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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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7 November 2016 |
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Main ID: |
NCT01766830 |
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Date of registration:
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09/01/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Rapid Diagnostic Tests and Clinical/Laboratory Predictors of Tropical Diseases In Patients With Persistent Fever in Cambodia, Nepal, Democratic Republic of the Congo and Sudan (NIDIAG-Fever)
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Scientific title:
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Evaluation of Rapid Diagnostic Tests (RDT) in Association With Clinical and Laboratory Predictors for the Diagnosis of Neglected Tropical Diseases (NTD) in Patients Presenting With Persistent Fever (=1 Week) in Cambodia, Nepal, Democratic Republic of the Congo and Sudan |
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Date of first enrolment:
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January 2013 |
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Target sample size:
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1927 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01766830 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Phase:
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N/A
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Countries of recruitment
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Cambodia
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Congo, The Democratic Republic of the
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Nepal
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Sudan
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Contacts
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Name:
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François Chappuis, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospitals, Geneva |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- fever for = 1 week
- = 5 years old (18 years onward in Cambodia)
Exclusion Criteria:
- unwilling or unable to give written informed consent
- unable in the study physician's opinion to comply with the study requirements
- existing laboratory confirmed diagnosis
- need of immediate intensive care due to shock or respiratory distress
Age minimum:
5 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Human African Trypanosomiasis
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HIV
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Enteric Fever
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Melioidosis
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Rickettsial Diseases
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Tuberculosis
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Amoebic Liver Abscess
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Brucellosis
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Leptospirosis
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Relapsing Fever
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Malaria
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Visceral Leishmaniasis
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Intervention(s)
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Device: Test-it Typhoid IgM
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Device: Card Agglutination Trypanosoma Test (CATT)-10
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Device: IT LEISH (rK39)
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Device: Leptospira IgG/IgM
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Device: HAT Serostrip
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Device: rk28 ICT
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Device: Immunochromatographic HAT test
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Device: Typhidot M
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Device: S. typhi IgM/IgG
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Device: Test-it Leptospirosis IgM
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Primary Outcome(s)
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Identification of reliable Rapid Diagnostic Tests (RDTs)
[Time Frame: 18 months]
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Predictive values of RDTs
[Time Frame: 18 months]
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Prevalence of Visceral Leishmaniasis (VL), Human African Trypanosomiasis (HAT) and other Neglected Tropical Diseases (NTDs)
[Time Frame: 18 months]
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Identification of clinical and laboratory diagnostic indicators
[Time Frame: 18 months]
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Secondary Outcome(s)
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Cost-effectiveness of the diagnostic tests
[Time Frame: 18 months]
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Secondary ID(s)
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260260
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WP2-01-FEV
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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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