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Brief title
Health condition
In this explorative pharmakinetics study, our aim is to assess tissue-penetration of antibiotics (ciprofloxacin, co-trimoxazole, doxycycline and piperacillin/tazobactam) into hepatic cysts, to guide therapy for hepatic cyst infections.
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 (ug/ml) to blood plasma concentration (ug/ml).
Secondary outcome
Day-curve plasma concentrations.
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. A previous proof-of-concept study showed no
cyst penetration of cefazolin. 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.
This explorative single-centre study will investigate the penetration of antibiotics into hepatic
cysts, to guide in clinical decision making when faced with spontaneous hepatic cyst
infection.
Study objective
Our hypothesis is that piperacillin/tazobactam, ciprofloxacin, co-trimoxazole and doxycycline are able to penetrate hepatic cysts.
Study design
Primary: at aspiration sclerotherapy
Secondary: every 1.5 hours after infusion. (6 times in total)
Intervention
Group 1: ciprofloxacin and piperacillin/tazobactam
Group 2: doxycycline and co-trimoxazole
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.
- 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
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7290 |
| NTR-old | NTR7499 |
| Other | EudraCT number : 2018-003262-13 |