Cystic FibrosisPhase 4NCT00333385
Continuous Versus Short Infusions of Ceftazidime in Cystic Fibrosis
A Phase 4 study testing ceftazidime in people with Cystic Fibrosis and Pseudomonas Aeruginosa, run by Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche at 15 sites in France.
Trial summary
The aim of this trial was to compare the safety and efficacy of courses of tobramycin and ceftazidime, administered intravenously as either thrice daily short infusions or 24 h continuous infusion, in cystic fibrosis patients with acute exacerbation of chronic pulmonary PA infection. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Cystic Fibrosis, Pseudomonas Aeruginosa, Pulmonary Exacerbation
- What is being tested?
- ceftazidime
- How many people
- 120 participants
- Where
- 15 sitesFrance
- Study dates
- Oct 2001to Apr 2004
- 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 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with cystic fibrosis older than 8 years
- with chronic Pseudomonas aeruginosa infection of the respiratory tract
- with at least 2 courses of IV antibiotic in the year before enrolment
- at the time of a pulmonary exacerbation
Who cannot join
- allergy to ceftazidime or tobramycin
- bronchial colonization with Burkholderia cepacia
- renal impairment
- history of lung transplantation
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
France15 sites
CHU Grenoble
Grenoble, 38043
Centre hospitalier Dr Schaffner
Lens, 62307
Hopital Albert Calmette
Lille, 59000
Hopital Jeanne de Flandre
Lille, 59000
Hopital Sainte Marguerite
Marseille, 13000
Assistance Publique des hopitaux de paris, Hopital Trousseau
Paris, 75012
Assistance Publique des Hopitaux de Paris, Hopital Cochin
Paris, 75014
Assistance Publique des Hopitaux de Paris, Hopital Necker
Paris, 75015
Assistance Publique des Hopitaux de Paris, Hopital Robert Debré
Paris, 75019
Hopital Sud
Rennes, 35056
Centre Héliomarin
Roscoff, 29684
Hopital Hautepierre
Strasbourg, 67000
Hopital Foch
Suresnes, 92150
Hopital Larrey
Toulouse, 31000
Hopital de Brabois
Vandœuvre-lès-Nancy, 54511
About this study
The aim of this trial was to compare the safety and efficacy of courses of tobramycin and ceftazidime, administered intravenously as either thrice daily short infusions or 24 h continuous infusion, in cystic fibrosis patients with acute exacerbation of chronic pulmonary PA infection. In conventional treatment regimens, ceftazidime is administered in the form of thrice daily short infusions, but pharmacodynamic considerations suggest that continuous infusion could be more effective.
Read the detailed description
Each patient received two successive IV antibiotic courses during a period of pulmonary exacerbation. One of these courses was delivered as thrice daily 30-minute infusions of ceftazidime in 100 ml of 0.9% sodium chloride, and the other was delivered as a continuous infusion of ceftazidime in 230 ml of 0.9% sodium chloride, over 23 hours. The daily dose of ceftazidime was 200 mg/kg, with a maximum dose of 12 g. For ceftazidime continuous infusion, a loading dose of 60 mg/kg (maximum 2 g) was used. All patients also received tobramycin (10 mg/kg), in the form of one 30-minute infusion per day. Portable devices were used: Intermate® SV 200 (Baxter) for the 30-minute short infusions of ceftazidime and tobramycin, Infusor® LV10 (Baxter) for continuous infusion of ceftazidime.
- Being tested
- ceftazidime
- Keywords
- Ceftazidime, Continuous infusion, Antibiotic course
- Medical subject headings
- Cystic Fibrosis, Pseudomonas Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ceftazidimeDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in forced expiratory volume in 1s (FEV1) between the beginning and the end of the IV antibiotic course, expressed as a percentage of the predicted normal value
Secondary outcomes (5)
the interval between 2 successive IV antibiotic courses
quality of life scores
sputum collected at the beginning and the end of each antibiotic course
plasma ceftazidime concentration at steady state (Css) for ceftazidime continuous infusion, and before (C trough), 30 minutes (Cmax) and 4 hours after (C4) the beginning of ceftazidime short infusion
C-reactive protein, leukocytes and hepatic enzymes levels at the beginning and the end of each IV antibiotic course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2006 (estimated)
- Study startOct 2001
- Study completionApr 2004
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
- Sponsor type
- University, hospital or other
- Collaborators
- Vaincre la Mucoviscidose, GlaxoSmithKline, Baxter Healthcare Corporation, Roche Pharma AG
- Investigators
- Dominique Hubert, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00333385
- Sponsor's protocol ID
- 01648
- Status last verified
- Mar 2001
- First submitted
- 2 Jun 2006
- Last updated
- 5 Jun 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Versus Short Infusions of Ceftazidime in Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT00333385
- Acronym / sponsor ID
- 01648
- Keywords
- Ceftazidime, Continuous infusion, Antibiotic course
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 120 participants
- Lead sponsor
- Association Nationale pour les Traitements A Domicile, les Innovations et la RechercheUniversity, hospital or other
- Collaborators
- Vaincre la Mucoviscidose, GlaxoSmithKline, Baxter Healthcare Corporation, Roche Pharma AG
- Study start
- Oct 2001
- Study completion
- Apr 2004
- First posted
- 5 Jun 2006 (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.
The aim of this trial was to compare the safety and efficacy of courses of tobramycin and ceftazidime, administered intravenously as either thrice daily short infusions or 24 h continuous infusion, in cystic fibrosis patients with acute exacerbation of chronic pulmonary PA infection. In conventional treatment regimens, ceftazidime is administered in the form of thrice daily short infusions, but pharmacodynamic considerations suggest that continuous infusion could be more effective.
Detailed description
Each patient received two successive IV antibiotic courses during a period of pulmonary exacerbation. One of these courses was delivered as thrice daily 30-minute infusions of ceftazidime in 100 ml of 0.9% sodium chloride, and the other was delivered as a continuous infusion of ceftazidime in 230 ml of 0.9% sodium chloride, over 23 hours. The daily dose of ceftazidime was 200 mg/kg, with a maximum dose of 12 g. For ceftazidime continuous infusion, a loading dose of 60 mg/kg (maximum 2 g) was used. All patients also received tobramycin (10 mg/kg), in the form of one 30-minute infusion per day. Portable devices were used: Intermate® SV 200 (Baxter) for the 30-minute short infusions of ceftazidime and tobramycin, Infusor® LV10 (Baxter) for continuous infusion of ceftazidime.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- patients with cystic fibrosis older than 8 years
- with chronic Pseudomonas aeruginosa infection of the respiratory tract
- with at least 2 courses of IV antibiotic in the year before enrolment
- at the time of a pulmonary exacerbation
Key exclusion criteria (4 listed)
- allergy to ceftazidime or tobramycin
- bronchial colonization with Burkholderia cepacia
- renal impairment
- history of lung transplantation
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 | Drug | – |
Primary outcome
Change in forced expiratory volume in 1s (FEV1) between the beginning and the end of the IV antibiotic course, expressed as a percentage of the predicted normal value
5 secondary outcomes
the interval between 2 successive IV antibiotic courses
quality of life scores
sputum collected at the beginning and the end of each antibiotic course
plasma ceftazidime concentration at steady state (Css) for ceftazidime continuous infusion, and before (C trough), 30 minutes (Cmax) and 4 hours after (C4) the beginning of ceftazidime short infusion
C-reactive protein, leukocytes and hepatic enzymes levels at the beginning and the end of each IV antibiotic course
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2006.
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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.
Dominique Hubert, MD principal investigator
Assistance Publique - Hôpitaux de Paris
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ceftazidime in people with Cystic Fibrosis and Pseudomonas Aeruginosa, run by Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche at 15 sites in France.
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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 5 Jun 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France. 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?
The study was stopped early. 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?
Change in forced expiratory volume in 1s (FEV1) between the beginning and the end of the IV antibiotic course, expressed as a percentage of the predicted normal value. It is what the study was designed to measure, not a finding.
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 5 Jun 2006.