Causes of Fever in Bangladeshi Patients

NCT02339259 | Completed

• 1 other identifier: BAKMAL1408
• Study Type: observational
• Target: 416
• Locations: 1 country
• Sites: 1

Brief Summary

Background: The clinical features and prevalence of tropical rickettsial illnesses such as murine and scrub typhus in Bangladesh are unknown. Following testing for malaria, patients with undifferentiated fever are frequently treated empirically for typhoid or diagnosed clinically with a viral fever. Since murine and scrub typhus are common causes of fever in other countries in the region, it is likely they are prevalent in Bangladesh. Murine and scrub typhus may be treated cheaply and effectively with doxycycline. Primary aim: \- Describe the clinical features of scrub and murine typhus in Bangladeshi patients Secondary aims:

• Assess the proportion of patients screened for malaria having rickettsial illnesses
• Understand the pathophysiology of severe scrub typhus and murine typhus
• Prospective evaluation of rapid diagnostic tests for scrub and murine typhus Methods: Scrub typhus and murine typhus rapid tests will be introduced to CMCH in conjunction with existing malaria testing facilities. Consenting febrile adult patients who have had malaria and typhus rapid tests and meeting the entry criteria will be enrolled. Samples will be saved for serology and real time polymerase chain reaction (PCR) testing for O. tsutsugamushi and Rickettsia spp. A thorough history and examination will be undertaken. Hemodynamic status will be assessed by ultrasound upon enrolment. Patients will be followed up for outcome and a second sample will be taken for convalescent serological testing on day 14 where possible. Analysis The proportion of patients screened for malaria with an acute febrile illness due to scrub typhus and murine typhus will be calculated. The clinical features of scrub and murine typhus, malaria and patients negative for these conditions will be compared. Healthy subject samples will be used to provide normal ranges. The sensitivity and specificity of the rapid tests will be assessed as compared to the gold standard of PCR and serology combined.

Conditions

Rickettsial Disease

Keywords

Rickettsial disease; Febrile; Murine typhus; Scrub typhus; Diagnostic test; Clinical features

Outcome Measures

Primary Outcomes (1)

• The clinical features of severe and uncomplicated scrub typhus and murine typhus in Bangladeshi patients

  1 year

Secondary Outcomes (5)

• Evaluation of markers of disease severity

  1 year

• Hemodynamic status of patients with typhus

  1 year

• Diagnostic accuracy of rapid diagnostic tests for scrub and murine typhus

  1 year

• Proportion of acute rickettsial illnesses in patients screened for malaria

  1 year

• Identification of vectors harbouring Rickettsia/Orientia spp.

  1 year

Study Arms (2)

Febrile patients

Febrile patients admitted to CMCH who have had malaria film and scrub typhus and murine typhus rapid test will be screened for enrolment.

Other: Observation

Healthy

Healthy subjects with no recent history of fever will be recruited to provide control samples for the blood and plasma assays.

Other: Observation

Interventions

Observation OTHER

Febrile patients; Healthy

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The target population of this study is consenting adult patients who have had malaria and typhus rapid tests meeting the eligibility criteria admitted in CMCH. All study patients must meet the applicable inclusion and exclusion criteria. In addition, 30 healthy subjects with no recent history of fever will be recruited to provide control samples for the blood and plasma assays. The total sample size is therefore estimated to be 330 (300 patients with paired serology and 30 healthy subjects).

You may qualify if:

• Admitted to CMCH
• Have had malaria and typhus rapid tests
• Age≥12 years old
• Febrile or history of fever for \<3 weeks.
• Written informed consent from patient or attending adult (for patient who lacks capacity) or parent (for those below 18)

You may not qualify if:

• Consent refused, or no adult (≥18 years) relative or guardian present to give consent in the case the patient lacks capacity to give consent.
• No known acute or chronic medical conditions
• Asymptomatic
• No febrile illness in the last 2 weeks
• Age≥12 years old
• Written informed consent from patient or parent (for those below 18)
• \. Consent refused, or no adult (≥18 years) relative or guardian present to give consent in the case the patient is under 18 years.

Sponsors & Collaborators

• University of Oxford: lead
• Chittagong Medical College and Hospital: collaborator
• University of Amsterdam: collaborator
• Menzies School of Health Research: collaborator
• Mahidol Oxford Tropical Medicine Research Unit: collaborator

Study Sites (1)

Chittagong Medical College Hosiptal

Chittagong, Bangladesh

Location

Related Publications (20)

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  PMID: 12690274 BACKGROUND

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  PMID: 24166036 BACKGROUND

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  PMID: 20433689 BACKGROUND

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• Paris DH, Phetsouvanh R, Tanganuchitcharnchai A, Jones M, Jenjaroen K, Vongsouvath M, Ferguson DP, Blacksell SD, Newton PN, Day NP, Turner GD.

  BACKGROUND

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Biospecimen

Retention: SAMPLES WITH DNA

Blood, swab and crust specimen.

MeSH Terms

Conditions

Rickettsia Infections; Fever; Typhus, Endemic Flea-Borne; Scrub Typhus

Interventions

Observation

Condition Hierarchy (Ancestors)

Rickettsiaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vector Borne Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Amir Hossain, Professor Md

  Chittagong Medical College and Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2015
• First Posted: January 15, 2015
• Study Start: August 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: January 18, 2019

Record last verified: 2019-01

Locations

BA (1)