Clinical Trial Results:
Impact of eradication of asymptomatic bacteriuria on reducing the incidence of early infection in patients with periprosthetic femoral fractures requiring hip hemiarthroplasty
Summary
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EudraCT number |
2016-001108-47 |
Trial protocol |
ES |
Global end of trial date |
01 Jan 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
21 Oct 2021
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First version publication date |
21 Oct 2021
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
BARIFER
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
VHIR
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Sponsor organisation address |
Passeig Vall Hebron 119-129, Barcelona, Spain, 08035
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Public contact |
Joaquin Lopez-Soriano, VHIR, joaquin.lopez.soriano@vhir.org
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Scientific contact |
Inmaculada Fuentes, VHIR - Unitat de Suport a la Investigació Clinica (USIC), usic@vhir.org
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
30 Nov 2018
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
30 Nov 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
01 Jan 2019
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Evaluate the clinical impact of eradication of asymptomatic bacteriuria on reducing the incidence of early periprosthetic infection in patients with femur fracture requiring hip hemiarthroplasty.
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Protection of trial subjects |
Urine analysis was performed before HHA surgery. Preoperative antibiotic prophylaxis was decided according to each center protocol. All patients were followed for three months after HHA or until early-PJIs or death was diagnosed, whichever occurred first.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
02 May 2016
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Spain: 594
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Worldwide total number of subjects |
594
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EEA total number of subjects |
594
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
94
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From 65 to 84 years |
450
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85 years and over |
50
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Recruitment
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Recruitment details |
- | ||||||||||||
Pre-assignment
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Screening details |
- | ||||||||||||
Pre-assignment period milestones
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Number of subjects started |
594 | ||||||||||||
Number of subjects completed |
594 | ||||||||||||
Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||
Roles blinded |
Subject, Investigator | ||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Fosfomycin | ||||||||||||
Arm description |
- | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
Fosfomycin
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Investigational medicinal product code |
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Other name |
Monuril, Monurol, Monural
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Pharmaceutical forms |
Oral powder in single-dose container
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Routes of administration |
Oral use
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Dosage and administration details |
3 g of fosfomycin-trometamol (oral route) vs. no treatment, between 24 and 6h before surgery.
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Arm title
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No treatment | ||||||||||||
Arm description |
- | ||||||||||||
Arm type |
No intervention | ||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Arm title
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Non ASB | ||||||||||||
Arm description |
- | ||||||||||||
Arm type |
No intervention | ||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Fosfomycin
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Reporting group description |
- | ||
Reporting group title |
No treatment
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Reporting group description |
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Reporting group title |
Non ASB
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Reporting group description |
- |
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End point title |
Cumulative incidence PJI | ||||||||||||||||
End point description |
Cumulative incidence of early PJI (periprosthetic joint infection ) after preoperative ASB (asymptomatic bacteriuria) treatment in patients with hip hemiarthroplasty (HHA) for fracture.
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End point type |
Primary
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End point timeframe |
12 weeks
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Statistical analysis title |
Early PJI | ||||||||||||||||
Comparison groups |
No treatment v Fosfomycin
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Number of subjects included in analysis |
152
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
> 0.5 | ||||||||||||||||
Method |
t-test, 2-sided | ||||||||||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
12 weeks
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
14.1
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Reporting groups
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Reporting group title |
Total cohort
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
The main limitation was the small sample size. The difficulty of obtaining the informed consent signed and all study requirements at least 6h before surgery made our inclusion rate slow | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/33864153 |