Malaria DiagnosisNCT03511443
Evaluation of the Performance of a hsRDT Versus cRDT in Reactive Case Detection of Malaria Infections
A study testing hsRDT in people with Malaria Diagnosis and Malaria,Falciparum, run by University Research Co, LLC at 1 site in Burma.
Trial summary
A systematic review assessing the role, appropriateness and benefits of the active case detection strategy, both proactive and reactive, in low malaria transmission settings. A common indication is that more studies should be carried out to optimize the ACD strategy to the local context, or to provide evidence for the… Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malaria Diagnosis, Malaria,Falciparum
- What is being tested?
- hsRDT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,980 participants
- Where
- 1 siteBurma
- Study dates
- 2 Oct 2017to 1 Oct 2018
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age at least 5 years old
- Resident of the villages, or temporary visitors, or co-workers or co-travelers of index case
- Willingness to participate in the study evident by informed consent
Who cannot join
- Presence of severe clinical illness including severe malaria
- Non-resident index cases
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
Burma1 site, 1 recruiting
- Recruiting
University Research Co., LLC (URC)
Yangon
Kyaw Myint Tun, 9595039861, ktun@urc-chs.com
About this study
Official title: Evaluation of the Performance of a Highly-sensitive Rapid Diagnostic Test (RDT) Versus Conventional RDT, Compared With PCR as the Gold Standard, in Reactive Case Detection of Malaria Infections in Rakhine State, Myanmar
A systematic review assessing the role, appropriateness and benefits of the active case detection strategy, both proactive and reactive, in low malaria transmission settings. A common indication is that more studies should be carried out to optimize the ACD strategy to the local context, or to provide evidence for the adoption of improved methods. One possible improved method is the use of more accurate diagnostic tools, such as the hsRDT proposed in this study, with an increased capacity to detect lower levels of parasitemia. It can provide a timely and relevant contribution for their development of national Standard Operating Procedures for a screening tool in the reactive case detection strategy.
Read the detailed description
The study is conducted in the areas under Sakhanmaw Rural Health Center, Ann Township in Southern Rakhine State, Myanmar.
General objective was to evaluate the performance of the new highly-sensitive rapid diagnostic test (RDT) developed by SD Bioline versus conventional RDT, compared with PCR as the gold standard, in reactive case detection of malaria infections in Rakhine State, Myanmar.
Specific objectives
- To evaluate the prevalence of malaria identified by the new hsRDT in comparison with that by cRDT and PCR
- To assess the diagnostic performance characteristics of hsRDT versus cRDT, using PCR as gold standard, in the detection of P.falciparum infections
- To evaluate correlation of detection capability between cRDT and hsRDT
- To identify risk factors associated with malaria infection, including but not limited to, socio-demographic factors and travel history related with malaria index cases
This is a prospective community-based single-center reactive case detection (RCD) study to assess the performance of hsRDT versus cRDT in identifying individuals with malaria infection ("Secondary case") in a population living and/or working in a close physical proximity to an "index case." All cases parasitologically confirmed by conventional RDT will be promptly notified to the study team and interviewed with a standardized case investigation form at their home, possibly within 3 days. All members of the primary case household and those of the nearest 10 households, aged 5 years and above, will be invited to participate in the study. A blood spot will be collected for subsequent PCR analysis. At least 50 index cases are targeted for investigation and reactive case detection and an estimated number of 1,980 persons will be involved in the study.
It is expected that this study will be an important input for the national malaria control program in Myanmar as they develop the strategies to conduct reactive case detection.
A suitable statistical software, e.g. STATA will be used to analyze the data resulting from the participant interviews and 3 parasitological tests. Logistic regression models will be developed to examine factors significantly associated with malaria infections.
- Conditions
- Malaria Diagnosis, Malaria,Falciparum
- Being tested
- hsRDT
- Keywords
- hsRDT, usRDT, Reactive Case Detection (RCD), High risk for malaria
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hsRDTDiagnostic test
Also called Highly sensitive RDT is also used as ultrasensitive RDT
Testing highly sensitive RDT detection for low parasitemia
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic performance of hsRDT | Other | Comparing diagnostic power of two diagnostics Receives: Diagnostic Test: hsRDT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of malaria infections identified by the new hsRDT
Outcomes measured by malaria test positivity rate by cRDT, hsRDT and PCR, respectively
Measured: PCR diagnosis of samples will occur after 10 months of data collection.
Secondary outcomes (3)
Diagnostic performance characteristics of hsRDT versus cRDT using PCR as gold standard, in the detection of P.falciparum infections
Outcomes measured between hsRDT and cRDT
Measured: Outcomes will be analyzed after 10 months of data collection
Correlation of detection capability between cRDT and hsRDT
Outcomes measured by correlation of test positivity rates
Measured: PCR results will be analyzed during month 10
Risk factors associated with malaria infection cases
Outcomes will be measured by relative risk of malaria in association with different risk factors identified
Measured: Outcome will be measured/analyzed in month 10, after PCR results are released
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start2 Oct 2017
- Primary completion28 Jun 2018 (estimated)
- Study completion1 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- If P.f malaria case were detected, the responsible malaria worker or basic health staff will inform to survey team and blood samples for cRDT, hsRDT, Dried Blood Spot for PCR will be collected from index case and contacts (nearby 10-household members and peers). Then the results of cRDT and hsRDT will be confirmed by PCR for evaluating their performance. Then the applicability of hsRDT to detect low parasitaemia for enhancing malaria elimination activities will be evaluated.
- Masking
- None (open label)
- Enrolment
- 1,980 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Research Co, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Duke University, United States Agency for International Development (USAID), Department of Medical Research, Lower Myanmar, Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Saw Lwin, MD, Study chair, University Research Co, LLCFeliciano Monti, MD, Study chair, US Embassy, Yangon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03511443
- Sponsor's protocol ID
- HP-00076579
- Other IDs
- Pro00089928
- Status last verified
- Apr 2018
- First submitted
- 19 Mar 2018
- Last updated
- 27 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chen I, Clarke SE, Gosling R, Hamainza B, Killeen G, Magill A, O'Meara W, Price RN, Riley EM. "Asymptomatic" Malaria: A Chronic and Debilitating Infection That Should Be Treated. PLoS Med. 2016 Jan 19;13(1):e1001942. doi: 10.1371/journal.pmed.1001942. eCollection 2016 Jan.
PubMed 26783752malERA Consultative Group on Health Systems and Operational Research. A research agenda for malaria eradication: health systems and operational research. PLoS Med. 2011 Jan 25;8(1):e1000397. doi: 10.1371/journal.pmed.1000397.
PubMed 21311588Adams M, Joshi SN, Mbambo G, Mu AZ, Roemmich SM, Shrestha B, Strauss KA, Johnson NE, Oo KZ, Hlaing TM, Han ZY, Han KT, Thura S, Richards AK, Huang F, Nyunt MM, Plowe CV. An ultrasensitive reverse transcription polymerase chain reaction assay to detect asymptomatic low-density Plasmodium falciparum and Plasmodium vivax infections in small volume blood samples. Malar J. 2015 Dec 23;14:520. doi: 10.1186/s12936-015-1038-z.
PubMed 26701778Cheng Z, Wang D, Tian X, Sun Y, Sun X, Xiao N, Zheng Z. Capture and Ligation Probe-PCR (CLIP-PCR) for Molecular Screening, with Application to Active Malaria Surveillance for Elimination. Clin Chem. 2015 Jun;61(6):821-8. doi: 10.1373/clinchem.2014.237115. Epub 2015 May 11.
PubMed 25964304Okell LC, Ghani AC, Lyons E, Drakeley CJ. Submicroscopic infection in Plasmodium falciparum-endemic populations: a systematic review and meta-analysis. J Infect Dis. 2009 Nov 15;200(10):1509-17. doi: 10.1086/644781.
PubMed 19848588Imwong M, Hanchana S, Malleret B, Renia L, Day NP, Dondorp A, Nosten F, Snounou G, White NJ. High-throughput ultrasensitive molecular techniques for quantifying low-density malaria parasitemias. J Clin Microbiol. 2014 Sep;52(9):3303-9. doi: 10.1128/JCM.01057-14. Epub 2014 Jul 2.
PubMed 24989601Imwong M, Nguyen TN, Tripura R, Peto TJ, Lee SJ, Lwin KM, Suangkanarat P, Jeeyapant A, Vihokhern B, Wongsaen K, Van Hue D, Dong le T, Nguyen TU, Lubell Y, von Seidlein L, Dhorda M, Promnarate C, Snounou G, Malleret B, Renia L, Keereecharoen L, Singhasivanon P, Sirithiranont P, Chalk J, Nguon C, Hien TT, Day N, White NJ, Dondorp A, Nosten F. The epidemiology of subclinical malaria infections in South-East Asia: findings from cross-sectional surveys in Thailand-Myanmar border areas, Cambodia, and Vietnam. Malar J. 2015 Sep 30;14:381. doi: 10.1186/s12936-015-0906-x.
PubMed 26424000Searle KM, Shields T, Hamapumbu H, Kobayashi T, Mharakurwa S, Thuma PE, Smith DL, Glass G, Moss WJ. Efficiency of household reactive case detection for malaria in rural Southern Zambia: simulations based on cross-sectional surveys from two epidemiological settings. PLoS One. 2013 Aug 6;8(8):e70972. doi: 10.1371/journal.pone.0070972. Print 2013.
PubMed 23940677van Eijk AM, Ramanathapuram L, Sutton PL, Kanagaraj D, Sri Lakshmi Priya G, Ravishankaran S, Asokan A, Tandel N, Patel A, Desai N, Singh R, Sullivan SA, Carlton JM, Srivastava HC, Eapen A. What is the value of reactive case detection in malaria control? A case-study in India and a systematic review. Malar J. 2016 Feb 6;15:67. doi: 10.1186/s12936-016-1120-1.
PubMed 26852118Hustedt J, Canavati SE, Rang C, Ashton RA, Khim N, Berne L, Kim S, Sovannaroth S, Ly P, Menard D, Cox J, Meek S, Roca-Feltrer A. Reactive case-detection of malaria in Pailin Province, Western Cambodia: lessons from a year-long evaluation in a pre-elimination setting. Malar J. 2016 Mar 1;15:132. doi: 10.1186/s12936-016-1191-z.
PubMed 26931488
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Performance of a Highly-sensitive Rapid Diagnostic Test (RDT) Versus Conventional RDT, Compared With PCR as the Gold Standard, in Reactive Case Detection of Malaria Infections in Rakhine State, Myanmar
- ClinicalTrials.gov ID
- NCT03511443
- Acronym / sponsor ID
- HP-00076579
- Conditions
- Malaria Diagnosis, Malaria,Falciparum
- Keywords
- hsRDT, usRDT, Reactive Case Detection (RCD), High risk for malaria
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,980 participants (estimated)
- Lead sponsor
- University Research Co, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Duke University, United States Agency for International Development (USAID), Department of Medical Research, Lower Myanmar, Centers for Disease Control and Prevention
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 28 Jun 2018 (estimated)
- Study completion
- 1 Oct 2018 (estimated)
- First posted
- 27 Apr 2018 (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.
A systematic review assessing the role, appropriateness and benefits of the active case detection strategy, both proactive and reactive, in low malaria transmission settings. A common indication is that more studies should be carried out to optimize the ACD strategy to the local context, or to provide evidence for the adoption of improved methods. One possible improved method is the use of more accurate diagnostic tools, such as the hsRDT proposed in this study, with an increased capacity to detect lower levels of parasitemia. It can provide a timely and relevant contribution for their development of national Standard Operating Procedures for a screening tool in the reactive case detection strategy.
Detailed description
The study is conducted in the areas under Sakhanmaw Rural Health Center, Ann Township in Southern Rakhine State, Myanmar.
General objective was to evaluate the performance of the new highly-sensitive rapid diagnostic test (RDT) developed by SD Bioline versus conventional RDT, compared with PCR as the gold standard, in reactive case detection of malaria infections in Rakhine State, Myanmar.
Specific objectives
- To evaluate the prevalence of malaria identified by the new hsRDT in comparison with that by cRDT and PCR
- To assess the diagnostic performance characteristics of hsRDT versus cRDT, using PCR as gold standard, in the detection of P.falciparum infections
- To evaluate correlation of detection capability between cRDT and hsRDT
- To identify risk factors associated with malaria infection, including but not limited to, socio-demographic factors and travel history related with malaria index cases
This is a prospective community-based single-center reactive case detection (RCD) study to assess the performance of hsRDT versus cRDT in identifying individuals with malaria infection ("Secondary case") in a population living and/or working in a close physical proximity to an "index case." All cases parasitologically confirmed by conventional RDT will be promptly notified to the study team and interviewed with a standardized case investigation form at their home, possibly within 3 days. All members of the primary case household and those of the nearest 10 households, aged 5 years and above, will be invited to participate in the study. A blood spot will be collected for subsequent PCR analysis. At least 50 index cases are targeted for investigation and reactive case detection and an estimated number of 1,980 persons will be involved in the study.
It is expected that this study will be an important input for the national malaria control program in Myanmar as they develop the strategies to conduct reactive case detection.
A suitable statistical software, e.g. STATA will be used to analyze the data resulting from the participant interviews and 3 parasitological tests. Logistic regression models will be developed to examine factors significantly associated with malaria infections.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- If P.f malaria case were detected, the responsible malaria worker or basic health staff will inform to survey team and blood samples for cRDT, hsRDT, Dried Blood Spot for PCR will be collected from index case and contacts (nearby 10-household members and peers). Then the results of cRDT and hsRDT will be confirmed by PCR for evaluating their performance. Then the applicability of hsRDT to detect low parasitaemia for enhancing malaria elimination activities will be evaluated.
| Arm | Type | Receives |
|---|---|---|
| Diagnostic performance of hsRDT | Other | Diagnostic Test: hsRDTComparing diagnostic power of two diagnostics |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age at least 5 years old
- Resident of the villages, or temporary visitors, or co-workers or co-travelers of index case
- Willingness to participate in the study evident by informed consent
Key exclusion criteria (3 listed)
- Presence of severe clinical illness including severe malaria
- Non-resident index cases
- Refusal 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hsRDTAlso: Highly sensitive RDT is also used as ultrasensitive RDTTesting highly sensitive RDT detection for low parasitemia | Diagnostic test | Diagnostic performance of hsRDT |
Primary outcome
Prevalence of malaria infections identified by the new hsRDT
Time frame: PCR diagnosis of samples will occur after 10 months of data collection.
Outcomes measured by malaria test positivity rate by cRDT, hsRDT and PCR, respectively
3 secondary outcomes
Diagnostic performance characteristics of hsRDT versus cRDT using PCR as gold standard, in the detection of P.falciparum infections
Time frame: Outcomes will be analyzed after 10 months of data collection
Correlation of detection capability between cRDT and hsRDT
Time frame: PCR results will be analyzed during month 10
Risk factors associated with malaria infection cases
Time frame: Outcome will be measured/analyzed in month 10, after PCR results are released
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2018.
- Background: PubMed 26783752Chen I, Clarke SE, Gosling R, Hamainza B, Killeen G, Magill A, O'Meara W, Price RN, Riley EM. "Asymptomatic" Malaria: A Chronic and Debilitating Infection That Should Be Treated. PLoS Med. 2016 Jan 19;13(1):e1001942. doi: 10.1371/journal.pmed.1001942. eCollection 2016 Jan.
- Background: PubMed 21311588malERA Consultative Group on Health Systems and Operational Research. A research agenda for malaria eradication: health systems and operational research. PLoS Med. 2011 Jan 25;8(1):e1000397. doi: 10.1371/journal.pmed.1000397.
- Background: PubMed 26701778Adams M, Joshi SN, Mbambo G, Mu AZ, Roemmich SM, Shrestha B, Strauss KA, Johnson NE, Oo KZ, Hlaing TM, Han ZY, Han KT, Thura S, Richards AK, Huang F, Nyunt MM, Plowe CV. An ultrasensitive reverse transcription polymerase chain reaction assay to detect asymptomatic low-density Plasmodium falciparum and Plasmodium vivax infections in small volume blood samples. Malar J. 2015 Dec 23;14:520. doi: 10.1186/s12936-015-1038-z.
- Background: PubMed 25964304Cheng Z, Wang D, Tian X, Sun Y, Sun X, Xiao N, Zheng Z. Capture and Ligation Probe-PCR (CLIP-PCR) for Molecular Screening, with Application to Active Malaria Surveillance for Elimination. Clin Chem. 2015 Jun;61(6):821-8. doi: 10.1373/clinchem.2014.237115. Epub 2015 May 11.
- Background: PubMed 19848588Okell LC, Ghani AC, Lyons E, Drakeley CJ. Submicroscopic infection in Plasmodium falciparum-endemic populations: a systematic review and meta-analysis. J Infect Dis. 2009 Nov 15;200(10):1509-17. doi: 10.1086/644781.
- Background: PubMed 24989601Imwong M, Hanchana S, Malleret B, Renia L, Day NP, Dondorp A, Nosten F, Snounou G, White NJ. High-throughput ultrasensitive molecular techniques for quantifying low-density malaria parasitemias. J Clin Microbiol. 2014 Sep;52(9):3303-9. doi: 10.1128/JCM.01057-14. Epub 2014 Jul 2.
- Background: PubMed 26424000Imwong M, Nguyen TN, Tripura R, Peto TJ, Lee SJ, Lwin KM, Suangkanarat P, Jeeyapant A, Vihokhern B, Wongsaen K, Van Hue D, Dong le T, Nguyen TU, Lubell Y, von Seidlein L, Dhorda M, Promnarate C, Snounou G, Malleret B, Renia L, Keereecharoen L, Singhasivanon P, Sirithiranont P, Chalk J, Nguon C, Hien TT, Day N, White NJ, Dondorp A, Nosten F. The epidemiology of subclinical malaria infections in South-East Asia: findings from cross-sectional surveys in Thailand-Myanmar border areas, Cambodia, and Vietnam. Malar J. 2015 Sep 30;14:381. doi: 10.1186/s12936-015-0906-x.
- Background: PubMed 23940677Searle KM, Shields T, Hamapumbu H, Kobayashi T, Mharakurwa S, Thuma PE, Smith DL, Glass G, Moss WJ. Efficiency of household reactive case detection for malaria in rural Southern Zambia: simulations based on cross-sectional surveys from two epidemiological settings. PLoS One. 2013 Aug 6;8(8):e70972. doi: 10.1371/journal.pone.0070972. Print 2013.
- Background: PubMed 26852118van Eijk AM, Ramanathapuram L, Sutton PL, Kanagaraj D, Sri Lakshmi Priya G, Ravishankaran S, Asokan A, Tandel N, Patel A, Desai N, Singh R, Sullivan SA, Carlton JM, Srivastava HC, Eapen A. What is the value of reactive case detection in malaria control? A case-study in India and a systematic review. Malar J. 2016 Feb 6;15:67. doi: 10.1186/s12936-016-1120-1.
- Background: PubMed 26931488Hustedt J, Canavati SE, Rang C, Ashton RA, Khim N, Berne L, Kim S, Sovannaroth S, Ly P, Menard D, Cox J, Meek S, Roca-Feltrer A. Reactive case-detection of malaria in Pailin Province, Western Cambodia: lessons from a year-long evaluation in a pre-elimination setting. Malar J. 2016 Mar 1;15:132. doi: 10.1186/s12936-016-1191-z.
- Individual participant dataSharing planned: Undecided
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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.
Saw Lwin, MD study chair
University Research Co, LLC
Feliciano Monti, MD study chair
US Embassy, Yangon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hsRDT in people with Malaria Diagnosis and Malaria,Falciparum, run by University Research Co, LLC at 1 site in Burma.
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 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: status not confirmed, as of the sponsor's last update on 27 Apr 2018. 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 Burma. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact San Kyawt Khine, MD (959450542076, skkhine.khine75@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of malaria infections identified by the new hsRDT (time frame: PCR diagnosis of samples will occur after 10 months of data collection.). 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 NCT03511443, which also lists 10 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 27 Apr 2018.