Last updated: 03/13/2026 12:50:20
ALDREB Drug Use Investigation
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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:
Not applicable
Observational study model:
Case-Only
Primary completion date:
2023-24-01
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 January 2023
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)
No location data available.
Study documents
Study report synopsis
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2023-24-01
Actual study completion date
2023-24-01
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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