DengueNCT07203183
Dengue - Sample Collection Study Pakistan
An observational study of Dengue, run by Abbott Rapid Dx.
Trial summary
The objective of this study is to collect well-characterized serum and plasma specimens from confirmed dengue positive and dengue negative subjects to support dengue diagnostic products development. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dengue
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Subjects with symptoms suggestive of active dengue or a recent diagnosis of dengue seeking clinical care.
Who may be able to join
- Age ≥12-years-old
- Individuals suspected or confirmed for active dengue, with dengue-consistent symptoms onset up to and including 10 days before enrolment in this trial.
Who cannot join
- Subject has been vaccinated for dengue.
- Subject participates in an investigative drug, vaccine or medical device clinical study
- Participant is deemed unfit for the study by the Investigator
- Participant is unwilling or unable to provide informed consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective Study for the Collection of Whole Blood Samples to Support the Development and Validation of In Vitro Diagnostic Tests for Dengue
The objective of this study is to collect well-characterized serum and plasma specimens from confirmed dengue positive and dengue negative subjects to support dengue diagnostic products development.
- Conditions
- Dengue
- Keywords
- dengue, sample collection, serum, plasma, blood
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| dengue positives | Not described | |
| dengue negatives | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
sample collection only, no specific outcome needed
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DengueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Rapid Dx
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aga Khan University, National University of Medical Sciences, Pakistan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07203183
- Sponsor's protocol ID
- SDRD-K-029-P
- Status last verified
- Sep 2025
- First submitted
- 24 Sep 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study for the Collection of Whole Blood Samples to Support the Development and Validation of In Vitro Diagnostic Tests for Dengue
- ClinicalTrials.gov ID
- NCT07203183
- Acronym / sponsor ID
- SDRD-K-029-P
- Conditions
- Dengue
- Keywords
- dengue, sample collection, serum, plasma, blood
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Abbott Rapid DxIndustry (pharma, biotech, devices)
- Collaborators
- Aga Khan University, National University of Medical Sciences, Pakistan
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 2 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to collect well-characterized serum and plasma specimens from confirmed dengue positive and dengue negative subjects to support dengue diagnostic products development.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dengue positives | – | – |
| dengue negatives | – | – |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects with symptoms suggestive of active dengue or a recent diagnosis of dengue seeking clinical care.
Key inclusion criteria (2 listed)
- Age ≥12-years-old
- Individuals suspected or confirmed for active dengue, with dengue-consistent symptoms onset up to and including 10 days before enrolment in this trial.
Key exclusion criteria (4 listed)
- Subject has been vaccinated for dengue.
- Subject participates in an investigative drug, vaccine or medical device clinical study
- Participant is deemed unfit for the study by the Investigator
- Participant is unwilling or unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
sample collection only, no specific outcome needed
Time frame: 5 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Dengue, run by Abbott Rapid Dx.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simon Kordowich, PHD (+353 (0)91 429 900, info@abbott.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sample collection only, no specific outcome needed (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.