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Temocillin Pharmacokinetics in Paediatrics (TEMOPEDI)

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ClinicalTrials.gov Identifier: NCT02260102
Recruitment Status : Recruiting
First Posted : October 9, 2014
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
Paul M. Tulkens, Université Catholique de Louvain

Brief Summary:
Temocillin (6-methoxy-ticarcillin) is a beta-lactam antibiotic with exceptional resistance to most beta-lactamases. In this context, it is now increasingly used as carbapenem-sparing antibiotic in patients with suspected infection by Enterobactreriaceae suspected to produce extended-spectrum beta-lactamases. Little is known about dosing and elimination of temocillin in children. While available literature of temocillin use in paediatrics refers mainly to its clinical efficacy in the treatment of urinary tract infections, the drug is also used for the treatment of suspicion of cholangitis in cirrhotic paediatric patients, and as antibiotic prophylaxis following an hepatic transplant in children (both off-label indications). There is, therefore, a pressing need to explore the pharmacokinetics and pharmacodynamics of temocillin in the paediatric population, in order to provide clear guidance on an appropriate dosing regimen. The study objectives are: (1) characterisation of the pharmacokinetics (PK) of temocillin in 3 paediatric populations, (2) proposal and development of a dosing schedule that can ensure therapeutic concentrations (40% ƒT > MIC) and optimize treatment chances of success, and (3) characterization of MICs of microbiological strains (when available) to temocillin.

Condition or disease Intervention/treatment Phase
Infection Liver Dysfunction Urinary Tract Infection Drug: Temocillin Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Temocillin Pharmacokinetics in Paediatrics
Actual Study Start Date : February 17, 2016
Estimated Primary Completion Date : October 31, 2018
Estimated Study Completion Date : October 31, 2019

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Arm Intervention/treatment
Active Comparator: urinary tract infections
Children requiring antibiotic treatment for urinary tract infections. Intervention: blood sampling for assay of temocillin
Drug: Temocillin
Venous blood will be drawn (as per the protocol) for assay of temocillin on day 1 and day 4 of treatment. This is not part of our standard of care and is, therefore, an intervention. Patients are enrolled only if receiving temocillin as part of their normal standard of care (and the drug will be administered based on current recommendations [no change due to enrollment in the study]).
Other Name: NEGABAN

Active Comparator: cholangitis

Cirrhotic children requiring antibiotic treatment due to suspicion of cholangitis.

Intervention: blood sampling for assay of temocillin

Drug: Temocillin
Venous blood will be drawn (as per the protocol) for assay of temocillin on day 1 and day 4 of treatment. This is not part of our standard of care and is, therefore, an intervention. Patients are enrolled only if receiving temocillin as part of their normal standard of care (and the drug will be administered based on current recommendations [no change due to enrollment in the study]).
Other Name: NEGABAN

Active Comparator: hepatic transplant
Children requiring antibiotic prophylaxis following a hepatic transplant. Intervention: blood sampling for assay of temocillin
Drug: Temocillin
Venous blood will be drawn (as per the protocol) for assay of temocillin on day 1 and day 4 of treatment. This is not part of our standard of care and is, therefore, an intervention. Patients are enrolled only if receiving temocillin as part of their normal standard of care (and the drug will be administered based on current recommendations [no change due to enrollment in the study]).
Other Name: NEGABAN




Primary Outcome Measures :
  1. Serum levels of temocillin [ Time Frame: 18 months ]
    Characterisation of the pharmacokinetics (PK) of temocillin (total and free concentrations) in the 3 paediatric populations included



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Ages Eligible for Study:   6 Months to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patient requiring temocillin

    1. for the treatment of urinary tract infections, or
    2. for the treatment of suspicion of cholangitis associated with cirrhosis, or
    3. as antibiotic prophylaxis following an hepatic transplant.
  • patient requiring hospitalization (not for social or other non-medical reasons) for at least up to 5 days
  • Parents or legal representatives able to give written informed consent in accordance with GCP and local regulatory requirements, prior to any study procedure

Exclusion Criteria:

  1. Ig-E mediated allergy to penicillins
  2. Previous treatment with temocillin for the current cholangitis episode
  3. Diagnosis of Alagille syndrome
  4. Estimated life-expectance of < 5 days due to major co-morbid conditions
  5. Other serious illnesses, e.g. HIV, serious infections requiring other antibiotics, malignancy
  6. Patients with acute or chronic renal failure (eGFR < 30ml/min)
  7. Patients having participated in another study < 30 days before inclusion in the present study

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): NCT02260102


Contacts
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Contact: Paul M Tulkens, MD, PhD +32-2-762*-2136 tulkens@facm.ucl.ac.be
Contact: Françoise Van Bambeke, PharmD, PhD +32-2-764-7378 francoise.vanbambeke@uclouvain.be

Locations
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Belgium
Cliniques universitaires St-Luc Recruiting
Bruxelles, Belgium, B1200
Contact: Etienne Sokal, MD    0113227641386    etienne.sokal@uclouvain.be   
Contact: Xavier Stephenne, MD    0113227641387    xavier.stephenne@uclouvain.be   
Sponsors and Collaborators
Université Catholique de Louvain
Investigators
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Study Director: Françoise Van Bambeke, PharmD, PhD Université Catholique de Louvain

Additional Information:
Publications:
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Responsible Party: Paul M. Tulkens, Invited Professor, Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT02260102     History of Changes
Other Study ID Numbers: temocillin-pediatrics
First Posted: October 9, 2014    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Liver Diseases
Urologic Diseases
Digestive System Diseases
Temocillin
Penicillins
Anti-Bacterial Agents
Anti-Infective Agents