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NCT03112655: DiTECT-WP4

Diagnostic Tools for Human African Trypanosomiasis Elimination and Clinical Trials: Early Test-of-cure

Completed NA Last updated 21 February 2021
What this trial tests

NA trial testing RNA and neopterin detection in African Trypanosomiasis in 88 participants. Completed in 31 January 2021.

Timeline
24 February 2017
Primary endpoint
31 January 2021
31 January 2021

Quick facts

Lead sponsorInstitut de Recherche pour le Developpement
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsequential
Maskingnone
Primary purposediagnostic
Enrollment88
Start date24 February 2017
Primary completion31 January 2021
Estimated completion31 January 2021
Sites1 location across Democratic Republic of the Congo

Drugs / interventions tested

Conditions studied

Sponsor

Institut de Recherche pour le Developpement — full company profile →

Who can join

15 and older, any sex, with African Trypanosomiasis or African; Trypanosomiasis, West. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study validates the diagnostic performance of cerebrospinal fluid neopterin quantification and of blood and cerebrospinal fluid trypanosomal spliced leader RNA detection for assessing outcome after treatment of human African trypanosomiasis.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Trypanosome SL-RNA detection in blood and cerebrospinal fluid to demonstrate active gambiense human African trypanosomiasis infection.
    Ngay Lukusa I, Van Reet N, Mumba Ngoyi D, Miaka EM, et al · · 2021 · cited 9× · PMID 34534223 · DOI 10.1371/journal.pntd.0009739
  2. Trypanosome spliced leader RNA for diagnosis of acoziborole treatment outcome in gambiense human African trypanosomiasis: A longitudinal follow-up study.
    Ngay Lukusa I, Van Reet N, Mumba Ngoyi D, Mwamba Miaka E, et al · · 2022 · cited 4× · PMID 36436279 · DOI 10.1016/j.ebiom.2022.104376

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