Last updated: 01/23/2024 18:00:18

ALDREB Drug Use Investigation

GSK study ID
201275
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruiting
Recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: ALDREB Drug Use Investigation
Trial description: This post-marketing surveillance (PMS) study is conducted to collect safety and effectiveness data in all subjects who are administered colistin sodium methanesulfonate according to the prescribing information in the locally approved label by the authorities. ALDREB is a trademark of the GlaxoSmithKline group of companies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

The incidence of adverse drug reactions

Timeframe: From the start of administration to the end/withdrawal

Secondary outcomes:
Not applicable
Interventions:
  • Drug: colistin sodium methanesulufonate
    • Enrollment:
    200
    Primary completion date:
    2024-25-12
    Observational study model:
    Case-Only
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Infections, Pseudomonas, Multiple Drug Resistant
    Product
    GW402007
    Collaborators
    Not applicable
    Study date(s)
    August 2015 to December 2024
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    Not applicable
    • All subjects administered colistin sodium methanesulfonate
    • None
    Inclusion and exclusion criteria
    Inclusion criteria:
    • All subjects administered colistin sodium methanesulfonate
    Exclusion criteria:
    • None

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Protocol
    Available language(s): English
    Download document(s)
    Statistical analysis plan
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Recruiting
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    Plain language summaries

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

    Additional information about the trial

    Additional information
    Not applicable
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