Clinical Trial Results:
Pharmacokinetics of ciprofloxacine in pediatric patients, a pilot study – SAFE PEDRUG
Summary
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EudraCT number |
2014-004638-24 |
Trial protocol |
BE |
Global end of trial date |
17 Mar 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
03 Apr 2022
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First version publication date |
03 Apr 2022
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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 |
SafePed01
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02598362 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Ghent University Hospital
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Sponsor organisation address |
C. Heymanslaan 10, 9000, Belgium, Ghent
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Public contact |
HIRUZ CTU, Ghent University Hospital, +32 93320500, hiruz.ctu@uzgent.be
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Scientific contact |
HIRUZ CTU, Ghent University Hospital, +32 93320500, hiruz.ctu@uzgent.be
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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 |
06 Sep 2018
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
17 Mar 2017
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Global end of trial reached? |
Yes
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Global end of trial date |
17 Mar 2017
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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 |
Investigating the feasibility of a study method for pharmacokinetics (with emphasis on renal clearance) of ciprofloxacin in children.
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Protection of trial subjects |
Ethics review and approval, informed consent, supportive care and routine monitoring.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
28 May 2015
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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 |
Belgium: 23
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Worldwide total number of subjects |
23
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EEA total number of subjects |
23
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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) |
3
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Children (2-11 years) |
10
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Adolescents (12-17 years) |
10
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
23 patients were included starting from 28-May-2015. End of trial notification was dated 17-Mar-2018 (last patient last visit) and submitted to EC and CA on 28/08/2018. | |||||||||
Pre-assignment
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Screening details |
fUTI group (UZ Brussels): patients aged 3 months-17years with rectal temperature of 38.5°C and significant leucocyturia or a positive urine nitrite test in a sterile urine sample and confirmed by culture. Profylaxis group (UZ Ghent): patients until age of 17years who use cipro for preventing urinary tract infectons. | |||||||||
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 |
Non-randomised - controlled
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Blinding used |
Not blinded | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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fUTI arm (IV arm) | |||||||||
Arm description |
UZ Brussels patients aged 3 months-17years with rectal temperature of 38.5°C and significant leucocyturia or a positive urine nitrite test in a sterile urine sample and confirmed by culture. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Ciprofloxacin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
15mg/kg twice daily
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Arm title
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Profylaxis arm (oral arm) | |||||||||
Arm description |
UZ Ghent patients until age of 17years who use cipro for preventing urinary tract infectons. Oral administration | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Ciprofloxacin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for oral suspension
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Routes of administration |
Oral use
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Dosage and administration details |
Normal dose (usual 10mg/kg daily)
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Baseline characteristics reporting groups
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Reporting group title |
fUTI arm (IV arm)
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Reporting group description |
UZ Brussels patients aged 3 months-17years with rectal temperature of 38.5°C and significant leucocyturia or a positive urine nitrite test in a sterile urine sample and confirmed by culture. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Profylaxis arm (oral arm)
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Reporting group description |
UZ Ghent patients until age of 17years who use cipro for preventing urinary tract infectons. Oral administration | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
fUTI arm (IV arm)
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Reporting group description |
UZ Brussels patients aged 3 months-17years with rectal temperature of 38.5°C and significant leucocyturia or a positive urine nitrite test in a sterile urine sample and confirmed by culture. | ||
Reporting group title |
Profylaxis arm (oral arm)
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Reporting group description |
UZ Ghent patients until age of 17years who use cipro for preventing urinary tract infectons. Oral administration | ||
Subject analysis set title |
End group
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Group created as data are analysed as a one armed trial.
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End point title |
ciprofloxacin clearance [1] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
From start until end of study
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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: See article |
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No statistical analyses for this end point |
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End point title |
Volume of distribution | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
From start until end of study
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No statistical analyses for this end point |
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End point title |
Bioavailibility | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
From start until end study
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No statistical analyses for this end point |
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End point title |
absorption | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
From start until end study
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
Adverse events will be reported between the first dose administration of trial medication and the last trial related activity
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Assessment type |
Non-systematic | |||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||
Dictionary version |
21.1
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Reporting groups
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Reporting group title |
fUTI arm (IV arm)
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Reporting group description |
UZ Brussels patients aged 3 months-17years with rectal temperature of 38.5°C and significant leucocyturia or a positive urine nitrite test in a sterile urine sample and confirmed by culture. | |||||||||||||||
Reporting group title |
Profylaxis arm (oral arm)
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Reporting group description |
UZ Ghent patients until age of 17years who use cipro for preventing urinary tract infectons. Oral administration | |||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||
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Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No adverse events have been collected |
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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 | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/29987142 |