MalariaNCT02793414
Diagnostic Utility of Volatile Organic Compounds in Human Breath for Acute Clinical Malaria in Ethiopia
An observational study of Malaria, run by Menzies School of Health Research.
Trial summary
This is a diagnostic efficacy study to evaluate a set of biomarkers in human breath indicative of an acute malaria infection. The investigators plan to enroll 75 malaria patients and 175 febrile non-malaria patients in Ethiopia. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Malaria
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Jan 2018
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Any participant above the age of 5 years fulfilling the inclusion criteria and attending the study hospital is eligible to participate in the study.
Malaria cohort
- Age ≥5 years of age
- Malaria microscopy and / or Malaria RDT confirmed malaria infection
- Fever (axillary temperature ≥37.5⁰C) or history of fever in preceding 48 hours
- Written informed consent Febrile controls
- Age ≥5 years of age
- Fever (axillary temperature ≥37.5⁰C) or history of fever in preceding 48 hours
- Absence of a malaria episode confirmed by malaria microscopy
- Written informed consent
About this study
This is a diagnostic efficacy study to evaluate a set of biomarkers in human breath indicative of an acute malaria infection. The investigators plan to enroll 75 malaria patients and 175 febrile non-malaria patients in Ethiopia.
Upon enrollment, blood for malaria RDT, microscopy and PCR will be collected as well as a breath sample to assess the presence of biomarkers at a reference center. Malaria patients identified by microscopy are revisited at day 2 and 7 to collect a further samples. G6PD testing will be performed concurrently to identify prevalent G6PD variants.
- Conditions
- Malaria
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Malaria patients | Not described | |
| Febrile controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of the VOC breathalyser
Sensitivity and specificity of the VOC breathalyser compared to microscopy, rapid diagnostic tests (RDTs) and PCR for the diagnosis of clinical malaria.
Measured: 7 days
Secondary outcomes (4)
Correlation of malaria parasite density with VOC concentrations
The correlation of malaria parasite density with VOC concentrations in patients with clinical and subpatent malaria and the recovery profile of VOC following acute malaria.
Measured: 7 days
G6PD variants
G6PD variants within the local population
Measured: 1 day
G6PD activity in U/gHb
The distribution of G6PD enzyme activity in the local population measured in U/gHb.
Measured: 1 day
Performance characteristics of qualitative and quantitative G6PD test formats.
Sensitivity and specificity of other G6PD diagnostic assays compared to the gold standard spectrophotometry
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study startSep 2016
- Primary completionApr 2017 (estimated)
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menzies School of Health Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02793414
- Sponsor's protocol ID
- VOCE
- Status last verified
- Oct 2020
- First submitted
- 26 May 2016
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Utility of Volatile Organic Compounds in Human Breath for Acute Clinical Malaria in Ethiopia
- ClinicalTrials.gov ID
- NCT02793414
- Acronym / sponsor ID
- VOCE
- Conditions
- Malaria
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Menzies School of Health ResearchUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Jan 2018 (actual)
- First posted
- 8 Jun 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.
This is a diagnostic efficacy study to evaluate a set of biomarkers in human breath indicative of an acute malaria infection. The investigators plan to enroll 75 malaria patients and 175 febrile non-malaria patients in Ethiopia.
Upon enrollment, blood for malaria RDT, microscopy and PCR will be collected as well as a breath sample to assess the presence of biomarkers at a reference center. Malaria patients identified by microscopy are revisited at day 2 and 7 to collect a further samples. G6PD testing will be performed concurrently to identify prevalent G6PD variants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Malaria patients | – | – |
| Febrile controls | – | – |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any participant above the age of 5 years fulfilling the inclusion criteria and attending the study hospital is eligible to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Performance of the VOC breathalyser
Time frame: 7 days
Sensitivity and specificity of the VOC breathalyser compared to microscopy, rapid diagnostic tests (RDTs) and PCR for the diagnosis of clinical malaria.
4 secondary outcomes
Correlation of malaria parasite density with VOC concentrations
Time frame: 7 days
G6PD variants
Time frame: 1 day
G6PD activity in U/gHb
Time frame: 1 day
Performance characteristics of qualitative and quantitative G6PD test formats.
Time frame: 1 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria, run by Menzies School of Health Research.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: withdrawn, as of the sponsor's last update on 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Performance of the VOC breathalyser (time frame: 7 days). 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 6 Oct 2020.