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Determining the tissue-penetration of antibiotics into liver cysts.


- candidate number29585
- NTR NumberNTR7499
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-sep-2018
- Secondary IDs2018-003262-13 EudraCT number
- Public TitleDetermining the tissue-penetration of antibiotics into liver cysts.
- Scientific TitleAn explorative study determining the hepatic cyst penetration of antibiotics (ciprofloxacin, co-trimoxazole, doxycycline and piperacillin/tazobactam) and factors affecting penetration.
- ACRONYMPENTAC 2
- hypothesisOur hypothesis is that piperacillin/tazobactam, ciprofloxacin, co-trimoxazole and doxycycline are able to penetrate hepatic cysts.
- Healt Condition(s) or Problem(s) studiedAntibiotics, Liver, Liver cyst
- 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.
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-jan-2019
- planned closingdate1-jan-2020
- Target number of participants20
- InterventionsGroup 1: ciprofloxacin and piperacillin/tazobactam
Group 2: doxycycline and co-trimoxazole
- Primary outcomeThe 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 outcomeDay-curve plasma concentrations.
- TimepointsPrimary: at aspiration sclerotherapy
Secondary: every 1.5 hours after infusion. (6 times in total)
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. dr. J.P.H. Drenth
- CONTACT for SCIENTIFIC QUERIESDrs. Lucas Bernts
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
Radboud University Medical Center Nijmegen
- Publications
- Brief summaryHepatic 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.
- Main changes (audit trail)
- RECORD25-sep-2018 - 17-okt-2018


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