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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06363890




Registration number
NCT06363890
Ethics application status
Date submitted
9/04/2024
Date registered
12/04/2024
Date last updated
13/08/2024

Titles & IDs
Public title
Etiology of Travelers' Diarrhea in Australian Tourists Traveling to Southeast Asia
Scientific title
Frequency and Etiology of Travelers' Diarrhea in Australian Adult Tourists Traveling to Southeast Asia
Secondary ID [1] 0 0
TD02
Universal Trial Number (UTN)
Trial acronym
AusTD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Travelers Diarrhea 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Diagnosis / Prognosis - TAQMan Array Card

Adult Australian travelers - 1200 Healthy Australian adult tourists traveling to Southeast Asia.


Diagnosis / Prognosis: TAQMan Array Card
Real time PCR test to detect diarrheal pathogens.
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Characterize the frequency and etiology of travelers' diarrhea in this participant population of Australian adult tourists traveling to Southeast Asia.
Timepoint [1] 0 0
18 months

Eligibility
Key inclusion criteria
* Adult aged > 18 years residing in Australia.
* Planned travel for 14 to 28 days starting in the next 30 days to selected countries in Southeast Asia, including Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Thailand, Timor-Leste, and Vietnam.
* Willing to participate in the clinical study and available for all planned study activities through approximately 28 days post-travel.
* Access to a smartphone and mobile phone services while traveling (either by local SIM card, WiFi, or international roaming service on the individual's home-country mobile phone).
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Unable or unwilling to provide adequate informed consent.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/06/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
1200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
AK Clinical Research - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Lumen Bioscience, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The study proposed here will determine the frequency and etiology of diarrhea in Australian adult tourists traveling to Southeast Asia, including Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Thailand, Timor-Leste, and Vietnam. The results from this study will inform the feasibility and design of subsequent clinical trials of travelers' diarrhea interventions in this population.
Trial website
https://clinicaltrials.gov/study/NCT06363890
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Carl Mason, MD
Address 0 0
Country 0 0
Phone 0 0
2068991904
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06363890