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出境医 / 临床实验 / Molecular Diagnostic Methods for Detection of Plasmodium Knowlesi

Molecular Diagnostic Methods for Detection of Plasmodium Knowlesi

Study Description
Brief 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.

Condition or disease
Plasmodium Knowlesi Infection

Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 116 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Adapting Novel Molecular Diagnostic Methods for Detection of Plasmodium Knowlesi in Sarawak, Malaysia
Actual Study Start Date : June 11, 2019
Actual Primary Completion Date : August 22, 2019
Actual Study Completion Date : August 22, 2019
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Statistical association between risk factors and diagnostic assays results. [ Time Frame: 10 weeks ]
    A brief enrollment questionnaire will be used to determine a statistical association between demographic and behavioral/occupational risk factors and the assays results combined


Biospecimen Retention:   Samples With DNA
5ml Whole blood samples will be collected in a labeled EDTA acid tube. A minimum of 250ul of whole blood will be used to prepare dried blood spots on filter cards at the time of patient enrollment in the respective hospital. Extracted DNA from the remaining whole blood sample will be used to conduct molecular assays at Clinical Research Centre Sibu Hospital. Extracted DNA will be tested with the new single-step polymerase chain reaction (PCR) and the nested PCR at Sibu Hospital. An aliquot of same DNA will be shipped on dry ice to the CDC (Georgia, USA) for performing photo-induced electron transfer - polymerase chain reaction (PET-PCR) assays

Eligibility Criteria
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Ages Eligible for Study:   7 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations

Locations
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Malaysia
Kapit Hospital
Kapit, Sarawak, Malaysia, 96800
Sarikei Hospital
Sarikei, Sarawak, Malaysia, 96100
Sibu Hospital
Sibu, Sarawak, Malaysia, 96000
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Gregory C. Gray, MD Duke University Medical Centre
Tracking Information
First Submitted Date June 13, 2019
First Posted Date June 17, 2019
Last Update Posted Date October 2, 2019
Actual Study Start Date June 11, 2019
Actual Primary Completion Date August 22, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 13, 2019) 		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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 13, 2019) 		Statistical association between risk factors and diagnostic assays results. [ Time Frame: 10 weeks ]
A brief enrollment questionnaire will be used to determine a statistical association between demographic and behavioral/occupational risk factors and the assays results combined
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Molecular Diagnostic Methods for Detection of Plasmodium Knowlesi
Official Title Adapting Novel Molecular Diagnostic Methods for Detection of Plasmodium Knowlesi in Sarawak, Malaysia
Brief 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
5ml Whole blood samples will be collected in a labeled EDTA acid tube. A minimum of 250ul of whole blood will be used to prepare dried blood spots on filter cards at the time of patient enrollment in the respective hospital. Extracted DNA from the remaining whole blood sample will be used to conduct molecular assays at Clinical Research Centre Sibu Hospital. Extracted DNA will be tested with the new single-step polymerase chain reaction (PCR) and the nested PCR at Sibu Hospital. An aliquot of same DNA will be shipped on dry ice to the CDC (Georgia, USA) for performing photo-induced electron transfer - polymerase chain reaction (PET-PCR) assays
Sampling Method Non-Probability Sample
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.
Condition Plasmodium Knowlesi Infection
Intervention Not Provided
Study Groups/Cohorts Not Provided
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.
  • Imai 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.
  • Singh 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. Review.
  • Singh 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.
  • Barber 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.
  • Komaki-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.
  • Lucchi 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.
  • Lucchi 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 30, 2019) 		116
Original Estimated Enrollment
 (submitted: June 13, 2019) 		120
Actual Study Completion Date August 22, 2019
Actual Primary Completion Date August 22, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 7 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Malaysia
Removed Location Countries  
 
Administrative Information
NCT Number NCT03988296
Other Study ID Numbers Pro00102072
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: 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.
Responsible Party Duke University
Study Sponsor Duke University
Collaborators Not Provided
Investigators
Principal Investigator: Gregory C. Gray, MD Duke University Medical Centre
PRS Account Duke University
Verification Date June 2019

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