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

Cystic Fibrosis Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01400750
• Other study ID #: MP1
• Status: Completed
• Phase: Phase 4
• First received: July 18, 2011
• Last updated: August 3, 2011
• Start date: August 2001
• Est. completion date: May 2011

Study information

• Verified date: July 2011
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: May 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

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

Locations

Country	Name	City	State
Belgium	Department of pediatrics, CF center Uuiversity Hospital Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

References & 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. Review. Update in: Cochrane Database Syst Re — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	P aeruginosa eradication at 6 months after study entry	negative airway cultures for P aeruginosa up to 6 months after start of study drug	6 months	No
Secondary	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)	1 year	No
Secondary	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	1 year	No
Secondary	Antibody titer for specific anti Pseudomonas antibodies	Pa antibodies (ELISA St Ag 1-17 )were measured at baseline and at 1 year follow-up	1 year	No
Secondary	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)	1 year	No
Secondary	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)	2 years	No