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

This study has been completed.
Sponsor:
Information provided by:
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01400750
First received: July 18, 2011
Last updated: August 3, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Cystic Fibrosis
 Drug: oral ciprofloxacin plus inhaled colistin
Drug: TOBI
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    negative airway cultures for P aeruginosa up to 6 months after start of study drug

  • time to new Pa positive culture (= relapse) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Pa antibodies (ELISA St Ag 1-17 )were measured at baseline and at 1 year follow-up

  • P aeruginosa infection status [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]

    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)



Enrollment: 61
Study Start Date: August 2001
Study Completion Date: May 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ciproxin-inhaled Colistin
oral ciprofloxacin (30mg/kg/day) plus inhaled colistimethate sodium (Colistineb® 2x2 mill U daily) for 3 months
 Drug: oral ciprofloxacin plus inhaled colistin
oral ciprofloxacin (30mg/kg/day divided in 2 doses) for 3 months (CC) plus inhaled colistimethate sodium(Colistineb® 2x2 mill U daily)
Other Names:
  • Ciproxin ® - ciprofloxacin
  • Colistineb ®
Active Comparator: Tobramycine for inhalation (TIS)
tobramycin inhalation solution (TOBI® 2x300 mg) for 28 days
 Drug: TOBI
tobramycin inhalation solution (TOBI® 2x300 mg) for 28 days
Other Name: TOBI® - tobramycin inhalation solution (TIS)

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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01400750

Locations
Belgium
Department of pediatrics, CF center Uuiversity Hospital Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Marijke J Proesmans, MD, PhD Dep pediatrics University Hospital Leuven Belgium
  More Information

Publications:

Responsible Party: Prof M Proesmans, University Hospital Leuven, dep of pediatrics
ClinicalTrials.gov Identifier: NCT01400750     History of Changes
Other Study ID Numbers: MP1
Study First Received: July 18, 2011
Last Updated: August 3, 2011
Health Authority: Belgium: Ethics Committee

Keywords provided by Universitaire Ziekenhuizen Leuven:
cystic fibrosis- P aeruginosa- eradication-child

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Tobramycin
 Colistin
Ciprofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013