CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 416 enrolled
Drug / intervention
Observationother
Likely dose
Not stated in record
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Search/NCT02339259
NCT02339259N/ACompleted

Rickettsial Disease in Febrile Hospitalised Patients in a Tertiary Referral Hospital in Bangladesh

University of Oxford·observational·Posted Jan 15, 2015·Updated Jan 18, 2019

In Brief

An observational study evaluating Observation for Rickettsial Disease. Completed, enrolled 416 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesBangladesh

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 15, 2015
Enrollment StartAug 1, 2014
Primary CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 11.5 years ago

Interventions

Observationother