Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/09/2005
Date assigned
12/09/2005
Last edited
20/09/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr G.A. Tramper-Stranders

ORCID ID

Contact details

Wilhelmina Kinderziekenhuis
KH.01.419.0
Postbus 85090
Utrecht
3508 AB
Netherlands
+31 (0)30 2504000
g.tramper@umcutrecht.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR64

Study information

Scientific title

Acronym

POPeye-study

Study hypothesis

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

Ethics approval received from the local medical ethics committee

Study design

Multicentre, randomised, double blinded, placebo controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

01/07/2005

Overall trial end date

01/03/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Aged greater than 18 years
2. P. aeruginosa in cultures after 2003
3. Participating in another trial

Recruitment start date

01/07/2005

Recruitment end date

01/03/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

Wilhelmina Kinderziekenhuis
Utrecht
3508 AB
Netherlands

Sponsor information

Organisation

University Medical Center Utrecht (UMCU) (The Netherlands)

Sponsor details

Heidelberglaan 100
Utrecht
3584 CX
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.umcutrecht.nl/zorg/

Funders

Funder type

Research organisation

Funder name

Added 12/09/2008:

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Initial funding was from the investigator for one year (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Dutch Cystic Fibrosis Foundation (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20729233

Publication citations

  1. Results

    Tramper-Stranders GA, Wolfs TF, van Haren Noman S, van Aalderen WM, Nagelkerke AF, Nuijsink M, Kimpen JL, van der Ent CK, Controlled trial of cycled antibiotic prophylaxis to prevent initial Pseudomonas aeruginosa infection in children with cystic fibrosis., Thorax, 2010, 65, 10, 915-920, doi: 10.1136/thx.2009.126128.

Additional files

Editorial Notes