Wearable Biosensors for Malaria Detection

KL
Overseen ByKirsten Lyke, MD

What You Need to Know Before You Apply

What is the purpose of this trial?

In order to control infections, the investigators must first detect them. Biosensor devices may allow early detection and intervention for infectious diseases, helping the investigators to recognize infections early, and allow for early treatment. This will lower transmission of infections and lower costs for treating someone who becomes ill. This is a study testing whether a wearable device such as a wristband and/or earphones can measure early biologic signals to detect identify infection in prior to seeing symptoms related of a disease. As a first test of this technology, the investigators will expose participants to injectable malaria or placebo. This is called a "Controlled Human Malaria Infection" (CHMI). Everyone who takes part in the CHMI may get malaria infection. The investigators will detect malaria using standard blood tests. The investigators will also look for early symptoms of malaria infection like changes in temperature, heart rate, breathing, sleep patterns, and changes in skin and muscle activity or voice. These signals may allow the investigators to detect early malaria infection. This is a study testing whether a wearable device such as a wristband and/or earphones can measure early biologic signals to detect malaria infection before symptoms occur, as confirmed by standard blood testing.

Are You a Good Fit for This Trial?

Inclusion Criteria

I am not required to use contraception if my partner is the same sex and this is my usual lifestyle.
I am a male or a non-pregnant, non-breastfeeding female between 18 and 50 years old.
2. Participants must be able to provide written informed consent.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Controlled Human Malaria Infection (CHMI)

Participants are exposed to injectable malaria or placebo to test the biosensor devices for early detection of malaria infection.

8 weeks
Multiple visits for monitoring and data collection

Follow-up

Participants are monitored for safety and effectiveness after exposure to malaria infection.

8 weeks
Regular visits for blood tests and symptom monitoring

What Are the Treatments Tested in This Trial?

Interventions

  • PfSPZ Challenge (NF54)

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: PfSPZ ChallengeExperimental Treatment2 Interventions
Group II: PlaceboPlacebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials
729
Recruited
540,000+

Bill and Melinda Gates Foundation

Collaborator

Trials
428
Recruited
23,060,000+

Sanaria Inc.

Industry Sponsor

Trials
38
Recruited
3,700+

University of Texas at Austin

Collaborator

Trials
387
Recruited
86,100+