Prospective Randomized Trial Comparing Oral Ciproxin Plus Inhaled Colistin With Tobramycin for Inhalation for Eradication of P Aeruginosa Infection in Children With Cystic Fibrosis. (CCTOBI)

NCT01400750 Phase 4 COMPLETED

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.

Details

Lead sponsor	Universitaire Ziekenhuizen KU Leuven
Phase	Phase 4
Status	COMPLETED
Enrolment	61
Start date	2001-08
Completion	2011-05

Conditions

• Cystic Fibrosis

Interventions

• oral ciprofloxacin plus inhaled colistin
• TOBI

Primary outcomes

• Pseudomonas aeruginosa eradication at the end of the treatment. — 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)

Countries

Belgium