Respiratory infections with Pseudomonas aeruginosa in children with Cystic Fibrosis; early surveillance and prevention
| ISRCTN | ISRCTN11604593 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11604593 |
| Secondary identifying numbers | NTR64 |
- 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
Scientific
Wilhelmina Kinderziekenhuis
KH.01.419.0
Postbus 85090
Utrecht
3508 AB
Netherlands
| Phone | +31 (0)30 2504000 |
|---|---|
| g.tramper@umcutrecht.nl |
Study information
| Study design | Multicentre, randomised, double blinded, placebo controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| 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 | 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 study start date | 01/07/2005 |
| Completion date | 01/03/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
3508 AB
Netherlands
Sponsor information
University Medical Center Utrecht (UMCU) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Heidelberglaan 100
Utrecht
3584 CX
Netherlands
| Website | http://www.umcutrecht.nl/zorg/ |
|---|---|
"ROR" |
https://ror.org/0575yy874 |
Funders
Funder type
Research organisation
Added 12/09/2008:
No information available
Initial funding was from the investigator for one year (Netherlands)
No information available
Dutch Cystic Fibrosis Foundation (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
