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CIRCumcision and Urinary Tract Infections in Boys With Posterior Urethral Valves (CIRCUP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Centre Hospitalier Universitaire de la Réunion
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de la Réunion
ClinicalTrials.gov Identifier:
NCT01537601
First received: February 17, 2012
Last updated: July 24, 2014
Last verified: July 2014

February 17, 2012
July 24, 2014
August 2012
August 2018   (final data collection date for primary outcome measure)
Relative risk of presenting a febrile UTI [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01537601 on ClinicalTrials.gov Archive Site
  • Number of children with febrile UTIs in each group at two years [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Evolution of compliance to antibioprophylaxis. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Evolution of the grade of reflux [ Time Frame: At diagnosis and at 3 months ] [ Designated as safety issue: No ]
  • Comparison of the number of children who will show deterioration of their DMSA scan between children who have had UTIs and those who have not. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • number and type of adverse effects related to circumcision and antibiotic prophylaxis [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Identification of the responsible bacteria [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
CIRCumcision and Urinary Tract Infections in Boys With Posterior Urethral Valves
Effect of Circumcision on the Risk of Febrile Urinary Tract Infections in Children With Posterior Urethral Valves.

Children with posterior urethral valves (PUV) are at risk of presenting febrile urinary tract infections (UTI). Circumcision has been shown to decrease the number of febrile UTIs in healthy children. The effect of circumcision on the number of UTIs in boys with PUV has not yet been studied. Through a prospective randomised trial of children with posterior urethral valves the investigators wish to determine the effect of circumcision on the risk of presenting febrile UTIs. One group will be on antibiotic prophylaxis alone and the other will be on antibiotic prophylaxis plus circumcision performed at the time of valve resection. Both groups will be followed for two years, with clinical examination at 1, 3, 6, 12, 18 and 24 months. A DMSA scan will be performed at 1-2 and 24 months and biological renal function will also be monitored. The relative risk of presenting a febrile UTI in each group will be determined. Clinical, radiological and antenatal data concerning each child will be analysed.

After diagnosis of posterior urethral valves, children will be randomised either to antibioprophylaxis alone or antibioprophylaxis plus circumcision. Circumcision will be performed at the time of valve resection. Children will undergo a cystogram between 1 and 4 months to control valve resection. They will be followed for two years and the number of febrile UTIs in each group will be compared. The diagnosis of febrile UTI will be confirmed by urethral catheterisation or suprapubic aspiration. A DMSA scan will be performed at the beginning and end of the study to determine whether children who have presented febrile UTIs show deterioration of their DMSA as compared to those who did not present febrile UTIs.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Posterior Urethral Valves
  • Procedure: Circumcision
    Circumcision
  • Other: Antibiotic prophylaxis alone
    Antibiotic prophylaxis alone
  • Antibiotic prophylaxis alone
    Children will be on antibioprophylaxis and will not have a circumcision.
    Intervention: Other: Antibiotic prophylaxis alone
  • Experimental: Circumcision and antibiotic prophylaxis
    Children will have a circumcision at the time of valve resection and will be on antibioprophylaxis
    Intervention: Procedure: Circumcision

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
August 2018
August 2018   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • male
  • aged 0 to 28 days
  • diagnosed with posterior urethral valves within the 28 first day of life
  • holders of parental authority affiliated to French national health insurance
  • informed consent signed by holders of parental authority

Exclusion Criteria:

  • boys with hypospadias or epispadias or any other anomaly rendering circumcision impossible
  • concomitant participation to another clinical trial
Male
up to 28 Days
No
Contact: Luke harper, MD +262 (0) 262 90 64 94 luke.harper@chu-reunion.fr
Contact: Vanessa Basque +262 (0) 262 35 95 25 vanessa.basque@chu-reunion.fr
France
 
NCT01537601
2012/CHR/01
No
Centre Hospitalier Universitaire de la Réunion
Centre Hospitalier Universitaire de la Réunion
Not Provided
Principal Investigator: Luke Harper, MD Regional Hospital Reunion Island - Felix Guyon Site
Principal Investigator: Eric Dobremez, MD CHU Bordeaux, Hôpital Pellegrin Enfants
Principal Investigator: Laurent Fourcade, MD CHU Limoges - Hôpital de la mère et de l'enfant
Principal Investigator: Nicolas Kalfa, MD CHU Montpellier - Hôpital Lapeyronie
Principal Investigator: Frédéric Auber, MD CHU St Jacques - Besançon
Principal Investigator: Benjamin Frémond CHU Rennes
Principal Investigator: Al El Ghoneimi, MD CHU Robert Debré
Principal Investigator: Thomas Blanc, MD CHU de Necker Enfants Malades
Principal Investigator: Jean Michel Guys, MD Hôpital d'enfants de la Timone, Marseille
Principal Investigator: Thierry Merrot, MD CHU Nord, Marseille
Principal Investigator: Marc David Leclair, MD CHU Nantes
Principal Investigator: Georges Audry, MD CHU Armand Trousseau, Paris
Centre Hospitalier Universitaire de la Réunion
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP