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Rapid Diagnostic Tests and Clinical/Laboratory Predictors of Tropical Diseases in Neurological Disorders in DRC (Nidiag-Neuro)

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ClinicalTrials.gov Identifier: NCT01589289
Recruitment Status : Completed
First Posted : May 1, 2012
Last Update Posted : January 18, 2016
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Neurological Disorders Cerebral Malaria Bacterial Meningitis Central Nervous System Tuberculosis Neurosyphilis Cryptococcal Meningitis Device: Immunochromatographic HAT tests (DSD) Device: Card Agglutination Trypanosoma Test Device: TB POC Nucleic Acid Amplification Test (Molbio Diagnostics) Device: TB 3-marker RDT (Tulip diagnostics) Device: Cryptococcal Antigen Lateral Flow Assay (Immy) Phase 3

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 352 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Rapid Diagnostic Tests in Association With Clinical and Laboratory Predictors for the Diagnosis of Neglected Tropical Diseases in Patients With Neurological Disorders in Rural Hospitals of Bandundu,Democratic Republic of Congo
Study Start Date : September 2012
Primary Completion Date : January 2015
Study Completion Date : May 2015

Arms and Interventions

Arm Intervention/treatment
Experimental: Phase 3 RDTs
The different interventions will be assessed for estimation of sensitivity, specificity and predictive values in the patients' cohort, for the respective target conditions. [To be noted that, in addition, also the predictive values of validated RDTs when used alone and in various combinations will be estimated].
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
Other Name: CATT
Device: TB POC Nucleic Acid Amplification Test (Molbio Diagnostics)
TB POC Nucleic Acid Amplification Test: "microPCR handheld device" (Molbio Diagnostics PVT ltd, India)
Other Name: NAAT
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)
Other Name: CrAg-LAT

Outcome Measures

Primary Outcome Measures :
  1. Prevalence of HAT and other NTDs/IDs [ Time Frame: 18 months ]
    Number of patients diagnosed with HAT and other NTDs/IDs among those presenting with neurological disorders in rural hospitals of Bandundu, DRC (pre-test probability)

  2. Identification of reliable diagnostic tests [ Time Frame: 18 months ]
    Assessment of the sensitivity, likelihood ratios and performances (diagnostic accuracy) of the novel study RDTs for the respective target conditions, and identification of those that should be included in future diagnostic protocols

  3. Predictive values of RDTs [ Time Frame: 18 months ]
    Predictive values (post-test probabilities) of novel and existing RDTs, alone and in combination, for the respective target conditions within this multi-disease approach

  4. Identification of clinical and laboratory diagnostic indicators [ Time Frame: 18 months ]
    Assessment of the specificity of the different clinical and first-line laboratory features for the diagnosis of HAT and other priority NTDs/IDs in the setting, for determining those that should be included in future diagnostic protocols

Secondary Outcome Measures :
  1. Cure rate [ Time Frame: 18 months ]
    Number of patients who positively respond to specific/empirical therapies, as assessed as final patient outcomes (cure, referral, sequelae, death)

  2. Cost-effectiveness of the diagnostic tests [ Time Frame: 18 months ]
    Unit costs of diagnostic tests for the diagnosis of HAT and other priority NTDs/IDs in the setting

Eligibility Criteria

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients > 5 years-old AND
  • Altered state of consciousness (confusion to coma) OR/AND
  • Changes of sleep pattern (daytime slumber, night insomnia)OR/AND
  • Cognitive decline OR/AND
  • Changes in personality/behaviour (e.g. bouts of mania)OR/AND
  • Epileptic seizure(s)OR/AND
  • Daily severe/progressive headache OR/AND
  • Meningismus (headache, neck stiffness, nausea/vomiting, photophobia)
  • Cranial nerve lesions OR/AND
  • Sensory-motor deficits or other focal neurological signs (e.g. dysphagia, dysarthria, ataxia, dystonia,...)OR/AND
  • Gait disorders (e.g. spastic or ataxic gait)

Exclusion Criteria:

  • Those unwilling or unable to give written informed consent (either directly or via proxy)
  • Those unable in the physician's opinion to comply with the study requirements
  • Neurological symptom unequivocally related with recent trauma
  • Neurological symptom as sequelae of previous well-established neurological events (e.g. stroke,…)
  • First seizure below 6 years of age (early onset seizure)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01589289

Congo, The Democratic Republic of the
Reference Hospital Mosango
Mosango, Bandundu, Congo, The Democratic Republic of the
Sponsors and Collaborators
Institute of Tropical Medicine, Belgium
Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
University Hospital, Geneva
Study Director: Emmanuel Bottieau, MD ITM
Study Chair: Marleen Boelaert, MD, PhD ITM
More Information

Responsible Party: Institute of Tropical Medicine, Belgium
ClinicalTrials.gov Identifier: NCT01589289     History of Changes
Other Study ID Numbers: WP2-01-NEU
First Posted: May 1, 2012    Key Record Dates
Last Update Posted: January 18, 2016
Last Verified: January 2016

Keywords provided by Institute of Tropical Medicine, Belgium:
Diagnostic research
Rapid diagnostic tests
Neurological disorders
Neglected Tropical Diseases
Developing countries

Additional relevant MeSH terms:
Nervous System Diseases
Meningitis, Cryptococcal
Meningitis, Bacterial
Malaria, Cerebral
Tuberculosis, Central Nervous System
Pathologic Processes
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Central Nervous System Diseases
Meningitis, Fungal
Central Nervous System Fungal Infections
Central Nervous System Infections
Central Nervous System Bacterial Infections
Central Nervous System Protozoal Infections
Central Nervous System Parasitic Infections
Parasitic Diseases
Protozoan Infections
Treponemal Infections
Gram-Negative Bacterial Infections
Spirochaetales Infections