Last updated: 10/31/2023 10:20:15
Amazon health surveillance using Seta technology
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A six-month observational study of a new health surveillance technology to enhance safety monitoring at two sites in the Amazon region during the TRuST study (Protocol N° MMV_TQ_18_02 )
Trial description: Spontaneous safety reporting rates are generally low in malaria public health facilities in the Amazon. The SETA technology is designed to facilitate health and safety surveillance. To optimize the operational effectiveness of the SETA technology, a six-month pilot implementation project is proposed in the Amazon region in Brazil. The intention of conducting the SETA pilot during the conduct of the TRuST study is to offer potential enhanced safety monitoring of the feasibility assessment of the introduction of tafenoquine, a new anti-malarial, combined with glucose-6-phosphate dehydrogenase (G6PD) testing into the management of Plasmodium vivax (P vivax) malaria in the Amazon region. Adult participants participating in the TRuST study will be invited to participate in active surveillance for 6 months regardless of which anti-malarial they are prescribed.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of adverse events (AEs) reported to Agencia Nacional de Vigilancia Sanitaria (ANVISA) over 6 months
Timeframe: Up to 6 months
Secondary outcomes:
Number of AEs reported to ANVISA per month
Timeframe: Monthly up to 6 months
Interventions:
Not applicable
Enrollment:
158
Primary completion date:
2022-26-10
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Vivax Malaria
Product
tafenoquine
Collaborators
Not applicable
Study date(s)
July 2022 to October 2022
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Participants 18 years of age or older.
- Participants in the TRuST study receiving treatment for malaria.
- None
Inclusion and exclusion criteria
Inclusion criteria:
- Participants 18 years of age or older.
- Participants in the TRuST study receiving treatment for malaria.
- Participants who have access to a smart phone.
- Participants who have WhatsApp downloaded and are familiar with its use.
- Participants with consent for their personal contact details to be held confidentially and securely in the SETA database and to receive WhatsApp notifications and phone calls from the pharmacovigilance co-ordinator (PVC) if appropriate.
Exclusion criteria:
- None
Trial location(s)
Location
GSK Investigational Site
Porto Velho, Rondônia, Brazil, 76812-329
Status
Study Complete
Study documents
Protocol
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
Study complete
Actual primary completion date
2022-26-10
Actual study completion date
2022-31-10
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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