Infections, Bacterial Clinical Trial
Official title:
WEUKBRE5555: IMI PROTECT (Work Package 2): The Risk of Acute Liver Injury Associated With the Use of Antibiotics
Verified date | December 2014 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: No Health Authority |
Study type | Observational |
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.
Status | Completed |
Enrollment | 1 |
Est. completion date | July 2014 |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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. |
Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Idiopathic acute liver injury | Idiopathic acute liver injury, defined at least with one of the following conditions (A+B or A+C): A - A diagnosis of liver injury (codes listed in tables 1a, 1b, 1c) with a referral to a specialist or hospital. Together with B - An increase of more than two times the upper limit of the normal range in alanine aminotransferase (ALT) or C - A combined increase in aspartate aminotransferase (AST), alkaline phosphatase (AP) and total bilirubin provided one of them is twice the upper limit of the respective normal range. | Up to six years following drug exposure | Yes |
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