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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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1 March 2021 |
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Main ID: |
NCT03112655 |
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Date of registration:
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31/03/2017 |
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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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Diagnostic Tools for Human African Trypanosomiasis Elimination and Clinical Trials: Early Test-of-cure
DiTECT-WP4 |
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Scientific title:
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Diagnostic Tools for Human African Trypanosomiasis Elimination and Clinical Trials: WP4 Early Test-of-cure |
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Date of first enrolment:
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February 24, 2017 |
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Target sample size:
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88 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03112655 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Sequential Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Congo, The Democratic Republic of the
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Contacts
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Name:
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Veerle Lejon, 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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Institut de Recherche pour le Developpement |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Eligible for participation in DNDi-OXA-02-HAT clinical trial
Exclusion Criteria:
- Excluded for DNDi-OXA-02-HAT clinical trial; No informed consent for participation in
the DiTECT-HAT-WP4 study
Age minimum:
15 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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African Trypanosomiasis
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African; Trypanosomiasis, West
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Sleeping Sickness; West African
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Trypanosoma Brucei Gambiense; Infection
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Intervention(s)
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Diagnostic Test: RNA and neopterin detection
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Primary Outcome(s)
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Specificity of SL-RNA detection in blood, SL-RNA detection in cerebrospinal fluid and of neopterin & 5-hydroxytryptophan quantification in cerebrospinal fluid for cure after human African trypanosomiasis treatment
[Time Frame: 18 months]
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Sensitivity of SL-RNA detection in blood, SL-RNA detection in cerebrospinal fluid and of neopterin & 5-hydroxytryptophan quantification in cerebrospinal fluid for relapse after human African trypanosomiasis treatment
[Time Frame: 18 months]
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Secondary Outcome(s)
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Sensitivity and specificity SL-RNA detection in cerebrospinal fluid for outcome assesment after treatment for human African trypanosomiasis
[Time Frame: post treatment day 11, month 6, month 12 and month 18]
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Sensitivity and specificity by ROC analysis of neopterin & 5-hydroxytryptophan quantification in cerebrospinal fluid for outcome assesment after treatment for human African trypanosomiasis
[Time Frame: post treatment day 11, month 6, month 12 and month 18]
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Sensitivity and specificity SL-RNA detection in blood for outcome assesment after treatment for human African trypanosomiasis
[Time Frame: post treatment day 11, month 6, month 12 and month 18]
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Secondary ID(s)
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DiTECT-HAT-WP4
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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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