Rapid Diagnostic Tests and Clinical/Laboratory Predictors of Tropical Diseases in Neurological Disorders in DRC

Summary

The impact of neurological disorders is enormous worldwide, and it is increased in poor settings, due to lack of diagnosis and treatment facilities as well as delayed management. In sub-Saharan Africa, the few observational studies conducted for the past 20 years show that neurological disorders accounted for 7 to 24% of all admissions. Central nervous system (CNS) infections were suspected in one third of all patients admitted with neurological symptoms, with a specific microbial aetiology identified in half of these. Most CNS infections may be considered as "severe and treatable diseases", e.g. human African trypanosomiasis (HAT), cerebral malaria, bacterial meningitis, CNS tuberculosis etc. If left untreated, death or serious sequels occur (mortality rates were as high as 30% in the above mentioned studies), but the outcome may be favourable with timely and appropriate management.

In poor settings, such conditions should be targeted in priority in the clinical decision-making process. Unfortunately, most neuro-infections present with non-specific symptoms in their early stages, leading to important diagnostic delays. Moreover, they require advanced diagnostic technology, which is not available in most tropical rural settings: here, you have to rely on clinical judgment and first-line laboratory results, whose confirming or excluding powers are limited or unknown. Several rapid diagnostic tests (RDTs) have been recently developed for conditions like malaria or HIV, but their diagnostic contribution has not been evaluated within a multi-disease approach.

Thus, this research aims at improving the early diagnosis of severe and treatable neglected and non-neglected infectious diseases which present with neurological symptoms in the province of Bandundu, Democratic Republic of Congo (DRC), by combining classic clinical predictors with a panel of simple point-of-care rapid diagnostic tests.

The evaluation of existing algorithms and elaboration/validation of new guidelines will be described in a subsequent protocol.

Conditions

• Neurological Disorders
• Cerebral Malaria
• Bacterial Meningitis
• Central Nervous System Tuberculosis
• Neurosyphilis
• Cryptococcal Meningitis

Interventions

DEVICE

Immunochromatographic HAT tests (DSD)

Immunochromatographic HAT diagnostic tests manufactured by DSD, Korea and FIND

DEVICE

Card Agglutination Trypanosoma Test

Card Agglutination Trypanosoma Test on whole blood and as dilution

DEVICE

TB POC Nucleic Acid Amplification Test (Molbio Diagnostics)

TB POC Nucleic Acid Amplification Test: "microPCR handheld device" (Molbio Diagnostics PVT ltd, India)

DEVICE

TB 3-marker RDT (Tulip diagnostics)

TB 3-marker RDT: ADA2/IFN-g/LAM (Tulip diagnostics, ltd, India) - pending availability for phase 3 validation

DEVICE

Cryptococcal Antigen Lateral Flow Assay (Immy)

Cryptococcal Antigen Lateral Flow Assay (Immy, USA)

Sponsors & Collaborators

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

  collaborator OTHER

• University Hospital, Geneva

  collaborator OTHER

• Institute of Tropical Medicine, Belgium

  lead OTHER

Principal Investigators

• Emmanuel Bottieau, MD · ITM

• Marleen Boelaert, MD, PhD · ITM

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

5 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-09-30

Primary Completion

2015-01-31

Completion

2015-05-31

Countries

• Democratic Republic of the Congo

Study Locations