NCT01400750

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2001

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 22, 2011

Completed
Last Updated

August 4, 2011

Status Verified

July 1, 2011

Enrollment Period

9 years

First QC Date

July 18, 2011

Last Update Submit

August 3, 2011

Conditions

Cystic Fibrosis

Keywords

cystic fibrosis- P aeruginosa- eradication-child

Outcome Measures

Primary Outcomes (1)

  • 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)

    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

    6 months

  • time to new Pa positive culture (= relapse)

    1 year

  • change from baseline FEV1% pred, IgG z score, BMI z score was followed

    1 year

  • Antibody titer for specific anti Pseudomonas antibodies

    1 year

  • P aeruginosa infection status

    1 year

  • +1 more secondary outcomes

Study Arms (2)

Ciproxin-inhaled Colistin

ACTIVE COMPARATOR

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

Drug: oral ciprofloxacin plus inhaled colistin

Tobramycine for inhalation (TIS)

ACTIVE COMPARATOR

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

Drug: TOBI

Interventions

oral ciprofloxacin plus inhaled colistinDRUG

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

Also known as: Ciproxin ® - ciprofloxacin, Colistineb ®
Ciproxin-inhaled Colistin
TOBIDRUG

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

Also known as: TOBI® - tobramycin inhalation solution (TIS)
Tobramycine for inhalation (TIS)

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)
  • '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'.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of pediatrics, CF center Uuiversity Hospital Leuven

Leuven, 3000, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 19821321RESULT

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Ciprofloxacin

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Marijke J Proesmans, MD, PhD

    Dep pediatrics University Hospital Leuven Belgium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 18, 2011

First Posted

July 22, 2011

Study Start

August 1, 2001

Primary Completion

August 1, 2010

Study Completion

May 1, 2011

Last Updated

August 4, 2011

Record last verified: 2011-07

Locations

BE(1)