In this study we want to assess the hepatic cyst penetration capacity of intravenously administered antibiotics (ciprofloxacin, co-trimoxazole, doxycycline and piperacillin/tazobactam) by comparing blood and cyst fluid concentrations in patients…
ID
Source
Brief title
Condition
- Hepatic and hepatobiliary disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of the study is the hepatic cyst penetration of
ciprofloxacin, co-trimoxazole, doxycycline and piperacillin/tazobactam, defined
as the ratio (%) of cyst aspirate concentration (mg/ml) to blood plasma
concentration (mg/ml).
Secondary outcome
• Plasma concentration curve, consisting of 6 measurements (every 1.5 hours) in
blood plasma.
• Cyst parameters.
• Cyst fluid biochemical analysis (protein, albumin, haemocytometrics,
bilirubin, pH)
• Blood biochemical analysis (protein, albumin, haemocytometrics, bilirubin,
creatinine)
• Demographic information, medical history, concomitant medication
• Complications or adverse events
Background summary
Hepatic cysts are fluid-filled cavities located in the liver parenchyma.
Spontaneous cyst infection presents a severe complication of hepatic cystic
disease requiring frequent hospitalization, long-term antibiotic treatment, and
in some patients, invasive therapies. It is most commonly caused by Escherichia
coli strains and first-line treatment is ciprofloxacin. However, 10-47% of
Escherichia coli strains in Europe are resistant to fluoroquinolones (e.g.
ciprofloxacin) and fluoroquinolones fail in 50% of cyst infections. Even after
successful treatment, recurrence is as high as 20%. Highlighting the need for
novel (evidence-based) antimicrobial regimens. In addition, evidence that the
used antibiotics are able to reach adequate intracystic concentrations is
scarce.
Study objective
In this study we want to assess the hepatic cyst penetration capacity of
intravenously administered antibiotics (ciprofloxacin, co-trimoxazole,
doxycycline and piperacillin/tazobactam) by comparing blood and cyst fluid
concentrations in patients undergoing aspiration sclerotherapy for
non-infected, large, symptomatic, hepatic cysts.
Study design
Explorative single-centre study, in which patients will be placed in two
groups: single dose intravenous piperacillin/tazobactam in combination with
ciprofloxacin, or intravenous co-trimoxazole in combination with doxycycline.
Within these groups patients will be randomized in two time-groups: antibiotics
2 to 3 hours before aspiration, or 5-6 hours before aspiration to ensure a
time-range of measurements.
Intervention
Group 1: intravenous piperacillin/tazobactam (4000/500 mg) in combination with
ciprofloxacin (400 mg) .
Group 2: intravenous co-trimoxazole (960 mg) in combination with doxycycline
(200 mg).
Study burden and risks
We deem this to be a low-risk study. Patient will receive a single dosage of
one or two registered products that have been used extensively in a clinical
setting for infections and possible adverse events are widely known. Research
subjects will be admitted to the Gastroenterology and Hepatology ward during
the study, with presence of experienced nurses and physicians.
Geert Grooteplein Zuid 10
Nijmegen 6525GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525GA
NL
Listed location countries
Age
Inclusion criteria
- Age >=18 years
- Indication for aspiration and sclerotherapy (large symptomatic liver cyst)
- Providing informed consent
Exclusion criteria
- History of hypersensitivity to multiple antibiotics, making it impossible to include the patient in one of two treatment groups.
- Use of other drugs with a contra-indication for antibiotic use, making it impossible to include the patient in one of two treatment groups.
- Presence of an arterio-venous fistula, history of mastectomy or lymph node dissection at both extremities.
- Signs of phlebitis, defined as localized skin redness and swelling, at both extremities
- Any current or prior medical condition that may interfere with the conduct of the study or the evaluation of its results in the opinion of the investigator.
- Severe renal impairment (eGFR < 30 ml/min/1,73 m2)
- Use of antibiotics that are going to be administered for the study in the 7 days before aspiration sclerotherapy.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2018-003262-13-NL |
| CCMO | NL67662.091.18 |
| Other | volgt |