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NCT07558122 · ClinicalTrials.gov registry record · Phase 1
Malaria CVD 36000; Gates INV090205
A Phase 1 study, sponsored by University of Maryland, Baltimore.
- Not yet
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT07558122: Clinical Trial Phase 1 study, sponsored by University of Maryland, Baltimore.
NCT07558122 is a Phase 1 study that has not yet begun recruiting, run by University of Maryland, Baltimore. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07558122, a Phase 1 study, has not yet begun recruiting, sponsored by University of Maryland, Baltimore.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Presence or absence of RT-qPCR through Day 28 (unit - Ct value)
Interventions
- OTHER Placebo
- BIOLOGICAL PfSPZ Challenge (NF54)
- DEVICE Wearable Biosensor Devices
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2026-06-13 |
| Est. Completion | 2026-08 |
| Phase | Phase 1 |
What is known before NCT07558122 opens enrollment
NCT07558122 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT07558122 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07558122 about?
NCT07558122 is a clinical study titled "Malaria CVD 36000; Gates INV090205". 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...
What is the current status of trial NCT07558122?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2026-06-13. Estimated completion is 2026-08.
What interventions are being tested in trial NCT07558122?
The interventions under investigation include: Placebo (OTHER), PfSPZ Challenge (NF54) (BIOLOGICAL), Wearable Biosensor Devices (DEVICE).
Who is sponsoring clinical trial NCT07558122?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07558122's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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