Rickettsial DiseaseNCT02339259
Causes of Fever in Bangladeshi Patients
An observational study of Rickettsial Disease, run by University of Oxford at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rickettsial Disease
- What is being tested?
- Observation
- How many people
- 416 participants
- Where
- 1 siteBangladesh
- Study dates
- Aug 2014to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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).
Who may be able to join
- 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)
Who cannot join
- Consent refused, or no adult (≥18 years) relative or guardian present to give consent in the case the patient lacks capacity to give consent.
- Healthy subjects Inclusion
- 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)
- 1. Consent refused, or no adult (≥18 years) relative or guardian present to give consent in the case the patient is under 18 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rickettsial Disease in Febrile Hospitalised Patients in a Tertiary Referral Hospital in Bangladesh
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.
Read more
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.
Read the detailed description
Proposed activities:
The primary objective of this study are to assess the clinical features of patients with scrub or murine typhus infections presenting to CMCH. The proportion of cases screened for malaria and typhus who are diagnosed with scrub and murine typhus during the study period will be calculated, and the data made available for future empiric treatment guideline preparation.
Rapid antibody-based tests for scrub typhus and murine typhus will be made available for physicians to request alongside malaria testing in CMCH. Consenting febrile patients admitted to CMCH will be enrolled and history and clinical examination recorded. A sample will be taken for reference diagnostic testing at a later stage (including indirect fluorescent antibody (IFA) and real time PCR for scrub typhus and Rickettsia spp.)16. Samples will also be taken for testing of markers of pathophysiology (endothelial dysfunction neutrophil activation, cell death, cytokines). Where an eschar is found, the scab will be removed for real time-PCR. Where possible, patients will be invited back for a follow up 14 days after enrolment and a sample collected for paired serology assayed by IFA testing. Ultrasound based hemodynamic assessment will be performed to assess volume status and evidence of cardiac dysfunction.
The results of the ultrasound based hemodynamic assessment will be used to provide baseline information on patients with O. tsutsugamushi and Rickettsia spp. infection and other infections. This information may be used to plan further studies on the fluid management of these conditions.
Study design:
This is an observational study with no intervention. Febrile patients admitted to CMCH who have had malaria film and scrub typhus and murine typhus rapid test will be screened for enrolment. If patients meet the entry criteria, they will be enrolled after written informed consent has been given. Enrolled patients will then undergo study procedures (blood tests, physical examinations, follow-up).
Overall Description of study Participants:
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.
During the study period, we aim to prospectively recruit consecutive patients until 300 patients are enrolled for whom there are paired admission and convalescent samples.
Data obtained from the malaria patients and patients without malaria or typhus will be used as comparator groups for the patients with typhus. The data from the 300 consecutive patients will be used to prospectively assess the sensitivity and specificity of the typhus diagnostic tests.
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 with paired serology and 30 healthy subjects).
- Conditions
- Rickettsial Disease
- Being tested
- Observation
- Keywords
- Rickettsial disease, Febrile, Murine typhus, Scrub typhus, Diagnostic test, Clinical features
- Medical subject headings
- Rickettsia Infections, Fever, Typhus, Endemic Flea-Borne, Scrub Typhus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Observation | |
| Healthy | Healthy subjects with no recent history of fever will be recruited to provide control samples for the blood and plasma assays. Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The clinical features of severe and uncomplicated scrub typhus and murine typhus in Bangladeshi patients
Measured: 1 year
Secondary outcomes (5)
Evaluation of markers of disease severity
Measured: 1 year
Hemodynamic status of patients with typhus
Measured: 1 year
Diagnostic accuracy of rapid diagnostic tests for scrub and murine typhus
Measured: 1 year
Proportion of acute rickettsial illnesses in patients screened for malaria
Measured: 1 year
Identification of vectors harbouring Rickettsia/Orientia spp.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2015 (estimated)
- Study startAug 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Rickettsial DiseaseStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 416 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Chittagong Medical College and Hospital, University of Amsterdam, Menzies School of Health Research, Mahidol Oxford Tropical Medicine Research Unit
- Responsible party
- Sponsor
- Investigators
- Amir Hossain, Professor Md, Principal investigator, Chittagong Medical College and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02339259
- Sponsor's protocol ID
- BAKMAL1408
- Status last verified
- Jan 2019
- First submitted
- 8 Jan 2015
- Last updated
- 18 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Suttinont C, Losuwanaluk K, Niwatayakul K, Hoontrakul S, Intaranongpai W, Silpasakorn S, Suwancharoen D, Panlar P, Saisongkorh W, Rolain JM, Raoult D, Suputtamongkol Y. Causes of acute, undifferentiated, febrile illness in rural Thailand: results of a prospective observational study. Ann Trop Med Parasitol. 2006 Jun;100(4):363-70. doi: 10.1179/136485906X112158.
PubMed 16762116Phongmany S, Rolain JM, Phetsouvanh R, Blacksell SD, Soukkhaseum V, Rasachack B, Phiasakha K, Soukkhaseum S, Frichithavong K, Chu V, Keolouangkhot V, Martinez-Aussel B, Chang K, Darasavath C, Rattanavong O, Sisouphone S, Mayxay M, Vidamaly S, Parola P, Thammavong C, Heuangvongsy M, Syhavong B, Raoult D, White NJ, Newton PN. Rickettsial infections and fever, Vientiane, Laos. Emerg Infect Dis. 2006 Feb;12(2):256-62. doi: 10.3201/eid1202.050900.
PubMed 16494751Miah MT, Rahman S, Sarker CN, Khan GK, Barman TK. Study on 40 cases of rickettsia. Mymensingh Med J. 2007 Jan;16(1):85-8. doi: 10.3329/mmj.v16i1.259.
PubMed 17344787Coleman RE, Monkanna T, Linthicum KJ, Strickman DA, Frances SP, Tanskul P, Kollars TM Jr, Inlao I, Watcharapichat P, Khlaimanee N, Phulsuksombati D, Sangjun N, Lerdthusnee K. Occurrence of Orientia tsutsugamushi in small mammals from Thailand. Am J Trop Med Hyg. 2003 Nov;69(5):519-24.
PubMed 14695089Tsay RW, Chang FY. Serious complications in scrub typhus. J Microbiol Immunol Infect. 1998 Dec;31(4):240-4.
PubMed 10496165Thap LC, Supanaranond W, Treeprasertsuk S, Kitvatanachai S, Chinprasatsak S, Phonrat B. Septic shock secondary to scrub typhus: characteristics and complications. Southeast Asian J Trop Med Public Health. 2002 Dec;33(4):780-6.
PubMed 12757226Sirisanthana V, Puthanakit T, Sirisanthana T. Epidemiologic, clinical and laboratory features of scrub typhus in thirty Thai children. Pediatr Infect Dis J. 2003 Apr;22(4):341-5. doi: 10.1097/01.inf.0000059400.23448.57.
PubMed 12690274Kim DM, Chung JH, Yun NR, Kim SW, Lee JY, Han MA, Lee YB. Scrub typhus meningitis or meningoencephalitis. Am J Trop Med Hyg. 2013 Dec;89(6):1206-11. doi: 10.4269/ajtmh.13-0224. Epub 2013 Oct 28.
PubMed 24166036Kim DM, Kim SW, Choi SH, Yun NR. Clinical and laboratory findings associated with severe scrub typhus. BMC Infect Dis. 2010 Apr 30;10:108. doi: 10.1186/1471-2334-10-108.
PubMed 20433689LEVINE HD. Pathologic study of thirty-one cases of scrub typhus fever with especial reference to the cardiovascular system. Am Heart J. 1946 Mar;31:314-28. doi: 10.1016/0002-8703(46)90313-4. No abstract available.
PubMed 21018737Paris DH, Phetsouvanh R, Tanganuchitcharnchai A, Jones M, Jenjaroen K, Vongsouvath M, Ferguson DP, Blacksell SD, Newton PN, Day NP, Turner GD.
Paris DH, Phetsouvanh R, Tanganuchitcharnchai A, Jones M, Jenjaroen K, Vongsouvath M, Ferguson DP, Blacksell SD, Newton PN, Day NP, Turner GD. Orientia tsutsugamushi in human scrub typhus eschars shows tropism for dendritic cells and monocytes rather than endothelium. PLoS Negl Trop Dis. 2012 Jan;6(1):e1466. doi: 10.1371/journal.pntd.0001466. Epub 2012 Jan 10.
PubMed 22253938Moron CG, Popov VL, Feng HM, Wear D, Walker DH. Identification of the target cells of Orientia tsutsugamushi in human cases of scrub typhus. Mod Pathol. 2001 Aug;14(8):752-9. doi: 10.1038/modpathol.3880385.
PubMed 11504834Gillespie JJ, Ammerman NC, Beier-Sexton M, Sobral BS, Azad AF. Louse- and flea-borne rickettsioses: biological and genomic analyses. Vet Res. 2009 Mar-Apr;40(2):12. doi: 10.1051/vetres:2008050. Epub 2008 Nov 28.
PubMed 19036234Civen R, Ngo V. Murine typhus: an unrecognized suburban vectorborne disease. Clin Infect Dis. 2008 Mar 15;46(6):913-8. doi: 10.1086/527443.
PubMed 18260783
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rickettsial Disease in Febrile Hospitalised Patients in a Tertiary Referral Hospital in Bangladesh
- ClinicalTrials.gov ID
- NCT02339259
- Acronym / sponsor ID
- BAKMAL1408
- Conditions
- Rickettsial Disease
- Keywords
- Rickettsial disease, Febrile, Murine typhus, Scrub typhus, Diagnostic test, Clinical features
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 416 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Chittagong Medical College and Hospital, University of Amsterdam, Menzies School of Health Research, Mahidol Oxford Tropical Medicine Research Unit
- Study start
- Aug 2014 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 15 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Proposed activities:
The primary objective of this study are to assess the clinical features of patients with scrub or murine typhus infections presenting to CMCH. The proportion of cases screened for malaria and typhus who are diagnosed with scrub and murine typhus during the study period will be calculated, and the data made available for future empiric treatment guideline preparation.
Rapid antibody-based tests for scrub typhus and murine typhus will be made available for physicians to request alongside malaria testing in CMCH. Consenting febrile patients admitted to CMCH will be enrolled and history and clinical examination recorded. A sample will be taken for reference diagnostic testing at a later stage (including indirect fluorescent antibody (IFA) and real time PCR for scrub typhus and Rickettsia spp.)16. Samples will also be taken for testing of markers of pathophysiology (endothelial dysfunction neutrophil activation, cell death, cytokines). Where an eschar is found, the scab will be removed for real time-PCR. Where possible, patients will be invited back for a follow up 14 days after enrolment and a sample collected for paired serology assayed by IFA testing. Ultrasound based hemodynamic assessment will be performed to assess volume status and evidence of cardiac dysfunction.
The results of the ultrasound based hemodynamic assessment will be used to provide baseline information on patients with O. tsutsugamushi and Rickettsia spp. infection and other infections. This information may be used to plan further studies on the fluid management of these conditions.
Study design:
This is an observational study with no intervention. Febrile patients admitted to CMCH who have had malaria film and scrub typhus and murine typhus rapid test will be screened for enrolment. If patients meet the entry criteria, they will be enrolled after written informed consent has been given. Enrolled patients will then undergo study procedures (blood tests, physical examinations, follow-up).
Overall Description of study Participants:
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.
During the study period, we aim to prospectively recruit consecutive patients until 300 patients are enrolled for whom there are paired admission and convalescent samples.
Data obtained from the malaria patients and patients without malaria or typhus will be used as comparator groups for the patients with typhus. The data from the 300 consecutive patients will be used to prospectively assess the sensitivity and specificity of the typhus diagnostic tests.
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 with paired serology and 30 healthy subjects).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Febrile patients | – | Other: ObservationFebrile patients admitted to CMCH who have had malaria film and scrub typhus and murine typhus rapid test will be screened for enrolment. |
| Healthy | – | Other: ObservationHealthy subjects with no recent history of fever will be recruited to provide control samples for the blood and plasma assays. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (8 listed)
- Consent refused, or no adult (≥18 years) relative or guardian present to give consent in the case the patient lacks capacity to give consent.
- Healthy subjects Inclusion
- No known acute or chronic medical conditions
- Asymptomatic
- No febrile illness in the last 2 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation | Other | Febrile patients, Healthy |
Primary outcome
The clinical features of severe and uncomplicated scrub typhus and murine typhus in Bangladeshi patients
Time frame: 1 year
5 secondary outcomes
Evaluation of markers of disease severity
Time frame: 1 year
Hemodynamic status of patients with typhus
Time frame: 1 year
Diagnostic accuracy of rapid diagnostic tests for scrub and murine typhus
Time frame: 1 year
Proportion of acute rickettsial illnesses in patients screened for malaria
Time frame: 1 year
Identification of vectors harbouring Rickettsia/Orientia spp.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2019.
- Background: PubMed 16762116Suttinont C, Losuwanaluk K, Niwatayakul K, Hoontrakul S, Intaranongpai W, Silpasakorn S, Suwancharoen D, Panlar P, Saisongkorh W, Rolain JM, Raoult D, Suputtamongkol Y. Causes of acute, undifferentiated, febrile illness in rural Thailand: results of a prospective observational study. Ann Trop Med Parasitol. 2006 Jun;100(4):363-70. doi: 10.1179/136485906X112158.
- Background: PubMed 16494751Phongmany S, Rolain JM, Phetsouvanh R, Blacksell SD, Soukkhaseum V, Rasachack B, Phiasakha K, Soukkhaseum S, Frichithavong K, Chu V, Keolouangkhot V, Martinez-Aussel B, Chang K, Darasavath C, Rattanavong O, Sisouphone S, Mayxay M, Vidamaly S, Parola P, Thammavong C, Heuangvongsy M, Syhavong B, Raoult D, White NJ, Newton PN. Rickettsial infections and fever, Vientiane, Laos. Emerg Infect Dis. 2006 Feb;12(2):256-62. doi: 10.3201/eid1202.050900.
- Background: PubMed 17344787Miah MT, Rahman S, Sarker CN, Khan GK, Barman TK. Study on 40 cases of rickettsia. Mymensingh Med J. 2007 Jan;16(1):85-8. doi: 10.3329/mmj.v16i1.259.
- Background: PubMed 14695089Coleman RE, Monkanna T, Linthicum KJ, Strickman DA, Frances SP, Tanskul P, Kollars TM Jr, Inlao I, Watcharapichat P, Khlaimanee N, Phulsuksombati D, Sangjun N, Lerdthusnee K. Occurrence of Orientia tsutsugamushi in small mammals from Thailand. Am J Trop Med Hyg. 2003 Nov;69(5):519-24.
- Background: PubMed 10496165Tsay RW, Chang FY. Serious complications in scrub typhus. J Microbiol Immunol Infect. 1998 Dec;31(4):240-4.
- Background: PubMed 12757226Thap LC, Supanaranond W, Treeprasertsuk S, Kitvatanachai S, Chinprasatsak S, Phonrat B. Septic shock secondary to scrub typhus: characteristics and complications. Southeast Asian J Trop Med Public Health. 2002 Dec;33(4):780-6.
- Background: PubMed 12690274Sirisanthana V, Puthanakit T, Sirisanthana T. Epidemiologic, clinical and laboratory features of scrub typhus in thirty Thai children. Pediatr Infect Dis J. 2003 Apr;22(4):341-5. doi: 10.1097/01.inf.0000059400.23448.57.
- Background: PubMed 24166036Kim DM, Chung JH, Yun NR, Kim SW, Lee JY, Han MA, Lee YB. Scrub typhus meningitis or meningoencephalitis. Am J Trop Med Hyg. 2013 Dec;89(6):1206-11. doi: 10.4269/ajtmh.13-0224. Epub 2013 Oct 28.
- Background: PubMed 20433689Kim DM, Kim SW, Choi SH, Yun NR. Clinical and laboratory findings associated with severe scrub typhus. BMC Infect Dis. 2010 Apr 30;10:108. doi: 10.1186/1471-2334-10-108.
- Background: PubMed 21018737LEVINE HD. Pathologic study of thirty-one cases of scrub typhus fever with especial reference to the cardiovascular system. Am Heart J. 1946 Mar;31:314-28. doi: 10.1016/0002-8703(46)90313-4. No abstract available.
- BackgroundParis DH, Phetsouvanh R, Tanganuchitcharnchai A, Jones M, Jenjaroen K, Vongsouvath M, Ferguson DP, Blacksell SD, Newton PN, Day NP, Turner GD.
- Background: PubMed 22253938Paris DH, Phetsouvanh R, Tanganuchitcharnchai A, Jones M, Jenjaroen K, Vongsouvath M, Ferguson DP, Blacksell SD, Newton PN, Day NP, Turner GD. Orientia tsutsugamushi in human scrub typhus eschars shows tropism for dendritic cells and monocytes rather than endothelium. PLoS Negl Trop Dis. 2012 Jan;6(1):e1466. doi: 10.1371/journal.pntd.0001466. Epub 2012 Jan 10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amir Hossain, Professor Md principal investigator
Chittagong Medical College and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rickettsial Disease, run by University of Oxford at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The clinical features of severe and uncomplicated scrub typhus and murine typhus in Bangladeshi patients (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02339259, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2019.