Cryptococcal Meningitis Clinical Trial
— Nidiag-NeuroOfficial 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
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.
Status | Completed |
Enrollment | 352 |
Est. completion date | May 2015 |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 5 Years and older |
Eligibility |
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) |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Congo, The Democratic Republic o | Reference Hospital Mosango | Mosango | Bandundu |
Lead Sponsor | Collaborator |
---|---|
Institute of Tropical Medicine, Belgium | Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo, University Hospital, Geneva |
Congo, The Democratic Republic of the,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevalence of HAT and other NTDs/IDs | 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) | 18 months | No |
Primary | Identification of reliable diagnostic tests | 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 | 18 months | No |
Primary | Predictive values of RDTs | Predictive values (post-test probabilities) of novel and existing RDTs, alone and in combination, for the respective target conditions within this multi-disease approach | 18 months | No |
Primary | Identification of clinical and laboratory diagnostic indicators | 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 | 18 months | No |
Secondary | Cure rate | Number of patients who positively respond to specific/empirical therapies, as assessed as final patient outcomes (cure, referral, sequelae, death) | 18 months | Yes |
Secondary | Cost-effectiveness of the diagnostic tests | Unit costs of diagnostic tests for the diagnosis of HAT and other priority NTDs/IDs in the setting | 18 months | No |
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