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)

NACompletedINTERVENTIONAL
Enrollment

1,927

Participants

Timeline

Start Date

January 31, 2013

Primary Completion Date

October 31, 2014

Study Completion Date

July 31, 2016

Conditions
Visceral LeishmaniasisHuman African TrypanosomiasisEnteric FeverMelioidosisBrucellosisLeptospirosisRelapsing FeverRickettsial DiseasesHIVTuberculosisMalariaAmoebic Liver Abscess
Interventions
DEVICE

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)

DEVICE

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.

DEVICE

Immunochromatographic HAT test

This is a lateral flow immunochromatographic test manufactured by Standard Diagnostics (Korea) in collaboration with FIND.

DEVICE

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.

DEVICE

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.

DEVICE

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

DEVICE

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)

DEVICE

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.

DEVICE

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

DEVICE

Leptospira IgG/IgM

This test enables the differential detection of IgG and IgM antibodies to Leptospira interrogans. It is manufactured by Standard Diagnostics, Korea

Trial Locations (7)

Unknown

Sihanouk Hospital Center of HOPE, Phnom Penh

Reference Hospital Mosango and Kasay Health Centre, Mosango

Institut National de Recherche Biomédicale, Kinshasa

Dhankuta District hospital, Dhankutā

BP Koirala Institute of Health Sciences, Dharān

Tabarak Allah Hospital, Tabarak Allah

University of Khartoum, Khartoum

All Listed Sponsors
collaborator

Institute of Tropical Medicine, Belgium

OTHER

collaborator

B.P. Koirala Institute of Health Sciences

OTHER

collaborator

Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo

OTHER

collaborator

University of Khartoum

OTHER

collaborator

Sihanouk Hospital Center of HOPE

OTHER

lead

University Hospital, Geneva

OTHER

NCT01766830 - 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) | Biotech Hunter | Biotech Hunter