Respiratory infections with Pseudomonas aeruginosa in children with Cystic Fibrosis; early surveillance and prevention

ISRCTN	ISRCTN11604593
DOI	https://doi.org/10.1186/ISRCTN11604593
Protocol serial number	NTR64
Sponsor	University Medical Center Utrecht (UMCU) (The Netherlands)
Funders	Added 12/09/2008:, Initial funding was from the investigator for one year (Netherlands), Dutch Cystic Fibrosis Foundation (Netherlands)

Submission date: 12/09/2005
Registration date: 12/09/2005
Last edited: 20/09/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr G.A. Tramper-Stranders
Scientific

Wilhelmina Kinderziekenhuis
KH.01.419.0
Postbus 85090
Utrecht
3508 AB
Netherlands

Phone	+31 (0)30 2504000
Email	g.tramper@umcutrecht.nl

Study information

Primary study design	Interventional
Study design	Multicentre, randomised, double blinded, placebo controlled, parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	POPeye-study
Study objectives	Our hypothesis is that the initial infection with P. aeruginosa occurs at earlier age than previously reported and that prophylactic treatment of P. aeruginosa-negative CF-patients will either prevent or delay the first acquisition of P.aeruginosa or eradicate the organism before the onset of persistent colonization and accompanying pulmonary inflammatory response. Please note that as of 12/09/2008, the sources of funding field was updated. The anticipated end date of this trial was also updated. The previous anticipated end date was 01/11/2008.
Ethics approval(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	Pulmonary P. aeruginosa infection, cystic fibrosis
Intervention	Ciprofloxacin 10 mg/kg orally (po) or matching placebo twice daily (bid) and colistin 1 MIU inhalation or matching placebo bid. Three-monthly courses of three weeks, total study duration 3 years.
Intervention type	Other
Primary outcome measure(s)	Early P. aeruginosa colonisation as confirmed by: 1. Persistence of P. aeruginosa in sputum or oropharygeal swab culture in two consecutive samples, taken greater than 3 days apart 2. P. aeruginosa in one oropharyngeal swab or sputum culture with pulmonary exacerbation
Key secondary outcome measure(s)	Microbiological: 1. Age at first positive culture 2. Time to P. aeruginosa colonisation 3. Respiratory pathogens in culture 4. Resistance pattern of respiratory pathogens Serological: 5. Seroconversion for anti-pseudomonal antibodies Clinical: 6. Adverse events 7. Clinical parameters (lung function, body weight and chest radiograph scores, inflammation parameters) 8. Number of pulmonal exacerbations 9. Antimicrobial agent use
Completion date	01/03/2009

Eligibility

Participant type(s)	Patient
Age group	Child
Upper age limit	18 Years
Sex	All
Target sample size at registration	100
Key inclusion criteria	1. CF diagnosis as confirmed by sweat chloride test and/or genotyping 2. Aged less than 18 years old 3. No evidence of P. aeruginosa in cultures taken in period 2004 - 2005 4. Antibody titer less than 1:1250 for three antigens of P. aeruginosa 5. No regular treatment against P. aeruginosa 6. Informed consent
Key exclusion criteria	1. Aged greater than 18 years 2. P. aeruginosa in cultures after 2003 3. Participating in another trial
Date of first enrolment	01/07/2005
Date of final enrolment	01/03/2009

Locations

Countries of recruitment

Netherlands

Study participating centre

Wilhelmina Kinderziekenhuis

Utrecht
3508 AB
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2010		Yes	No