Plasmodium Knowlesi InfectionNCT03988296
Molecular Diagnostic Methods for Detection of Plasmodium Knowlesi
An observational study of Plasmodium Knowlesi Infection, run by Duke University at 3 sites in Malaysia.
Trial summary
This study aims to determine the sensitivity, specificity, and practical value of two new molecular diagnostic assays compared to a more classical nested molecular diagnostic assay and the routine microscopy (both of which are the current gold standard) in detection of P. knowlesi. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Plasmodium Knowlesi Infection
- How many people
- 116 participants
- Where
- 3 sitesMalaysia
- Study dates
- 11 Jun 2019to 22 Aug 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 7 years and older
- All sexes
- Child, Adult, Older adult
Study population: Both adults and children > 7 years old suspected for malaria and meeting inclusion criteria will be eligible to participate. Study subjects will be enrolled at Sarawak Hospitals, both hospitalized and outpatients, using an informed consent process (or assent for children 7-18 years) that permits the completion of a brief questionnaire and collection of a blood sample.
Who may be able to join
- Suspected for malaria infection; fever (axillary or tympanic temperature ≥ 37.5 °C or oral or rectal temperature of ≥ 38 °C) with chills, worsening malaise, headache lassitude, fatigue, abdominal discomfort, muscle and joint aches, anorexia, perspiration, or vomiting at the time of evaluation or within the past 48 hours
- Written informed consent is obtained.
- For Children (>7 to <18 years): parent or legal guardian provides written informed consent.
Who cannot join
- Patients living in, or returning from malaria endemic area outside of Sarawak within 2 weeks of illness onset
- They have a clear alternative diagnosis other than malaria by a trained health care professional.
Trial locations and contacts
3 sites in 1 country.
Malaysia3 sites
Kapit Hospital
Kapit, Sarawak, 96800
Sarikei Hospital
Sarikei, Sarawak, 96100
Sibu Hospital
Sibu, Sarawak, 96000
About this study
Official title: Adapting Novel Molecular Diagnostic Methods for Detection of Plasmodium Knowlesi in Sarawak, Malaysia
This study aims to determine the sensitivity, specificity, and practical value of two new molecular diagnostic assays compared to a more classical nested molecular diagnostic assay and the routine microscopy (both of which are the current gold standard) in detection of P. knowlesi.
- Conditions
- Plasmodium Knowlesi Infection
- Keywords
- Monkey malaria
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with a possible diagnosis of malaria
Possible diagnosis of malaria as defined in accordance with the inclusion and exclusion criteria. Giemsa-stained thick and thin smears will be prepared for verification of parasitaemia by microscopy in the respective hospital laboratories
Measured: 10 weeks
Secondary outcomes (1)
Statistical association between risk factors and diagnostic assays results.
A brief enrollment questionnaire will be used to determine a statistical association between demographic and behavioral/occupational risk factors and the assays results combined
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study start11 Jun 2019
- Primary completion22 Aug 2019
- Study completion22 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Plasmodium Knowlesi InfectionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory C. Gray, MD, Principal investigator, Duke University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03988296
- Sponsor's protocol ID
- Pro00102072
- Status last verified
- Jun 2019
- First submitted
- 13 Jun 2019
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Subjects' anonymity will be maintained and confidentiality of records and documents that could identify subjects will be protected, respecting the privacy and confidentiality rules in accordance with applicable regulatory requirements. Only the site principle investigators will be able to backlink the study data to the patient's medical record.
Publications
Richards J, Mueller I. Identifying the risks for human transmission of Plasmodium knowlesi. Lancet Planet Health. 2017 Jun;1(3):e83-e85. doi: 10.1016/S2542-5196(17)30053-0. Epub 2017 Jun 9. No abstract available.
PubMed 29851611Imai N, White MT, Ghani AC, Drakeley CJ. Transmission and control of Plasmodium knowlesi: a mathematical modelling study. PLoS Negl Trop Dis. 2014 Jul 24;8(7):e2978. doi: 10.1371/journal.pntd.0002978. eCollection 2014 Jul.
PubMed 25058400Singh B, Daneshvar C. Human infections and detection of Plasmodium knowlesi. Clin Microbiol Rev. 2013 Apr;26(2):165-84. doi: 10.1128/CMR.00079-12.
PubMed 23554413Singh B, Kim Sung L, Matusop A, Radhakrishnan A, Shamsul SS, Cox-Singh J, Thomas A, Conway DJ. A large focus of naturally acquired Plasmodium knowlesi infections in human beings. Lancet. 2004 Mar 27;363(9414):1017-24. doi: 10.1016/S0140-6736(04)15836-4.
PubMed 15051281Barber BE, William T, Grigg MJ, Yeo TW, Anstey NM. Limitations of microscopy to differentiate Plasmodium species in a region co-endemic for Plasmodium falciparum, Plasmodium vivax and Plasmodium knowlesi. Malar J. 2013 Jan 8;12:8. doi: 10.1186/1475-2875-12-8.
PubMed 23294844Komaki-Yasuda K, Vincent JP, Nakatsu M, Kato Y, Ohmagari N, Kano S. A novel PCR-based system for the detection of four species of human malaria parasites and Plasmodium knowlesi. PLoS One. 2018 Jan 25;13(1):e0191886. doi: 10.1371/journal.pone.0191886. eCollection 2018.
PubMed 29370297Lucchi NW, Poorak M, Oberstaller J, DeBarry J, Srinivasamoorthy G, Goldman I, Xayavong M, da Silva AJ, Peterson DS, Barnwell JW, Kissinger J, Udhayakumar V. A new single-step PCR assay for the detection of the zoonotic malaria parasite Plasmodium knowlesi. PLoS One. 2012;7(2):e31848. doi: 10.1371/journal.pone.0031848. Epub 2012 Feb 20.
PubMed 22363751Lucchi NW, Narayanan J, Karell MA, Xayavong M, Kariuki S, DaSilva AJ, Hill V, Udhayakumar V. Molecular diagnosis of malaria by photo-induced electron transfer fluorogenic primers: PET-PCR. PLoS One. 2013;8(2):e56677. doi: 10.1371/journal.pone.0056677. Epub 2013 Feb 20.
PubMed 23437209
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting Novel Molecular Diagnostic Methods for Detection of Plasmodium Knowlesi in Sarawak, Malaysia
- ClinicalTrials.gov ID
- NCT03988296
- Acronym / sponsor ID
- Pro00102072
- Conditions
- Plasmodium Knowlesi Infection
- Keywords
- Monkey malaria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 11 Jun 2019 (actual)
- Primary completion
- 22 Aug 2019 (actual)
- Study completion
- 22 Aug 2019 (actual)
- First posted
- 17 Jun 2019 (actual)
- 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 study aims to determine the sensitivity, specificity, and practical value of two new molecular diagnostic assays compared to a more classical nested molecular diagnostic assay and the routine microscopy (both of which are the current gold standard) in detection of P. knowlesi.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Both adults and children > 7 years old suspected for malaria and meeting inclusion criteria will be eligible to participate. Study subjects will be enrolled at Sarawak Hospitals, both hospitalized and outpatients, using an informed consent process (or assent for children 7-18 years) that permits the completion of a brief questionnaire and collection of a blood sample.
Key inclusion criteria (3 listed)
- Suspected for malaria infection; fever (axillary or tympanic temperature ≥ 37.5 °C or oral or rectal temperature of ≥ 38 °C) with chills, worsening malaise, headache lassitude, fatigue, abdominal discomfort, muscle and joint aches, anorexia, perspiration, or vomiting at the time of evaluation or within the past 48 hours
- Written informed consent is obtained.
- For Children (>7 to <18 years): parent or legal guardian provides written informed consent.
Key exclusion criteria (2 listed)
- Patients living in, or returning from malaria endemic area outside of Sarawak within 2 weeks of illness onset
- They have a clear alternative diagnosis other than malaria by a trained health care professional.
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
Number of patients with a possible diagnosis of malaria
Time frame: 10 weeks
Possible diagnosis of malaria as defined in accordance with the inclusion and exclusion criteria. Giemsa-stained thick and thin smears will be prepared for verification of parasitaemia by microscopy in the respective hospital laboratories
1 secondary outcome
Statistical association between risk factors and diagnostic assays results.
Time frame: 10 weeks
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 2 Oct 2019.
- Background: PubMed 29851611Richards J, Mueller I. Identifying the risks for human transmission of Plasmodium knowlesi. Lancet Planet Health. 2017 Jun;1(3):e83-e85. doi: 10.1016/S2542-5196(17)30053-0. Epub 2017 Jun 9. No abstract available.
- Background: PubMed 25058400Imai N, White MT, Ghani AC, Drakeley CJ. Transmission and control of Plasmodium knowlesi: a mathematical modelling study. PLoS Negl Trop Dis. 2014 Jul 24;8(7):e2978. doi: 10.1371/journal.pntd.0002978. eCollection 2014 Jul.
- Background: PubMed 23554413Singh B, Daneshvar C. Human infections and detection of Plasmodium knowlesi. Clin Microbiol Rev. 2013 Apr;26(2):165-84. doi: 10.1128/CMR.00079-12.
- Background: PubMed 15051281Singh B, Kim Sung L, Matusop A, Radhakrishnan A, Shamsul SS, Cox-Singh J, Thomas A, Conway DJ. A large focus of naturally acquired Plasmodium knowlesi infections in human beings. Lancet. 2004 Mar 27;363(9414):1017-24. doi: 10.1016/S0140-6736(04)15836-4.
- Background: PubMed 23294844Barber BE, William T, Grigg MJ, Yeo TW, Anstey NM. Limitations of microscopy to differentiate Plasmodium species in a region co-endemic for Plasmodium falciparum, Plasmodium vivax and Plasmodium knowlesi. Malar J. 2013 Jan 8;12:8. doi: 10.1186/1475-2875-12-8.
- Background: PubMed 29370297Komaki-Yasuda K, Vincent JP, Nakatsu M, Kato Y, Ohmagari N, Kano S. A novel PCR-based system for the detection of four species of human malaria parasites and Plasmodium knowlesi. PLoS One. 2018 Jan 25;13(1):e0191886. doi: 10.1371/journal.pone.0191886. eCollection 2018.
- Background: PubMed 22363751Lucchi NW, Poorak M, Oberstaller J, DeBarry J, Srinivasamoorthy G, Goldman I, Xayavong M, da Silva AJ, Peterson DS, Barnwell JW, Kissinger J, Udhayakumar V. A new single-step PCR assay for the detection of the zoonotic malaria parasite Plasmodium knowlesi. PLoS One. 2012;7(2):e31848. doi: 10.1371/journal.pone.0031848. Epub 2012 Feb 20.
- Background: PubMed 23437209Lucchi NW, Narayanan J, Karell MA, Xayavong M, Kariuki S, DaSilva AJ, Hill V, Udhayakumar V. Molecular diagnosis of malaria by photo-induced electron transfer fluorogenic primers: PET-PCR. PLoS One. 2013;8(2):e56677. doi: 10.1371/journal.pone.0056677. Epub 2013 Feb 20.
- Individual participant dataSharing planned: No. Subjects' anonymity will be maintained and confidentiality of records and documents that could identify subjects will be protected, respecting the privacy and confidentiality rules in accordance with applicable regulatory requirements. Only the site principle investigators will be able to backlink the study data to the patient's medical record.
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.
Gregory C. Gray, MD principal investigator
Duke University Medical Centre
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plasmodium Knowlesi Infection, run by Duke University at 3 sites in Malaysia.
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 3 inclusion and 2 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 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Malaysia. 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?
Number of patients with a possible diagnosis of malaria (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03988296, which also lists 8 linked publications.
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 2 Oct 2019.