Innovation Platform | NCT04558528

Studies
Innovation Platform

NCT04558528

Sponsor

Foundation for Innovative New Diagnostics, Switzerland

Status

Completed

Last Update Posted

Nov 18, 2023Actual

Enrollment

640Actual

Phase

Not provided

Conditions

Malaria

Interventions

Novel in vitro diagnostics and medical applications

Countries

Indonesia
Rwanda

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

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2020Actual

Primary Completion Date

Jul 31, 2021Actual

Completion Date

Jul 31, 2021Actual

First Submitted Date

Sep 15, 2020

First Submission Date that Met QC Criteria

Sep 21, 2020

First Posted Date

Sep 22, 2020Actual

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

Nov 15, 2023

Last Update Posted Date

Nov 18, 2023Actual

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

In this study, a prospective evaluation of novel malaria diagnostic tools under development will be performed in malaria-endemic countries to assess their clinical performance for detection of malaria at point-of-care (POC). This study aims to support product development efforts and aims to provide early stage (TLR~5) technology developers with valuable information on performance and basic feasibility data that can help to accelerate 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

No data available

No data is available for this block.

Enrollment

640Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Novel in vitro diagnostics and medical applications	Diagnostic Test	Novel in vitro diagnostics and medical applications

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical performance assessment	Point estimates of clinical performance characteristics with 95% confidence intervals (sensitivity, specificity, NPV, PPV, and DOR) of nPOC using nPCR as reference for detecting malaria in patients with symptoms suggestive of malaria	up to 6 months
Concordance	Point estimate with 95% confidence intervals of the percentage agreement in interpreting malaria diagnostics between the app and visual reading	up to 6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged 5 years or older
Presenting at the study site with symptoms and signs suggestive of malaria
Freely agreeing to participate by signing an informed consent form (adults aged 18 and older and parent/legal guardian of a child) and providing assent (children aged 13-17)
Willing to provide sample at enrolment

Exclusion Criteria:

Presence of symptoms and signs of severe disease and/or central nervous system infections, as defined by WHO guidelines

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with symptoms suggestive of malaria seeking clinical care in health facilities

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Eijkman Institute for Molecular Biology		Jakarta		10430	Indonesia
Stansile

Condition Browse Module

MeSH Terms

ID	Term
D008288	Malaria

Ancestor Terms

ID	Term
D011528	Protozoan Infections
D010272	Parasitic Diseases
D007239	Infections
D000096724	Mosquito-Borne Diseases

Browse Leaves

Not provided

Browse Branches

Not provided