Clinical Trial Results:
ABSORB 2:An exploratie study determining the oral antibiotic drug absorption in patients with short bowel syndrome.
Summary
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EudraCT number |
2019-002587-28 |
Trial protocol |
NL |
Global end of trial date |
07 Jan 2022
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Results information
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Results version number |
v1(current) |
This version publication date |
24 Aug 2023
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First version publication date |
24 Aug 2023
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Other versions |
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Summary report(s) |
Article |
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 |
2019-5165
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
Nederlands Trial Register: NL7796 | ||
Sponsors
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Sponsor organisation name |
Radboud university medical center
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Sponsor organisation address |
Geert grooteplein zuid 10, Nijmegen, Netherlands, 6500HB
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Public contact |
Michelle Gompelman, Radboudumc, 31 243093767, Michelle.Gompelman@radboudumc.nl
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Scientific contact |
Michelle Gompelman, Radboudumc, 31 243093767, Michelle.Gompelman@radboudumc.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 |
01 Nov 2022
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
07 Jan 2022
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Global end of trial reached? |
Yes
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Global end of trial date |
07 Jan 2022
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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 |
The primary objective is to determine the absorption of orally administered antibiotics in patients with SBS, to guide in clinical decision making when faced with catheter related infections.
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Protection of trial subjects |
In general, this study aims to restrict the physical and mental burdens for the subject as much as possible. The physical risks that are introduced by this study to the participants are believed to be minimal. The risk derives from collecting the blood are negligible if performed by well-trained physicians and/or nurses.
Next to this, the antimicrobial agents as prescribed as a single dose, have the potential risk of developing side effects, certain toxicities and allergies or intolerance. These potential risks however, are low since only a single dosage is given and are mostly wellknown because the antibiotics are prescribed frequently.
During the study, there will be sufficient medical health assistance (nurse practitioners, attending physician or principle investigator) present at all times in the hospital and reachable by phone to cope with unexpected events.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
23 Jul 2020
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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: 18
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Worldwide total number of subjects |
18
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EEA total number of subjects |
18
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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) |
9
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From 65 to 84 years |
9
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85 years and over |
0
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Recruitment
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Recruitment details |
Participants will be included at the outpatient clinic of the Radboudumc Gastroenterology and Hepatology department. Patients with an indication for HPN training or other intervention that requires elective admission without presence of exclusion criteria for the study will be asked by their treating physician to participate in the study. | ||||||
Pre-assignment
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Screening details |
Due to the explorative nature of the study, no blinding will be performed. After checking the inclusion- and exclusion criteria by the physician/principal investigator and informed consent is given, 8 patients are assigned to the CC-group and the other 8 patients to the FF-group. | ||||||
Period 1
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Period 1 title |
Full study (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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Everyone | ||||||
Arm description |
- | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
fluconazole
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for oral suspension, Capsule
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Routes of administration |
Enteral use , Infusion
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Dosage and administration details |
Flucanozole 400mg IV and oral dose (suspension) is an antifungal agent belonging to the triazole class.
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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 |
Capsule, Suspension for oral suspension
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Routes of administration |
Enteral use , Infusion
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Dosage and administration details |
Ciprofloxacin 750mg oral dose (suspension) and 400mg IV dose, is a fluoroquinolone
antibiotic.
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Investigational medicinal product name |
Clindamycin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule, Suspension for oral suspension
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Routes of administration |
Enteral use , Infusion
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Dosage and administration details |
Clindamycin 600mg IV and oral dose (suspension) belongs to the lincosamide class
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Investigational medicinal product name |
Flucloxacillin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule, Suspension for oral suspension
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Routes of administration |
Enteral use , Infusion
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Dosage and administration details |
Flucloxacillin 1000mg IV and oral dose (tablet/suspension) is a beta-lactam antibiotic.
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Baseline characteristics reporting groups
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Reporting group title |
Full study
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Full analysis
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Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
full analysis
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End points reporting groups
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Reporting group title |
Everyone
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Reporting group description |
- | ||
Subject analysis set title |
Full analysis
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
full analysis
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End point title |
Oral bioavailability [1] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Oral bioavailability of ciprofloxacin, clindamycin, flucloxacillin and fluconazole in patients with SBS.
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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: Please see article voor statistical analysis |
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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 |
We reported the adverse events after adverse event on toetsing online.
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Assessment type |
Systematic | ||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||
Dictionary version |
1
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Reporting groups
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Reporting group title |
Everyone
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Reporting group description |
- | ||||||||||||||||||||||
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 non-serious adverse events |
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Notes [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: This is correct |
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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 |