Malaria DiagnosisVZNIGHTNCT02700269
Vanderbilt-Zambia Innovations in Global Health Technologies
An observational study of Malaria Diagnosis, run by Macha Research Trust, Zambia at 1 site in Zambia.
Trial summary
Investigators will evaluate approaches using magnetic bead capture, isolation, and surface tension valve transfer of biomarkers to process capillary blood in order to improve the sensitivity of already approved Rapid Diagnostic Tests (RDTs) for detection of human malaria infection. Read more about this study
- Who is it for?
- Ages 6 months to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria Diagnosis
- What is being tested?
- mBEADS
- How many people
- 278 participants
- Where
- 1 siteZambia
- Study dates
- Apr 2016to Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 6 months to 85 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Those seeking care for suspected malaria in Zambia
Who may be able to join
- Individuals giving written informed consent for themselves
- Children under the age of 18 for whom a parent or guardian can give consent
- Individuals seeking care or treatment of suspected or possible malaria
- Individuals being screened as a contact of someone with recent malaria
- Other individuals willing to have their blood tested for malaria
Who cannot join
- Anyone over 18 unwilling or unable to provide informed consent
- Anyone under 18 who does not have a parent or guardian to give consent
- Anyone between the age of 12 and 18 who does not give assent
Trial locations and contacts
1 site in 1 country.
About this study
Investigators will evaluate approaches using magnetic bead capture, isolation, and surface tension valve transfer of biomarkers to process capillary blood in order to improve the sensitivity of already approved Rapid Diagnostic Tests (RDTs) for detection of human malaria infection. Results will be compared to those obtained using unenhanced capillary blood specimens directly applied to approved malaria RDTs. Participants seeking care for possible malaria in Zambia will be recruited to enroll in the study.
- Conditions
- Malaria Diagnosis
- Being tested
- mBEADS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mBEADSOther
Evaluate approaches using magnetic bead capture, isolation, and surface tension valve transfer of biomarkers to improve the sensitivity of already approved malaria RDTs.
What is being measured
The primary outcome is the main question the study is designed to answer.
Enhancement of malaria RDT to detect low levels of P falciparum parasites
The expected outcome of this research project is to enhance the ability of standard malaria RDTs to detect low levels of Plasmodium falciparum malaria in human capillary blood.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionFeb 2019
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malaria DiagnosisStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Macha Research Trust, Zambia
- Sponsor type
- University, hospital or other
- Collaborators
- Vanderbilt University, National Institutes of Health (NIH), Fogarty International Center of the National Institute of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02700269
- Sponsor's protocol ID
- MRT15003.2
- Other IDs
- 5D43TW009348
- Acronym
- VZNIGHT
- Status last verified
- Feb 2020
- First submitted
- 25 Feb 2016
- Last updated
- 19 Feb 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vanderbilt-Zambia Innovations in Global Health Technologies
- ClinicalTrials.gov ID
- NCT02700269
- Acronym / sponsor ID
- VZNIGHT / MRT15003.2
- Conditions
- Malaria Diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Macha Research Trust, ZambiaUniversity, hospital or other
- Collaborators
- Vanderbilt University, National Institutes of Health (NIH), Fogarty International Center of the National Institute of Health
- Study start
- Apr 2016 (actual)
- Primary completion
- Feb 2019 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 7 Mar 2016 (estimated)
- 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.
Investigators will evaluate approaches using magnetic bead capture, isolation, and surface tension valve transfer of biomarkers to process capillary blood in order to improve the sensitivity of already approved Rapid Diagnostic Tests (RDTs) for detection of human malaria infection. Results will be compared to those obtained using unenhanced capillary blood specimens directly applied to approved malaria RDTs. Participants seeking care for possible malaria in Zambia will be recruited to enroll in the study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 months to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Those seeking care for suspected malaria in Zambia
Key inclusion criteria (5 listed)
- Individuals giving written informed consent for themselves
- Children under the age of 18 for whom a parent or guardian can give consent
- Individuals seeking care or treatment of suspected or possible malaria
- Individuals being screened as a contact of someone with recent malaria
- Other individuals willing to have their blood tested for malaria
Key exclusion criteria (3 listed)
- Anyone over 18 unwilling or unable to provide informed consent
- Anyone under 18 who does not have a parent or guardian to give consent
- Anyone between the age of 12 and 18 who does not give assent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mBEADSEvaluate approaches using magnetic bead capture, isolation, and surface tension valve transfer of biomarkers to improve the sensitivity of already approved malaria RDTs. | Other | – |
Primary outcome
Enhancement of malaria RDT to detect low levels of P falciparum parasites
Time frame: 5 years
The expected outcome of this research project is to enhance the ability of standard malaria RDTs to detect low levels of Plasmodium falciparum malaria in human capillary blood.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria Diagnosis, run by Macha Research Trust, Zambia at 1 site in Zambia.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enhancement of malaria RDT to detect low levels of P falciparum parasites (time frame: 5 years). 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 19 Feb 2020.