eurological manifestations of dengue: a comparative study of viral, clinical, pathophysiological and genetic factors

Completed

• Conditions: Dengue fever (neurological); Infections and Infestations; Dengue fever [classical dengue]

• Registration Number: ISRCTN97846634
• Lead Sponsor: niversity of Oxford (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-17
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Cases:
1. Aged between 6 months and 16 years, either sex
2. Consent given by parents or legal guardians
3. History of fever with altered or reduced conscious level (Glasgow coma scale less than or equal to 14) lasting longer than 1 hour
4. History of illness of less than 7 days
5. One or more of the following on admission:
5.1. Hepatomegaly
5.2. Skin or any organ bleeding
5.3. Platelet count less than 150,000/mm^3
5.4. Haematocrit greater than 42%
5.5. Serum glutamic oxaloacetic transaminase (SGOT)/prothrombin time (PT) greater than 100
5.6. Albumin less than 3.2 g/dL
5.7. Positive rapid test for Dengue NS1 (plasma or cerebrospinal fluid [CSF]), or any of the following at Hospital for Tropical Diseases (HTD)/Oxford University Clinical Research Unit (OUCRU):
5.7.1. Positive Dengue immunoglobulin M (IgM)/NS1 enzyme-linked immunosorbent assay (ELISA) (plasma or CSF)
5.7.2. Positive dengue reverse transcription polymerase chain reaction (RT-PCR) (plasma or CSF)

Control group 1:
1. First consecutive, age-matched hospitalised dengue patient
2. Confirmed by rapid NS1-detection
3. Parents/legal guardians give informed consent to participate in the study

Control group 2:
1. First two consecutive, age-matched patients admitted with suspected viral encephalitis
2. Parents/legal guardians give informed consent to participate in the study based on:
2.1. History of fever with altered or reduced conscious level lasting longer than 1 hour
2.2. History less than 7 days
2.3. Two or more of the following signs or symptoms:
2.3.1. Seizures*
2.3.2. Agitation/delirium/behavioural changes
2.3.3. Abnormal movements
2.3.4. Facial/limb paresis/paralysis
2.3.5. Dysconjugate gaze
2.3.6. Extrapyramidal signs/symptoms (e.g. ataxia, tremor, rigidity, masked facies)
2.3.7. Neck stiffness
2.3.8. Tense fontanel
2.3.9. CSF pleiocytosis
2.3.10. Electroencephalogram (EEG)/neuroimaging findings consistent with encephalitis, or
2.4. Laboratory evidence of viral aetiology of encephalitis

*Children between six months and five years with a single convulsion lasting less than 15 minutes who recovered consciousness within 60 minutes are considered to have had a simple febrile convulsion

Exclusion Criteria

1. Bacterial, mycobacterial or parasitological causes as evidenced by microscopy or culture of CSF
2. Pre-existing neurological conditions, e.g. cerebral palsy, epilepsy, cerebral infarction/haemorrhage
3. Pre-existing chronic liver or renal disease

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. To compare the clinical, radiological and laboratory findings in paediatric dengue patients with and without neurological manifestations and in children with Japanese encephalitis or other viral encephalitides and relate this to outcome