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Therapeutic Drug Monitoring and Continuous Infusion of Beta-lactam Antibiotics in Patients With Bacteraemia

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ClinicalTrials.gov Identifier: NCT03108690
Recruitment Status : Unknown
Verified August 2017 by Sara Thønnings, Hvidovre University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : April 11, 2017
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
Sara Thønnings, Hvidovre University Hospital

Brief Summary:
The study investigates whether Therapeutic Drug Monitoring (TDM) and continuous infusion (CI) of beta-lactam antibiotics optimises target concentrations in patients with bacteraemia.

Condition or disease Intervention/treatment Phase
Bacteremia Drug: Continuous infusion of beta-lactam antibiotics . Other: Therapeutic drug monitoring of beta-lactam antibiotics. Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Therapeutic Drug Monitoring and Continuous Infusion of Beta-lactam Antibiotics in Patients With Bacteraemia
Estimated Study Start Date : September 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: TDM and CI.
Continuous infusion of beta-lactam antibiotics. Therapeutic drug monitoring of beta-lactam antibiotics.
Drug: Continuous infusion of beta-lactam antibiotics .
Beta-lactam antibiotic will be administered as continous infusion.
Other Names:
  • Benzylpenicillin
  • Ampicillin
  • Dicloxacillin
  • Piperacillin/tazobactam
  • Cefuroxime
  • Meropenem

Other: Therapeutic drug monitoring of beta-lactam antibiotics.
Dosage of beta-lactam antibiotics will be adjusted according to serum concentration.

No Intervention: Control
Beta-lactam antibiotics given as intermittent infusion. Samples of serum concentration of beta-lactam will be collected for comparison, but blinded during the study.



Primary Outcome Measures :
  1. Target concentrations. [ Time Frame: 30 days after intervention. ]
    Serum concentrations within the target values for intervention. Following beta-lactams is included in the study: Benzylpenicillin, ampicillin, dicloxacillin, piperacillin/tazobactam, cefuroxime and meropenem.


Secondary Outcome Measures :
  1. Morbidity. [ Time Frame: 30 days after intervention. ]
    Diagnoses compared between the two arms.

  2. Number of days until medically discharged. [ Time Frame: 30 days after intervention. ]
    Number of days until medically discharged compared between the two arms.

  3. Failed antibiotic treatments. [ Time Frame: 30 days after intervention. ]
    Adding an additional antibiotic and/or change to a different antibiotic (not including a more narrow spectrum antibiotic) compared between the two arms.

  4. Amount of antibiotic used. [ Time Frame: 30 days after intervention. ]
    Defined daly doses of antibiotic therapy compared between the two arms.

  5. Antibiotic side effects and complications. [ Time Frame: 30 days after intervention. ]
    The severity of bacteraemia, mechanical ventilation and start-up of dialysis compared between the two arms. Growth of antibiotic-associated pathogenic in patient material compared between the two arms.

  6. Mortality. [ Time Frame: 30 days after intervention. ]
    30-day mortality compared between the two arms.

  7. Number of participants with abnormal clinical data and/or abnormal laboratory values. [ Time Frame: 30 days after intervention. ]
    Clinical data includes height, weight, heart rate, blood pressure, respiratory rate, Glasgow Coma Scale score, body temperature, fous of infection, the severity of bacteraemia, dialysis and laboratory values includes hemoglobin, white blood cells, neutrophils, thrombocytes, C-reactive protein, sodium, potassium, creatinine, albumin, lactate dehydrogenase, alanine amino transferase and lactate. Both will be compared between the two arms.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a positive blood culture.
  • Undergo treatment with either intravenous penicillin, ampicillin, piperacillin/tazobactam, dicloxacillin, cefuroxime or meropenem.
  • Hospitalised at Hvidovre University Hospital.
  • Age ≥ 18.
  • Able to understand and give informed consent.
  • Included in the study within 24 hours after the final positive blood culture answer.

Exclusion Criteria:

  • Positive blood culture is interpreted as contamination.
  • The patient dies before the intervention.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03108690


Contacts
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Contact: Sara Thønnings, MD +45 38621783 sara.thoennings@regionh.dk

Sponsors and Collaborators
Sara Thønnings
Investigators
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Principal Investigator: Sara Thønnings, MD Hvidovre University Hospital

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Responsible Party: Sara Thønnings, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT03108690     History of Changes
Other Study ID Numbers: 2015-768
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Sara Thønnings, Hvidovre University Hospital:
Therapeutic drug monitoring
Continuous infusion
Beta-lactam
Antibiotics
Bacteraemia

Additional relevant MeSH terms:
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Bacteremia
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Anti-Bacterial Agents
Piperacillin
Piperacillin, Tazobactam Drug Combination
Lactams
beta-Lactams
Dicloxacillin
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action