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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03528265 |
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Date of registration:
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07/05/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Adapting LFI for Melioidosis
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Scientific title:
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Adapting a Rapid Lateral Flow Burkholderia Pseudomallei Immunoassay in Sarawak, Malaysia |
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Date of first enrolment:
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June 21, 2018 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03528265 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Malaysia
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Contacts
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Name:
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Gregory C Gray, MD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Duke University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Admitted to Kapit Hospital
- Fever more than 3 days and one or more of the following:
- Enlarged cervical, inguinal or axillary lymph nodes (greater than 3 cm in
diameter), painless adenopathy or lymphadenitis or lymph node abscesses
- One or both sides glands involvement such as tender swelling over medial aspect
of the lower eyelid of the lacrimal glands; submandibular glands, parotic glands
- Bedside scan with splenic or liver hypoechoic lesion (less than 2cm in diameter)
- Pneumonia not responding to 48 hours of first line antibiotics
- One or more joint pain with swelling
- Purplish vesicle or bullae mainly over the lower limbs, may resulting in ulcer
after rupture
- Deep seated abscess or brain abscess or genitourinary abscess or osteomyelitis
- Severe sepsis patient with or without shock and/or with multiorgan involvement
Exclusion Criteria:
- Have a clear alternative diagnosis other than melioidosis by a trained health care
professional at the Kapit Hospital
- Have already been treated for melioidosis (e.g. received antibiotics before the start
of the study)
- Are younger than 6 months of age
Age minimum:
6 Months
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Melioidosis
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Intervention(s)
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Device: Lateral flow immunoassay
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Primary Outcome(s)
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Proportion of true negative
[Time Frame: up to 5 weeks]
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Proportion of true positive
[Time Frame: up to 5 weeks]
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Secondary Outcome(s)
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Statistical association between risk factors and test results
[Time Frame: up to 3 months]
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Secondary ID(s)
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Pro00091842
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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