Rapid Diagnostic Tests and Clinical/Laboratory Predictors of Tropical Diseases In Patients With Persistent Fever in Cambodia, Nepal, Democratic Republic of the Congo and Sudan (NIDIAG-Fever)
NCT ID: NCT01766830
Last Updated: 2016-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1927 participants
INTERVENTIONAL
2013-01-31
2016-07-31
Brief Summary
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In resource-limited settings, clinical algorithms constitute a valuable aid to health workers, as they facilitate the therapeutic decision in the absence of good laboratory capacities. There is a critical lack of appropriate diagnostic tools to guide treatment of NTDs. While clinical algorithms have been developed for some NTDs, in most cases they remain empirical. Besides, they rarely take into account local prevalence data, do not adequately represent the spectrum of patients and differential diagnosis at the primary care level and often have not been properly validated. The purpose of the study is to develop evidence-based Rapid Diagnostic Test (RDT)-supported diagnostic guidelines for patients with persistent fever (≥ 1 week) in the Democratic Republic of the Congo (DRC), Sudan, Cambodia and Nepal.
Detailed Description
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The persistent fever syndrome targeted by NIDIAG is defined as presence of fever for at least one week. The list of diseases - both NTD and other Infectious Diseases (ID) - that frequently cause persistent (≥1 week) fever in the study countries includes: Visceral Leishmaniasis (VL), Human Africa Trypanosomiasis (HAT), Enteric (typhoid, paratyphoid) fever, Malaria, Brucellosis, Melioidosis, Tuberculosis, Amoebic liver abscess, Relapsing fever, HIV, Rickettsial diseases, and Leptospirosis. The study will try to identify clinical and laboratory predictors of these diseases as well as validate existing RDTs.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Phase 3 Diagnostic
A total of 10 RDTs will be assessed in the patients cohort for the respective target condition
rk28 ICT
rk28 ICT is an immunochromatographic assay intended for qualitative detection of IgG antibodies directed towards VL in human serum, plasma or whole blood. It is manufactured by EASE-Medtrend (Shanghai, China)
IT LEISH (rK39)
IT LEISH is an immuno-chromatographic test, using the recombinant antigen K39, to detect the presence of antibodies against Leishmania spp. It is manufactured by BioRad laboratories, USA.
Immunochromatographic HAT test
This is a lateral flow immunochromatographic test manufactured by Standard Diagnostics (Korea) in collaboration with FIND.
HAT Serostrip
The HAT Serostrip is an immunochromatographic assay developed by Coris BioConcept, France, which is designed for remote field use in individual HAT suspects.
Card Agglutination Trypanosoma Test (CATT)-10
The Card Agglutination Trypanosoma test (CATT) has been used for many years at large scale for mass screening of mostly asymptomatic individuals (CATT-R250). Unfortunately, its operating characteristics have only been evaluated in the context of patients with persistent fever. Although it is not strictly an RDT, the CATT is rather easily performed in remote settings, in particular since a new and more robust format (CATT-D10) allows to test a lower number of patients in peripheral health facilities. It is manufactured by the Institute of Tropical Medicine of Antwerp, Belgium.
Typhidot M
The Typhidot M test is a dot enzyme immunoassay that detects IgM and IgG directed against Salmonella typhi. It is manufactured by Reszon Diagnostics International, Malaysia
S. typhi IgM/IgG
The Salmonella typhi IgG/IgM Rapid Test is an immunochromatographic assay for the qualitative differential detection of IgG and IgM antibodies to Salmonella typhi in human serum, plasma or whole blood. It is manufactured by Standard Diagnostics (Korea)
Test-it Typhoid IgM
Test-it Typhoid IgM lateral flow assay is a one-step immunochromatographic assay which uses a lipopolysaccharide (LPS) antigen derived from salmonella typhi for the detection of specific IgM antibodies. It is manufactured by Life Assay, South Africa.
Test-it Leptospirosis IgM
The Test-it™ Leptospira lateral flow device detects IgM antibodies in humans against Leptospira in whole blood or serum. It is manufactured by Life Assay, South Africa
Leptospira IgG/IgM
This test enables the differential detection of IgG and IgM antibodies to Leptospira interrogans. It is manufactured by Standard Diagnostics, Korea
Interventions
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rk28 ICT
rk28 ICT is an immunochromatographic assay intended for qualitative detection of IgG antibodies directed towards VL in human serum, plasma or whole blood. It is manufactured by EASE-Medtrend (Shanghai, China)
IT LEISH (rK39)
IT LEISH is an immuno-chromatographic test, using the recombinant antigen K39, to detect the presence of antibodies against Leishmania spp. It is manufactured by BioRad laboratories, USA.
Immunochromatographic HAT test
This is a lateral flow immunochromatographic test manufactured by Standard Diagnostics (Korea) in collaboration with FIND.
HAT Serostrip
The HAT Serostrip is an immunochromatographic assay developed by Coris BioConcept, France, which is designed for remote field use in individual HAT suspects.
Card Agglutination Trypanosoma Test (CATT)-10
The Card Agglutination Trypanosoma test (CATT) has been used for many years at large scale for mass screening of mostly asymptomatic individuals (CATT-R250). Unfortunately, its operating characteristics have only been evaluated in the context of patients with persistent fever. Although it is not strictly an RDT, the CATT is rather easily performed in remote settings, in particular since a new and more robust format (CATT-D10) allows to test a lower number of patients in peripheral health facilities. It is manufactured by the Institute of Tropical Medicine of Antwerp, Belgium.
Typhidot M
The Typhidot M test is a dot enzyme immunoassay that detects IgM and IgG directed against Salmonella typhi. It is manufactured by Reszon Diagnostics International, Malaysia
S. typhi IgM/IgG
The Salmonella typhi IgG/IgM Rapid Test is an immunochromatographic assay for the qualitative differential detection of IgG and IgM antibodies to Salmonella typhi in human serum, plasma or whole blood. It is manufactured by Standard Diagnostics (Korea)
Test-it Typhoid IgM
Test-it Typhoid IgM lateral flow assay is a one-step immunochromatographic assay which uses a lipopolysaccharide (LPS) antigen derived from salmonella typhi for the detection of specific IgM antibodies. It is manufactured by Life Assay, South Africa.
Test-it Leptospirosis IgM
The Test-it™ Leptospira lateral flow device detects IgM antibodies in humans against Leptospira in whole blood or serum. It is manufactured by Life Assay, South Africa
Leptospira IgG/IgM
This test enables the differential detection of IgG and IgM antibodies to Leptospira interrogans. It is manufactured by Standard Diagnostics, Korea
Eligibility Criteria
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Inclusion Criteria
* ≥ 5 years old (18 years onward in Cambodia)
Exclusion Criteria
* unable in the study physician's opinion to comply with the study requirements
* existing laboratory confirmed diagnosis
* need of immediate intensive care due to shock or respiratory distress
5 Years
ALL
No
Sponsors
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Institute of Tropical Medicine, Belgium
OTHER
B.P. Koirala Institute of Health Sciences
OTHER
Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
OTHER
University of Khartoum
OTHER
Sihanouk Hospital Center of HOPE
OTHER
University Hospital, Geneva
OTHER
Responsible Party
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Francois CHAPPUIS
Professor
Principal Investigators
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François Chappuis, MD, PhD
Role: STUDY_DIRECTOR
University Hospital, Geneva
Locations
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Sihanouk Hospital Center of HOPE
Phnom Penh, , Cambodia
Reference Hospital Mosango and Kasay Health Centre
Mosango, Bandundu, Democratic Republic of the Congo
Institut National de Recherche Biomédicale
Kinshasa, , Democratic Republic of the Congo
Dhankuta District hospital
Dhankutā, Koshi Zone, Nepal
BP Koirala Institute of Health Sciences
Dharān, , Nepal
Tabarak Allah Hospital
Tabarak Allah, Al Qaḑārif, Sudan
University of Khartoum
Khartoum, , Sudan
Countries
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References
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Bottieau E, Van Duffel L, El Safi S, Koirala KD, Khanal B, Rijal S, Bhattarai NR, Phe T, Lim K, Mukendi D, Kalo JL, Lutumba P, Barbe B, Jacobs J, Van Esbroeck M, Foque N, Tsoumanis A, Parola P, Yansouni CP, Boelaert M, Verdonck K, Chappuis F. Etiological spectrum of persistent fever in the tropics and predictors of ubiquitous infections: a prospective four-country study with pooled analysis. BMC Med. 2022 May 2;20(1):144. doi: 10.1186/s12916-022-02347-8.
Alirol E, Horie NS, Barbe B, Lejon V, Verdonck K, Gillet P, Jacobs J, Buscher P, Kanal B, Bhattarai NR, El Safi S, Phe T, Lim K, Leng L, Lutumba P, Mukendi D, Bottieau E, Boelaert M, Rijal S, Chappuis F. Diagnosis of Persistent Fever in the Tropics: Set of Standard Operating Procedures Used in the NIDIAG Febrile Syndrome Study. PLoS Negl Trop Dis. 2016 Nov 3;10(11):e0004749. doi: 10.1371/journal.pntd.0004749. eCollection 2016 Nov.
Related Links
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NIDIAG Consortium website
Other Identifiers
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260260
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
WP2-01-FEV
Identifier Type: -
Identifier Source: org_study_id