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

NCT03112655 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2021-02-21

No results posted yet for this study

Summary

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.

Conditions

  • African Trypanosomiasis
  • African; Trypanosomiasis, West
  • Sleeping Sickness; West African
  • Trypanosoma Brucei Gambiense; Infection

Interventions

DIAGNOSTIC_TEST

RNA and neopterin detection

Detection of spliced leader RNA will be performed on blood and cerebrospinal fluid taken before treatment, 11 days after treatment, 6, 12 and 18 months after treatment. Neopterin and 5-hydroxytryptophan will be quantified in cerebrospinal fluid taken at the same time points.

Sponsors & Collaborators

  • Institute of Tropical Medicine, Belgium

    collaborator OTHER

  • Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo

    collaborator OTHER

  • Ministry of Public Health, Democratic Republic of the Congo

    collaborator OTHER_GOV

  • Institut de Recherche pour le Developpement

    lead OTHER_GOV

Principal Investigators

  • Veerle Lejon, PhD · Institut de Recherche pour le Developpement

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-24
Primary Completion
2021-01-31
Completion
2021-01-31

Countries

  • Democratic Republic of the Congo

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03112655 on ClinicalTrials.gov