|- candidate number||1277|
|- NTR Number||NTR164|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||30-aug-2005|
|- Secondary IDs||N/A |
|- 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.|
|- ACRONYM||SPIN UTI study|
|- hypothesis||In MMC-children treated with CIC, the incidences of significant bacteriuria and pyelonephritic episodes are only slightly smaller in the group of subjects treated with LDCP compared to the group without LDCP.|
|- Healt Condition(s) or Problem(s) studied||Urinary tract infections, Meningomyelocele (MMC), Neuropathic bladder-sphincter dysfunction, Spina bifida|
|- 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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||21-feb-2005|
|- planned closingdate||1-mei-2008|
|- Target number of participants||170|
|- Interventions||The entire group with MMC and CIC is allocated randomly continuing LDCP or stopping LDCP.|
|- Primary outcome||1. Number of urinary tract infections;|
2. Number of pyelonephritic episodes.
|- Secondary outcome||Changes in antibiotic resistance patterns in the cultured uropathogens.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| P. Winkler-Seinstra|
|- CONTACT for SCIENTIFIC QUERIES||Dr. C.C.E. Jong-de Vos van Steenwijk, de|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU), Wilhelmina Children's Hospital (WKZ)|
(Source(s) of Monetary or Material Support)
|Wilhelmina Research Fund|
|- Brief summary||170 children with MMC and CIC will be randomised with informed consent in two groups: |
One with continuing LDCP and Second with LDCP stopped. Eligible subject will be recruited from the academic hositals in Utrecht and Nijmegen. Possibly also the academic hospitals in Leuven and Antwerp, Belgium will be involved. In all centers care and management of children with MMC know a long-standing team approach.
Recent ultrasound imaging of kidneys and bladder, as well as full urodynamic investigation results, will be available for each patient enrolled in the study and these baselines are repeated after the study. Over a period of 18 months a leucocyte esterase test (Combur 2) and a Uricult test (Uricult, Orion Diagnostica, Finland) are performed biweekly. Combined these tests have a high predictive value. All Uricult dipslides are sent to the laboratory of the treating hospital for incubation and, when positive, culturing to define the microorganism and its microbiologic properties.
Any occurence of fever is followed up and treated as a pyelonephritic episode.
After termination of the study a comparison of the incidences of significant bacteriuria and pyelonephritic episodes in the two groups is performed.
We expect that LDCP leads to a small decrease in the incidences of significant bacteriuria and pyelonephritic episodes, but induces UTI with more drug resistant microorganisms.
|- Main changes (audit trail)|
|- RECORD||23-aug-2005 - 27-feb-2007|