Clinical Trial Results:
Pharmacokinetics of fosfomycin: a study in patients with prolonged treatment for urinary tract infection
Summary
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EudraCT number |
2018-000616-25 |
Trial protocol |
NL |
Global end of trial date |
01 Jan 2020
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Results information
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Results version number |
v1(current) |
This version publication date |
25 Dec 2021
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First version publication date |
25 Dec 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 |
T17-084
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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 |
Haga Teaching Hospital
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Sponsor organisation address |
Els Borst-Eijlersplein 245, The Hague, Netherlands,
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Public contact |
S.G. Kuiper, Haga Teaching Hospital, s.g.kuiper@lumc.nl
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Scientific contact |
S.G. Kuiper, Haga Teaching Hospital, s.g.kuiper@lumc.nl
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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 |
07 Feb 2020
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
01 Oct 2019
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Global end of trial reached? |
Yes
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Global end of trial date |
01 Jan 2020
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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 |
To evaluate the pharmacokinetics of fosfomycine in patients with prolonged fosfomycin therapy to treat urinary tract infection
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Protection of trial subjects |
none
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Apr 2018
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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 |
Netherlands: 12
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Worldwide total number of subjects |
12
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EEA total number of subjects |
12
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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) |
5
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From 65 to 84 years |
7
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85 years and over |
0
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Recruitment
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Recruitment details |
Recruitment was done from July 2019 till September 2019 in Haga Teaching Hospital, The Hague, The Netherlands | ||||||
Pre-assignment
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Screening details |
15 patients were screened and 12 were included in the trial. | ||||||
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 |
Not applicable
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Blinding used |
Not blinded | ||||||
Arms
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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 |
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Pharmaceutical forms |
Powder for oral solution in sachet
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Routes of administration |
Oral use
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Dosage and administration details |
3 gram once
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Investigational medicinal product name |
Fosfomycin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder for infusion
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Routes of administration |
Intravenous bolus use
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Dosage and administration details |
3 gram intravenous
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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 |
- |
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End point title |
Fosfomycin serum concentrations [1] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
-
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analysis is done. |
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Attachments |
Untitled (Filename: 20200120.IndividualPlotsLog.Model60.png) |
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No statistical analyses for this end point |
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End point title |
Pharmacokinetic parameters [2] | ||||||
End point description |
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End point type |
Primary
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End point timeframe |
-
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Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analysis is done. |
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Attachments |
Untitled (Filename: Figuur 2 2020-01-20- Predictions - VPC_Jasper.png) |
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No statistical analyses for this end point |
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End point title |
Urine fosfomycin concentration at day 1 [3] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
-
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Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analysis is done. |
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No statistical analyses for this end point |
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End point title |
Urine fosfomycine concentration at day 2 [4] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
-
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Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analysis is done. |
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No statistical analyses for this end point |
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End point title |
Urine fosfomycin concentration at day 3 [5] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
-
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Notes [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analysis is done. |
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
1 month
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||
Dictionary version |
24.1
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Reporting groups
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Reporting group title |
Fosfomycin
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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. | |||
None reported |