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Cystic FibrosisPhase 4CISTICNCT01667094

A Study Comparing Continuous Infusion Antibiotics to Standard Treatment for Lung Infections in Cystic Fibrosis

A Phase 4 study testing Intermittent, short infusion Ceftazidime, Continuous infusion Ceftazidime and Intermittent, short infusion Meropenem in people with Cystic Fibrosis, run by The Alfred at 1 site in Australia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Cystic fibrosis (CF) is an inherited disorder which results in increased thickness of secretions, especially in the lungs. By adulthood, the majority of patients with CF will have a bacteria living in their lungs, called Pseudomonas aeruginosa which can cause lung infections. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cystic Fibrosis
What is being tested?
Intermittent, short infusion Ceftazidime, Continuous infusion Ceftazidime and Intermittent, short infusion Meropenem
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteAustralia
Study dates
Sep 2012to Jul 2017
Phase
Phase 4
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients >= 18 years of age,
  • Pseudomonas aeruginosa isolated in sputum within the last 12 months,
  • has an acute infective exacerbation, defined by international standards of 2 or more of the following in the last 2 weeks:
  • change sputum volume or colour,
  • increased cough,
  • increased dyspnoea,
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  • increased malaise, fatigue or lethargy,
  • anorexia or weight loss,
  • decrease in pulmonary function by 10% or more, or
  • new radiographic changes

Who cannot join

  • patients < 18 yrs of age,
  • patients that do not meet the criteria for an acute infective exacerbation,
  • concurrent pulmonary embolism, significant haemoptysis, pneumothorax, or respiratory failure,
  • impaired renal function with an estimated creatinine clearance < 60 mls/min,
  • patients allergic to ß-lactam antibiotics,
  • aminoglycoside contra-indicated,
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  • intravenous antibiotics in the last 2 weeks, prior to this admission,
  • received more than 24 hours of intravenous antibiotics in this admission,
  • previous lung transplantation,
  • pregnancy or lactation, or
  • inability to consent.

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • The Alfred Hospital

    Melbourne, Victoria, 3181

Other trials in Australia

About this study

Official title: Continuous-infusion Anti-pseudomonal β-lactams for the Treatment of Acute, Infective Pulmonary Exacerbations in Cystic Fibrosis

Cystic fibrosis (CF) is an inherited disorder which results in increased thickness of secretions, especially in the lungs. By adulthood, the majority of patients with CF will have a bacteria living in their lungs, called Pseudomonas aeruginosa which can cause lung infections. This usually results in worsening respiratory symptoms and often an acute deterioration in their lung function. They are usually treated with antibiotics that target the Pseudomonas aeruginosa. These antibiotics are typically given as short intravenous infusions several times a day. This study aims to compare the standard method of giving these antibiotics with a different strategy of giving these antibiotics to see if this can improve the outcomes of treatment of these infections and reduce the amount of Pseudomonas aeruginosa in the lungs of these patients. This strategy consists of giving the same antibiotics continuously, to ensure there is always enough antibiotic in the bloodstream and the lung to be able to kill the bacteria.

Conditions
Cystic Fibrosis
Being tested
Intermittent, short infusion Ceftazidime, Continuous infusion Ceftazidime, Intermittent, short infusion Meropenem, Continuous infusion Meropenem, Intermittent, short infusion Ticarcillin-clavulanate
Keywords
Pulmonary exacerbation, Continuous infusion, Antipseudomonal beta-lactams
Medical subject headings
Cystic Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intermittent, short infusion CeftazidimeDrug

    Ceftazidime 1g q8/24

  • Continuous infusion CeftazidimeDrug

    Ceftazidime loading dose 1g infused over 30mins then 3g infused over 12h q12/24

  • Intermittent, short infusion MeropenemDrug

    Meropenem 1g q8/24, infusion over 30 minutes

  • Continuous infusion MeropenemDrug

    Meropenem initial loading dose of 500mg infused over 30 minutes followed by 1.5g infused over 12/24, q12/24

  • Intermittent, short infusion Ticarcillin-clavulanateDrug

    Ticarcillin/clavulanate 3.1g q6/24

  • Continuous infusion Ticarcillin-clavulanateDrug

    Ticarcillin-clavulanate loading dose 1.55g followed by 12.4g infused over 24/24 q24/24

  • Intermittent, short infusion CefepimeDrug

    Cefepime 1g q8/24

  • Continuous infusion CefepimeDrug

    Cefepime loading dose 500mg followed by 1.5g infused over 12/24, q12/24

  • Continuous infusion Piperacillin tazobactamDrug

    Piperacillin tazobactam loading dose of 4.5g infused over 30 minutes followed by 18g infused over 24/24, q24/24

  • Intermittent, short infusion Piperacillin tazobactamDrug

    Piperacillin tazobactam 4.5g q6/24

Study groups in NCT01667094
Study groupRoleWhat they receive
Intermittent, short infusionActive comparatorInfusion over 30 minutes of either: Cefepime 1g q8/24 OR Ceftazidime 2g q8/24 OR Meropenem 1g q8/24 OR Piperacillin-Tazobactam 4.5g q8/24 OR Ticarcillin-clavulanate 3.1g q6/24 Antibiotic chosen by treating physician
Receives: Drug: Intermittent, short infusion Ceftazidime; Drug: Intermittent, short infusion Meropenem; Drug: Intermittent, short infusion Ticarcillin-clavulanate; Drug: Intermittent, short infusion Cefepime; Drug: Intermittent, short infusion Piperacillin tazobactam
Continuous infusionExperimentalContinuous infusion of either: Cefepime 1.5g over 12h, q12/24 after initial loading dose of 500mg OR Ceftazidime 3g over 12h, q12/24 after initial loading dose 1g OR Meropenem 1.5g over 12h, q12/24 after initial loading dose 500mg OR Piperacillin-tazobactam 13.5g over 24h after initial loading dose 2.25g OR Ticarcillin-clavulanate 12.4g over 24h after initial loading dose 1.55g Antibiotic chosen by treating physician
Receives: Drug: Continuous infusion Ceftazidime; Drug: Continuous infusion Meropenem; Drug: Continuous infusion Ticarcillin-clavulanate; Drug: Continuous infusion Cefepime; Drug: Continuous infusion Piperacillin tazobactam

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cystic Fibrosis Questionnaire-Revised respiratory component (CFQ-R) respiratory symptom score

    Measured: Day 0 to Day 14

Secondary outcomes (7)

  1. Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) respiratory symptom score

    Measured: Day 0 to Day 7, Day 0 to Day 28

  2. Lung function testing; Forced volume expired in one second (FEV1)

    Measured: Day 0 to Day 7, Day 0 to Day 28

  3. C-reactive peptide (CRP)

    Measured: Day 0 to Day 3

  4. Quantitative bacterial load in sputum (total + Pseudomonas aeruginosa)

    Measured by PCR.

    Measured: Day 0 to Day 3, Day 0 to Day 7

  5. Time above minimum inhibitory concentration (MIC)

    Measured: Day 3

  6. Antibiotic stability

    For ceftazidime and meropenem, antibiotic levels will be measured from the infusion bag at the beginning and end of the infusion to determine the amount of degradation of these antibiotics.

    The temperature of the infusion bags will be monitored continuously during this time.

    Measured: Day 3

  7. Pseudomonas aeruginosa virulence gene determinants

    A panel of different previously identified virulence gene determinants for Pseudomonas aeruginosa will be measured by RNA analysis.

    Measured: Day 0 to Day 3 and Day 0 to Day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionJul 2017 (estimated)
  4. Study completionJul 2017 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01667094
Sponsor's protocol ID
249/12
Other IDs
U1111-1132-8291
Acronym
CISTIC
Status last verified
Apr 2017
First submitted
13 Aug 2012
Last updated
20 Apr 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Intermittent, short infusion Ceftazidime, Continuous infusion Ceftazidime and Intermittent, short infusion Meropenem in people with Cystic Fibrosis, run by The Alfred at 1 site in Australia.

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 10 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

Cystic Fibrosis Questionnaire-Revised respiratory component (CFQ-R) respiratory symptom score (time frame: Day 0 to Day 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 NCT01667094.

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 20 Apr 2017.

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