Last updated: 11/03/2018 18:30:33

WEUKBRE5555: IMI PROTECT(Work Package 2): Liver injury & antibiotics

GSK study ID
115738
Clinicaltrials.gov ID
NCT01587768
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: WEUKBRE5555: IMI PROTECT (Work Package 2): The risk of acute liver injury associated with the use of antibiotics
Trial description: The studies described in this protocol are all performed within the framework of PROTECT (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium) Workpackage 2 (WP2) and Workgroup 1. The primary aim of these studies is to develop, test and disseminate methodological standards for the design, conduct and analysis of Pharmacoepidemiological (PE) studies applicable to different safety issues and using different data sources. To achieve this, results from PE studies on 5 key adverse events (AEs) performed in different databases will be evaluated. Therefore, emphasis will be on the methodological aspects of the studies in this protocol and not on the clinical consequences of the association under investigation. The standards to develop will contribute to decreasing the discrepancies in results from different studies in the future and increase the usefulness and reliability of these studies for benefit-risk assessment in the EU.
We propose to assess the association between antibiotics use and idiopathic acute liver injury with different study designs (descriptive, cohort, nested case-control and case crossover) across different primary care databases and to compare the results between databases, across designs to evaluate the impact of design/database/population differences on the outcome of the studied association.
Specific aims (in each database):
1. To describe characteristics, clinical features, and risk factors for acute liver injury in patients exposed and unexposed to antibiotics.
2. To estimate the overall risk of acute liver injury associated with antibiotics exposure (users and non-users) in each database
3. To estimate the risk of acute liver injury associated with various antibiotics classes
4. To estimate the risk of acute liver injury associated with specific individual antibiotics
5. To assess the effect of dose and duration of use for specific individual antibiotics.
6. To compare the results of a case-control study with the results of a retrospective cohort study and self-controlled case series study in the different databases
The proposed studies will be collected in populations from the following databases: The General Practice Research Database [GPRD] (UK), Health Improvement Network [THIN] (UK),
BIFAP [Base de datos Informatizada para estudios Farmacoepidemiologicos en Atencion Primaria] (Spain)– the Bavarian Claims Database (Germany), Mondriaan (Netherlands), and the National Databases of Denmark.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Idiopathic acute liver injury

Timeframe: Up to six years following drug exposure

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Antibiotic prescription during the study period between January 1, 2004 and December 31, 2009
    • Enrollment:
    1
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Infections, Bacterial
    Product
    amoxicillin, amoxicillin/clavulanic acid, ceftazidime, cefuroxime, cefuroxime axetil, clavulanic acid, flucloxacillin, ticarcillin, ticarcillin/clavulanic acid
    Collaborators
    Not applicable
    Study date(s)
    November 2011 to July 2014
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    No
    • Individuals with an active or died registration status d during the study period of January 1, 2004 to December 31, 2009
    • Individuals enrolled at least one year with the with the GP and having one year of computerized prescription history
    • Individuals with Read codes for idiopathic acute liver injury/disease, ICD-10 codes for Acute Liver injury, or CIAP codes for Idiopathic Acute Liver injury prior to start date
    • Individuals with one of the following diagnoses prior to the start date: cancer, alcoholism, alcohol related problems, gallbladder disease, pancreatic disease, and other chronic liver diseases.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Individuals with an active or died registration status d during the study period of January 1, 2004 to December 31, 2009
    • Individuals enrolled at least one year with the with the GP and having one year of computerized prescription history
    Exclusion criteria:
    • Individuals with Read codes for idiopathic acute liver injury/disease, ICD-10 codes for Acute Liver injury, or CIAP codes for Idiopathic Acute Liver injury prior to start date
    • Individuals with one of the following diagnoses prior to the start date: cancer, alcoholism, alcohol related problems, gallbladder disease, pancreatic disease, and other chronic liver diseases.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    No study documents available

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2014-30-07

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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