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Comparison of 2 Treatment Regimens for Eradication of P Aeruginosa Infection in Children With Cystic Fibrosis (CCTOBI)

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
oral ciprofloxacin plus inhaled colistin
TOBI
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring cystic fibrosis- P aeruginosa- eradication-child

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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'.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Department of pediatrics, CF center Uuiversity Hospital Leuven

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ciproxin-inhaled Colistin

Tobramycine for inhalation (TIS)

Arm Description

oral ciprofloxacin (30mg/kg/day) plus inhaled colistimethate sodium (Colistineb® 2x2 mill U daily) for 3 months

tobramycin inhalation solution (TOBI® 2x300 mg) for 28 days

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

P aeruginosa eradication at 6 months after study entry
negative airway cultures for P aeruginosa up to 6 months after start of study drug
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)
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
Antibody titer for specific anti Pseudomonas antibodies
Pa antibodies (ELISA St Ag 1-17 )were measured at baseline and at 1 year follow-up
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)
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)

Full Information

First Posted
July 18, 2011
Last Updated
August 3, 2011
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT01400750
Brief Title
Comparison of 2 Treatment Regimens for Eradication of P Aeruginosa Infection in Children With Cystic Fibrosis
Acronym
CCTOBI
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
cystic fibrosis- P aeruginosa- eradication-child

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ciproxin-inhaled Colistin
Arm Type
Active Comparator
Arm Description
oral ciprofloxacin (30mg/kg/day) plus inhaled colistimethate sodium (Colistineb® 2x2 mill U daily) for 3 months
Arm Title
Tobramycine for inhalation (TIS)
Arm Type
Active Comparator
Arm Description
tobramycin inhalation solution (TOBI® 2x300 mg) for 28 days
Intervention Type
Drug
Intervention Name(s)
oral ciprofloxacin plus inhaled colistin
Other Intervention Name(s)
Ciproxin ® - ciprofloxacin, Colistineb ®
Intervention Description
oral ciprofloxacin (30mg/kg/day divided in 2 doses) for 3 months (CC) plus inhaled colistimethate sodium(Colistineb® 2x2 mill U daily)
Intervention Type
Drug
Intervention Name(s)
TOBI
Other Intervention Name(s)
TOBI® - tobramycin inhalation solution (TIS)
Intervention Description
tobramycin inhalation solution (TOBI® 2x300 mg) for 28 days
Primary Outcome Measure Information:
Title
Pseudomonas aeruginosa eradication at the end of the treatment.
Description
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)
Time Frame
end of study drug treatment ie 3 months for CC and at 1 months for TIS
Secondary Outcome Measure Information:
Title
P aeruginosa eradication at 6 months after study entry
Description
negative airway cultures for P aeruginosa up to 6 months after start of study drug
Time Frame
6 months
Title
time to new Pa positive culture (= relapse)
Description
Time to first new P aeruginosa positive airway culture (expressed in months starting from end of study drug)
Time Frame
1 year
Title
change from baseline FEV1% pred, IgG z score, BMI z score was followed
Description
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
Time Frame
1 year
Title
Antibody titer for specific anti Pseudomonas antibodies
Description
Pa antibodies (ELISA St Ag 1-17 )were measured at baseline and at 1 year follow-up
Time Frame
1 year
Title
P aeruginosa infection status
Description
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)
Time Frame
1 year
Title
P aeruginosa infection status
Description
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)
Time Frame
2 years

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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'. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marijke J Proesmans, MD, PhD
Organizational Affiliation
Dep pediatrics University Hospital Leuven Belgium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of pediatrics, CF center Uuiversity Hospital Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
19821321
Citation
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.
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Comparison of 2 Treatment Regimens for Eradication of P Aeruginosa Infection in Children With Cystic Fibrosis

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