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.
Conditions
Interventions
Group 1: ciprofloxacin and piperacillin/tazobactam
Group 2: doxycycline and co-trimoxazole
Sponsors
Radboud university medical center
Eligibility
Inclusion criteria
Inclusion criteria: - Age < 18 years - Indication for aspiration and sclerotherapy (large symptomatic liver cyst) - Providing informed consent
Exclusion criteria
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Day-curve plasma concentrations. | — |
Outcome results
None listed