Cystic FibrosisPhase 4NCT01044719
Duration of Antibiotics in Infective Exacerbations of Cystic Fibrosis
A Phase 4 study testing Ceftazidime, Tobramycin and Meropenem in people with Cystic Fibrosis, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Cystic Fibrosis patients attending with infective exacerbations will be enrolled into the study. The trial is a double blinded, randomised trial with patients randomised to 10,14 or 21 days of antibiotic therapy, comprising of tobramycin and either ceftazidime or meropenem. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Ceftazidime, Tobramycin and Meropenem
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2010to Apr 2011
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 16 years or older
- Diagnosis of Cystic Fibrosis
- Presenting with Infective exacerbation
Who cannot join
- Unable to give consent
- Allergy to study medications
- Intolerance of aminoglycoside antibiotics
- Pseudomonas resistant to study antibiotics
- On the active transplant list or FEV1<20% predicted
- Pregnancy/breast-feeding
Show all 9Show fewer
- Co-existent ABPA requiring a change in treatment
- Co-existent mycobacterial infection
- A previous participant in the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Cystic Fibrosis, Royal Brompton Hospital
London, Sw3 6NP
About this study
Official title: What Duration of Intravenous Antibiotic Therapy Should be Used in the Treatment of Infective Exacerbations of Cystic Fibrosis Chronically Colonised With Pseudomonas Aeruginosa
Cystic Fibrosis patients attending with infective exacerbations will be enrolled into the study. The trial is a double blinded, randomised trial with patients randomised to 10,14 or 21 days of antibiotic therapy, comprising of tobramycin and either ceftazidime or meropenem.
- Conditions
- Cystic Fibrosis
- Being tested
- Ceftazidime, Tobramycin, Meropenem
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeftazidimeDrug
Ceftazidime 2g TDS IV
TobramycinDrug
Tobramycin 7mg/kg/day OD IV
MeropenemDrug
Meropenem 2g TDS IV
| Study group | Role | What they receive |
|---|---|---|
| 10 days | Active comparator | Not described Receives: Drug: Ceftazidime; Drug: Tobramycin; Drug: Meropenem |
| 14 days | Active comparator | Not described Receives: Drug: Ceftazidime; Drug: Tobramycin; Drug: Meropenem |
| 21 days | Active comparator | Not described Receives: Drug: Ceftazidime; Drug: Tobramycin; Drug: Meropenem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure at completion of antibiotic course
Measured: 21 days
Time to next exacerbation
Measured: 6 months
Secondary outcomes (6)
Change in Spirometry
Measured: up to 21 days
Change in inflammatory markers
Measured: up to 21 days
Change in sputum bacteriology
Measured: up to 21 days
Adverse effects of study antibiotics
Measured: Up to 21 days
Quality of life scores
Measured: Up to 21 days
Change in nutritional status
Measured: up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionOct 2010 (estimated)
- Study completionApr 2011 (estimated)
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 Imperial College LondonThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Investigators
- Margaret Hodson, MD FRCP DA, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01044719
- Sponsor's protocol ID
- RBHADS001
- Status last verified
- Apr 2010
- First submitted
- 14 Dec 2009
- Last updated
- 13 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Duration of Intravenous Antibiotic Therapy Should be Used in the Treatment of Infective Exacerbations of Cystic Fibrosis Chronically Colonised With Pseudomonas Aeruginosa
- ClinicalTrials.gov ID
- NCT01044719
- Acronym / sponsor ID
- RBHADS001
- Conditions
- Cystic Fibrosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Oct 2010 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 8 Jan 2010 (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.
Cystic Fibrosis patients attending with infective exacerbations will be enrolled into the study. The trial is a double blinded, randomised trial with patients randomised to 10,14 or 21 days of antibiotic therapy, comprising of tobramycin and either ceftazidime or meropenem.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 10 days | Active comparator | Drug: Ceftazidime, Drug: Tobramycin, Drug: Meropenem |
| 14 days | Active comparator | Drug: Ceftazidime, Drug: Tobramycin, Drug: Meropenem |
| 21 days | Active comparator | Drug: Ceftazidime, Drug: Tobramycin, Drug: Meropenem |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 16 years or older
- Diagnosis of Cystic Fibrosis
- Presenting with Infective exacerbation
Key exclusion criteria (9 listed)
- Unable to give consent
- Allergy to study medications
- Intolerance of aminoglycoside antibiotics
- Pseudomonas resistant to study antibiotics
- On the active transplant list or FEV1<20% predicted
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 |
|---|---|---|
| CeftazidimeCeftazidime 2g TDS IV | Drug | 10 days, 14 days, 21 days |
| TobramycinTobramycin 7mg/kg/day OD IV | Drug | 10 days, 14 days, 21 days |
| MeropenemMeropenem 2g TDS IV | Drug | 10 days, 14 days, 21 days |
Primary outcome
Treatment failure at completion of antibiotic course
Time frame: 21 days
Time to next exacerbation
Time frame: 6 months
6 secondary outcomes
Change in Spirometry
Time frame: up to 21 days
Change in inflammatory markers
Time frame: up to 21 days
Change in sputum bacteriology
Time frame: up to 21 days
Adverse effects of study antibiotics
Time frame: Up to 21 days
Quality of life scores
Time frame: Up to 21 days
Change in nutritional status
Time frame: up to 21 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2010.
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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.
Margaret Hodson, MD FRCP DA principal investigator
Imperial College London
1 site 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, Tobramycin and Meropenem in people with Cystic Fibrosis, run by Imperial College London at 1 site in United Kingdom.
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 3 inclusion and 9 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 13 Apr 2010. 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 United Kingdom. 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?
Contact Andrew Jones, MB BChir MRCP (02073518940, andrew.jones1@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment failure at completion of antibiotic course (time frame: 21 days). The study lists 2 primary outcomes in all. 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 13 Apr 2010.