Dengue - Sample Collection Study Pakistan | NCT07203183

Studies
Dengue - Sample Collection Study Pakistan

NCT07203183

Sponsor

Abbott Rapid Dx

Status

Not yet recruiting

Last Update Posted

Oct 2, 2025Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Dengue

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2025Estimated

Primary Completion Date

Mar 1, 2026Estimated

Completion Date

Apr 1, 2026Estimated

First Submitted Date

Sep 24, 2025

First Submission Date that Met QC Criteria

Sep 24, 2025

First Posted Date

Oct 2, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 24, 2025

Last Update Posted Date

Oct 2, 2025Actual

Name	Class
Aga Khan University	OTHER
National University of Medical Sciences, Pakistan	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Estimated

Measure	Description	Time Frame
sample collection only, no specific outcome needed		5 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Subjects with symptoms suggestive of active dengue or a recent diagnosis of dengue seeking clinical care.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Simon Kordowich, PHD	Contact	+353 (0)91 429 900		info@abbott.com
Jocelyn Farge, MSc, MBA	Contact	+353 (0)91 429 900		info@abbott.com

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003715	Dengue

Ancestor Terms

ID	Term
D000096724	Mosquito-Borne Diseases
D000079426	Vector Borne Diseases
D007239	Infections
D001102	Arbovirus Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
dengue positives
dengue negatives