Cystic FibrosisPhase 4CCTOBINCT01400750
Comparison of 2 Treatment Regimens for Eradication of P Aeruginosa Infection in Children With Cystic Fibrosis
A Phase 4 study testing oral ciprofloxacin plus inhaled colistin and TOBI in people with Cystic Fibrosis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Treatment of new Pseudomonas aeruginosa (Pa) infection in cystic fibrosis (CF) can postpone chronic infection. Aim of the study: compare 2 Pa eradication regimens in children with new Pa infection. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- oral ciprofloxacin plus inhaled colistin and TOBI
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2001to May 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- diagnosis of CF (clinical signs consistent with CF and a sweat chloride > 60 mEq/l by quantitative pilocarpine iontophoresis and/or two CF causing mutations identified)
- age 0 to 18 years old at time of inclusion
- 'First' or 'new Pa infection' defined as 'first Pa isolation ever' or 'isolation of Pa from the airway (sputum, throat swab or BAL) after a Pa free interval of at least 6 months and documented with at least 3 negative cultures'.
Who cannot join
- chronic Pa infection defined according to the Leeds criteria[17]
- pulmonary exacerbation needing IV AB treatment at time of new Pa isolate
- Pa isolation at time of CF diagnosis
- patient already on an antipseudomonal antibiotic
- interval between positive culture and start of treatment > 4 weeks.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Department of pediatrics, CF center Uuiversity Hospital Leuven
Leuven, 3000
About this study
Official title: Prospective Randomized Trial Comparing Oral Ciproxin Plus Inhaled Colistin With Tobramycin for Inhalation for Eradication of P Aeruginosa Infection in Children With Cystic Fibrosis.
Treatment of new Pseudomonas aeruginosa (Pa) infection in cystic fibrosis (CF) can postpone chronic infection. Aim of the study: compare 2 Pa eradication regimens in children with new Pa infection.
Read the detailed description
Methods: CF children (0-18 years) with a new isolation of Pa from the airway were randomized to tobramycin inhalation solution (TOBI® 2x300 mg for 28 days) (TIS) or inhaled colistimethate sodium (Colistineb® 2x2 mill U daily) plus oral ciprofloxacin (30mg/kg/day) for 3 months (CC). The primary outcome was eradication at end of treatment. Secondary outcome parameters were time to Pa relapse, total and Pa specific IgG, FEV1, BMI and Pa status.
- Conditions
- Cystic Fibrosis
- Being tested
- oral ciprofloxacin plus inhaled colistin, TOBI
- Keywords
- cystic fibrosis- P aeruginosa- eradication-child
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral ciprofloxacin plus inhaled colistinDrug
Also called Ciproxin ® - ciprofloxacin, Colistineb ®
oral ciprofloxacin (30mg/kg/day divided in 2 doses) for 3 months (CC) plus inhaled colistimethate sodium(Colistineb® 2x2 mill U daily)
TOBIDrug
Also called TOBI® - tobramycin inhalation solution (TIS)
tobramycin inhalation solution (TOBI® 2x300 mg) for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Ciproxin-inhaled Colistin | Active comparator | oral ciprofloxacin (30mg/kg/day) plus inhaled colistimethate sodium (Colistineb® 2x2 mill U daily) for 3 months Receives: Drug: oral ciprofloxacin plus inhaled colistin |
| Tobramycine for inhalation (TIS) | Active comparator | tobramycin inhalation solution (TOBI® 2x300 mg) for 28 days Receives: Drug: TOBI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pseudomonas aeruginosa eradication at the end of the treatment.
sucessful eradication is defined as negative airway culture for P aeruginosa and end of study drug which is after 3 months for ciproxin-colistin (CC) and after 1 months for tobramycin for inhalation (TIS)
Measured: end of study drug treatment ie 3 months for CC and at 1 months for TIS
Secondary outcomes (6)
P aeruginosa eradication at 6 months after study entry
negative airway cultures for P aeruginosa up to 6 months after start of study drug
Measured: 6 months
time to new Pa positive culture (= relapse)
Time to first new P aeruginosa positive airway culture (expressed in months starting from end of study drug)
Measured: 1 year
change from baseline FEV1% pred, IgG z score, BMI z score was followed
Evolution of lung function (expressed as FEV1% pred), total IgG and nutritional status (expressed as BMI z score) from start of study up to 1 year
Measured: 1 year
Antibody titer for specific anti Pseudomonas antibodies
Pa antibodies (ELISA St Ag 1-17 )were measured at baseline and at 1 year follow-up
Measured: 1 year
P aeruginosa infection status
P aeruginosa infection status was reported as 'Free off', 'Intermittent' or 'Chronic' according to the Leeds criteria after 1 and 2 years.
(ref Leeds criteria: Lee TW, Brownlee KG, Conway SP, et al. Evaluation of a new definition for chronic Pseudomonas aeruginosa infection in cystic fibrosis patients. J Cyst Fibros 2003;2(1):29-34)
Measured: 1 year
P aeruginosa infection status
P aeruginosa infection status was reported as 'Free off', 'Intermittent' or 'Chronic' according to the Leeds criteria after 1 and 2 years.
(ref Leeds criteria: Lee TW, Brownlee KG, Conway SP, et al. Evaluation of a new definition for chronic Pseudomonas aeruginosa infection in cystic fibrosis patients. J Cyst Fibros 2003;2(1):29-34)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startAug 2001
- Primary completionAug 2010
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Universitaire Ziekenhuizen KU LeuvenThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Investigators
- Marijke J Proesmans, MD, PhD, Principal investigator, Dep pediatrics University Hospital Leuven Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01400750
- Sponsor's protocol ID
- MP1
- Acronym
- CCTOBI
- Status last verified
- Jul 2011
- First submitted
- 18 Jul 2011
- Last updated
- 4 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Langton Hewer SC, Smyth AR. Antibiotic strategies for eradicating Pseudomonas aeruginosa in people with cystic fibrosis. Cochrane Database Syst Rev. 2009 Oct 7;(4):CD004197. doi: 10.1002/14651858.CD004197.pub3.
PubMed 19821321
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial Comparing Oral Ciproxin Plus Inhaled Colistin With Tobramycin for Inhalation for Eradication of P Aeruginosa Infection in Children With Cystic Fibrosis.
- ClinicalTrials.gov ID
- NCT01400750
- Acronym / sponsor ID
- CCTOBI / MP1
- Conditions
- Cystic Fibrosis
- Keywords
- cystic fibrosis- P aeruginosa- eradication-child
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Aug 2001
- Primary completion
- Aug 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 22 Jul 2011 (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.
Treatment of new Pseudomonas aeruginosa (Pa) infection in cystic fibrosis (CF) can postpone chronic infection. Aim of the study: compare 2 Pa eradication regimens in children with new Pa infection.
Detailed description
Methods: CF children (0-18 years) with a new isolation of Pa from the airway were randomized to tobramycin inhalation solution (TOBI® 2x300 mg for 28 days) (TIS) or inhaled colistimethate sodium (Colistineb® 2x2 mill U daily) plus oral ciprofloxacin (30mg/kg/day) for 3 months (CC). The primary outcome was eradication at end of treatment. Secondary outcome parameters were time to Pa relapse, total and Pa specific IgG, FEV1, BMI and Pa status.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ciproxin-inhaled Colistin | Active comparator | Drug: oral ciprofloxacin plus inhaled colistinoral ciprofloxacin (30mg/kg/day) plus inhaled colistimethate sodium (Colistineb® 2x2 mill U daily) for 3 months |
| Tobramycine for inhalation (TIS) | Active comparator | Drug: TOBItobramycin inhalation solution (TOBI® 2x300 mg) for 28 days |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- diagnosis of CF (clinical signs consistent with CF and a sweat chloride > 60 mEq/l by quantitative pilocarpine iontophoresis and/or two CF causing mutations identified)
- age 0 to 18 years old at time of inclusion
- 'First' or 'new Pa infection' defined as 'first Pa isolation ever' or 'isolation of Pa from the airway (sputum, throat swab or BAL) after a Pa free interval of at least 6 months and documented with at least 3 negative cultures'.
Key exclusion criteria (5 listed)
- chronic Pa infection defined according to the Leeds criteria[17]
- pulmonary exacerbation needing IV AB treatment at time of new Pa isolate
- Pa isolation at time of CF diagnosis
- patient already on an antipseudomonal antibiotic
- interval between positive culture and start of treatment > 4 weeks.
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 |
|---|---|---|
| oral ciprofloxacin plus inhaled colistinAlso: Ciproxin ® - ciprofloxacin, Colistineb ®oral ciprofloxacin (30mg/kg/day divided in 2 doses) for 3 months (CC) plus inhaled colistimethate sodium(Colistineb® 2x2 mill U daily) | Drug | Ciproxin-inhaled Colistin |
| TOBIAlso: TOBI® - tobramycin inhalation solution (TIS)tobramycin inhalation solution (TOBI® 2x300 mg) for 28 days | Drug | Tobramycine for inhalation (TIS) |
Primary outcome
Pseudomonas aeruginosa eradication at the end of the treatment.
Time frame: end of study drug treatment ie 3 months for CC and at 1 months for TIS
sucessful eradication is defined as negative airway culture for P aeruginosa and end of study drug which is after 3 months for ciproxin-colistin (CC) and after 1 months for tobramycin for inhalation (TIS)
6 secondary outcomes
P aeruginosa eradication at 6 months after study entry
Time frame: 6 months
time to new Pa positive culture (= relapse)
Time frame: 1 year
change from baseline FEV1% pred, IgG z score, BMI z score was followed
Time frame: 1 year
Antibody titer for specific anti Pseudomonas antibodies
Time frame: 1 year
P aeruginosa infection status
Time frame: 1 year
P aeruginosa infection status
Time frame: 2 years
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 4 Aug 2011.
- Results publication: PubMed 19821321Langton Hewer SC, Smyth AR. Antibiotic strategies for eradicating Pseudomonas aeruginosa in people with cystic fibrosis. Cochrane Database Syst Rev. 2009 Oct 7;(4):CD004197. doi: 10.1002/14651858.CD004197.pub3.
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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.
Marijke J Proesmans, MD, PhD principal investigator
Dep pediatrics University Hospital Leuven Belgium
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 oral ciprofloxacin plus inhaled colistin and TOBI in people with Cystic Fibrosis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 5 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 4 Aug 2011. 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 Belgium. 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 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?
Pseudomonas aeruginosa eradication at the end of the treatment. (time frame: end of study drug treatment ie 3 months for CC and at 1 months for TIS). 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 NCT01400750, which also lists 1 linked publication.
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 4 Aug 2011.