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Low dose chemoprofylaxis (LDCP) and reduction of pyelonephritic episodes and significant bacteriuria in children with meningomyelocele and clean intermittent catherisation (CIC).


- candidate number1277
- NTR NumberNTR164
- ISRCTNISRCTN56278131
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR30-aug-2005
- Secondary IDsN/A 
- Public TitleLow dose chemoprofylaxis (LDCP) and reduction of pyelonephritic episodes and significant bacteriuria in children with meningomyelocele and clean intermittent catherisation (CIC).
- Scientific TitleLDCP and reduction of pyelonephritic episodes and significant bacteriuria in children with meningomyelocele and CIC.
- ACRONYMSPIN UTI study
- hypothesisIn 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) studiedUrinary tract infections, Meningomyelocele (MMC), Neuropathic bladder-sphincter dysfunction, Spina bifida
- Inclusion criteria1. 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 receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 21-feb-2005
- planned closingdate1-mei-2008
- Target number of participants170
- InterventionsThe entire group with MMC and CIC is allocated randomly continuing LDCP or stopping LDCP.
- Primary outcome1. Number of urinary tract infections;
2. Number of pyelonephritic episodes.
- Secondary outcomeChanges in antibiotic resistance patterns in the cultured uropathogens.
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES P. Winkler-Seinstra
- CONTACT for SCIENTIFIC QUERIESDr. C.C.E. Jong-de Vos van Steenwijk, de
- Sponsor/Initiator University Medical Center Utrecht (UMCU), Wilhelmina Children's Hospital (WKZ)
- Funding
(Source(s) of Monetary or Material Support)
Wilhelmina Research Fund
- PublicationsN/A
- Brief summary170 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)
- RECORD23-aug-2005 - 27-feb-2007


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