|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
Netherlands Trial Register |
|
Last refreshed on:
|
28 April 2013 |
|
Main ID: |
NTR164 |
|
Date of registration:
|
30/08/2005 |
|
Primary sponsor: |
|
|
Public title:
|
Low dose chemoprofylaxis (LDCP) and reduction of pyelonephritic episodes and significant bacteriuria in children with meningomyelocele and clean intermittent catherisation (CIC).
|
|
Scientific title:
|
LDCP and reduction of pyelonephritic episodes and significant bacteriuria in children with meningomyelocele and CIC. - SPIN UTI study |
|
Date of first enrolment:
|
21/2/2005 |
|
Target sample size:
|
170 |
|
Recruitment status: |
recruiting |
|
URL:
|
http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=164 |
|
Study type:
|
intervention |
|
Study design:
|
Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: -
|
|
|
Countries of recruitment
|
|
The Netherlands
| | | | | | | |
|
Contacts
|
|
Name:
|
C.C.E.
Jong-de Vos van Steenwijk, de |
|
Address:
|
University Medical Center Utrecht (UMCU),
Wilhelmina Children's Hospital,
Department of Pediatrics,
KE04.133.1,
P.O. Box 85090
3508 AB
Utrecht
The Netherlands |
|
Telephone:
|
+31 (0)30 2504001 |
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
P.
Winkler-Seinstra |
|
Address:
|
University Medical Center Utrecht (UMCU),
Wilhelmina Children's Hospital,
Department of Pediatrics,
KE04.133.1,
P.O. Box 85090
3508 AB
Utrecht
The Netherlands |
|
Telephone:
|
+31 (0)30 2504001 |
|
Email:
|
p.winkler@umcutrecht.nl |
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: 1. Neuropathic bladder-sphincter dysfunction;
2. CIC and use of LDCP for at least 6 months;
3. Good possibillities for communication;
4. Written informed consent.
Exclusion criteria:
1. Urinary tract infection (UTI) or
- pyelonephritis at inclusion;
2. Fever e.c.i.;
3. Other neurologic diseases;
4. Other diseases like IDDM that can cause UTI.
Age minimum:
Age maximum:
Gender:
|
|
Health Condition(s) or Problem(s) studied
|
Urinary tract infections, Meningomyelocele (MMC), Neuropathic bladder-sphincter dysfunction, Spina bifida
|
|
Intervention(s)
|
|
The entire group with MMC and CIC is allocated randomly continuing LDCP or stopping LDCP.
|
|
Primary Outcome(s)
|
1. Number of urinary tract infections;
2. Number of pyelonephritic episodes.
|
|
Secondary Outcome(s)
|
|
Changes in antibiotic resistance patterns in the cultured uropathogens.
|
|
Secondary ID(s)
|
|
ISRCTN56278131
|
|
N/A
|
|
Source(s) of Monetary Support
|
|
Wilhelmina Research Fund
|
|