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Completed

NCT Number: NCT01862822

Position of Children During Urine Collection: Evaluation Study

Urinary tract infection (UTI) is a frequently suspected cause of fever in young children, justifying urine cultures. Sampling procedures are decisive for the reliability of UTI diagnosis. Even though official guidelines recommend clean catch method, catheterization or suprapubic aspiration, urine bag collection remains widely used. In our experience, the rate of contaminated bag-obtained cultures reaches 30.2 %. In a recent study, the investigators have noticed that the rate of contaminated urine cultures was lower when children were kept in an upright position at the time of urine collection. The upright position could explain this decrease, perineum being less in contact with urine. These results are borderline significant, the investigators would like to confirm them with a specific study.

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Key information

Conditions

Urinary Infection Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

2 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital, Limoges

Limoges, 87 042, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children aged 2 - 36 months
  • Non-toilet-trained children
  • Indication to bag urine collection with the following criteria :
  • fever ≥ 38.5 °C
  • unexplained fever
  • and at least 1 of the following criteria for girls and uncircumcised boys, at least 2 criteria for circumcised boys :
  • age ≤ 12 months
  • fever ≥ 48 hours
  • poorly tolerated fever (chills ± cyanosis ± pronounced weakness…)
  • preceding episode of tract urine infection

Exclusion criteria

  • Parents opposed to the participation of their children in the study
  • Diarrhea
  • Current antibiotic treatment or during the 8 preceding days of the urine collection
  • Genitals / perineal anomaly

Treatment and study plan

upright position

Other

Other names: the impact of an upright position on the number of contaminated urine cultures during urine bag collection

Primary outcomes

  1. Proportion of polybacterial urine analysis in each group

    Time frame: 1 hour

Secondary outcomes

  1. The failure rate in upright position in private practice

    Time frame: 1 hour.

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Acronym: PUCES

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
May 27, 2013
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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