Plasmodium Knowlesi Infection Clinical Trial
Official title:
Adapting Novel Molecular Diagnostic Methods for Detection of Plasmodium Knowlesi in Sarawak, Malaysia
| NCT number | NCT03988296 |
| Other study ID # | Pro00102072 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 11, 2019 |
| Est. completion date | August 22, 2019 |
| Verified date | June 2019 |
| Source | Duke University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 116 |
| Est. completion date | August 22, 2019 |
| Est. primary completion date | August 22, 2019 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 7 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Malaysia | Kapit Hospital | Kapit | Sarawak |
| Malaysia | Sarikei Hospital | Sarikei | Sarawak |
| Malaysia | Sibu Hospital | Sibu | Sarawak |
| Lead Sponsor | Collaborator |
|---|---|
| Duke University |
Malaysia,
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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. — View Citation
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 10 weeks | |
| Secondary | 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 | 10 weeks |