 Sep 27.
PubMed 16188918
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard vs. Biofilm Susceptibility Testing in CF
- ClinicalTrials.gov ID
- NCT00153634
- Acronym / sponsor ID
- BURNS03A0
- Conditions
- Cystic Fibrosis, Chronic Bronchitis
- Keywords
- Cystic fibrosis, Antibiotic susceptibility testing, Pseudomonas aeruginosa, Chronic bronchitis, Biofilms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Study start
- Mar 2004
- Study completion
- Nov 2007 (actual)
- First posted
- 12 Sep 2005 (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 was a randomized multi-center clinical trial to compare the microbiological efficacy, clinical efficacy, and safety of using standard versus biofilm susceptibility testing of P. aeruginosa sputum isolates to guide antibiotic selection for treatment of airway infection in clinically stable patients with CF.
Detailed description
Patients were screened to determine eligibility and to obtain a sputum culture. Eligible patients were randomized to either the standard or biofilm study arm. Antibiotic selection was performed centrally according to a standard algorithm using the susceptibility test results of the assigned study arm. On Day 0, patients were started on a 14-day course of two antibiotics as selected per protocol. Antibiotics were administered intravenously (IV) and/or orally. A follow-up phone call or visit occurred on Day 7. An end of treatment visit was conducted after completion of antibiotic therapy. A total of 39 patients were randomized. Many screened patients were ineligible for randomization based on microbiology results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: IV amikacin, Drug: PO azithromycin, Drug: IV ceftazidime, Drug: PO ciprofloxacin, Drug: IV meropenem, Drug: IV piperacillin-tazobactam, Drug: IV ticarcillin-clavulanate, Drug: IV tobramycinAntibiotic regimen assignment based on biofilm susceptibility test results |
| 2 | Active comparator | Drug: IV amikacin, Drug: PO azithromycin, Drug: IV ceftazidime, Drug: PO ciprofloxacin, Drug: IV meropenem, Drug: IV piperacillin-tazobactam, Drug: IV ticarcillin-clavulanate, Drug: IV tobramycinAntibiotic regimen assignment based on conventional susceptibility test results |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of CF based on the following: sweat chloride > 60 mEq/L (by quantitative pilocarpine iontophoresis), or genotype with 2 identifiable mutations consistent with CF; and one or more clinical features consistent with CF.
- Age ≥ 14 years (changed from ≥ 18 years by protocol amendment).
- Able to expectorate sputum at screening.
- History of persistent positivity for P. aeruginosa on respiratory culture (at least three positive oropharyngeal (OP), sputum and/or bronchoscopy cultures in the 24 months prior to screening).
- Able to reproducibly perform pulmonary function testing.
Key exclusion criteria (16 listed)
- Sputum culture negative for P. aeruginosa or density less than 10E5 CFU/gm at screening.
- Sputum culture positive for B. cepacia at screening.
- Presence of P. aeruginosa in sputum with off-scale resistance to all antibiotics by either method of susceptibility testing at screening. (changed from multiply-resistant P. aeruginosa by protocol amendment)
- History of B. cepacia positive respiratory culture within 24 months prior to screening.
- Hospitalization or treatment for a pulmonary exacerbation within 2 months prior to screening.
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 |
|---|---|---|
| IV amikacin5-7.5 mg/kg every 8 hrs or previous dose; start at previous recent stable dose then monitor serum levels and adjust dose, if needed, per standard clinical practice at the site | Drug | 1, 2 |
| PO azithromycin250 mg once daily | Drug | 1, 2 |
| IV ceftazidime50 mg/kg every 8 hours, up to 2 grams every 8 hours | Drug | 1, 2 |
| PO ciprofloxacin500 mg every 12 hours if weight <50 kg 750 mg every 12 hours if weight ≥50 kg | Drug | 1, 2 |
| IV meropenem40 mg/kg every 8 hours, up to 2 grams every 8 hours | Drug | 1, 2 |
| IV piperacillin-tazobactam100 mg/kg of piperacillin component every 6 hours, up to 3 grams every 6 hours; antibiotic combination formulated in a fixed ratio, thus dosing is described for first component only | Drug | 1, 2 |
| IV ticarcillin-clavulanate100 mg/kg of ticarcillin component every 6 hours, up to 3 grams every 6 hours; antibiotic combination formulated in a fixed ratio, thus dosing is described for first component only | Drug | 1, 2 |
| IV tobramycin2.5-3.3 mg/kg every 8 hrs or previous dose; start at previous recent stable dose then monitor serum levels and adjust dose, if needed, per standard clinical practice at the site | Drug | 1, 2 |
Primary outcome
Microbiological efficacy: Change in P. aeruginosa density
Time frame: from enrollment (up to day -21) to end of treatment (day 12-14)
3 secondary outcomes
Clinical efficacy: Pre- to post-treatment change in FEV1
Time frame: from initiation (day 0) to end of treatment (day 12-14)
Safety: Adverse events, including new onset of acute pulmonary exacerbation and/or the need to change antibiotic therapy during the treatment period
Time frame: from enrollment (up to day -21) to end of treatment (day 12-14)
Feasibility: Average costs and time per assay; rate of patient withdrawal because resistance patterns preclude randomization; self-reported technician satisfaction
Time frame: during active enrollment (March 2004-November 2007)
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 13 Mar 2008.
- Background: PubMed 15131149Moskowitz SM, Foster JM, Emerson J, Burns JL. Clinically feasible biofilm susceptibility assay for isolates of Pseudomonas aeruginosa from patients with cystic fibrosis. J Clin Microbiol. 2004 May;42(5):1915-22. doi: 10.1128/JCM.42.5.1915-1922.2004.
- Background: PubMed 16188918Moskowitz SM, Foster JM, Emerson JC, Gibson RL, Burns JL. Use of Pseudomonas biofilm susceptibilities to assign simulated antibiotic regimens for cystic fibrosis airway infection. J Antimicrob Chemother. 2005 Nov;56(5):879-86. doi: 10.1093/jac/dki338. Epub 2005 Sep 27.
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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.
Samuel M Moskowitz, MD principal investigator
Seattle Children's Hospital
Jane L Burns, MD study chair
Children's Hospital and Regional Medical Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IV amikacin, PO azithromycin and IV ceftazidime in people with Cystic Fibrosis and Chronic Bronchitis, run by Seattle Children's Hospital at 8 sites in United States.
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 7 inclusion and 16 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 13 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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.
What does the primary outcome measure?
Microbiological efficacy: Change in P. aeruginosa density (time frame: from enrollment (up to day -21) to end of treatment (day 12-14)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00153634, which also lists 2 linked publications.
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 13 Mar 2008.