Causes of Acute Undifferentiated Fever in Outpatients in the Democratic Republic of Congo (RESFANDI)
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|ClinicalTrials.gov Identifier: NCT02656862|
Recruitment Status : Completed
First Posted : January 15, 2016
Last Update Posted : March 8, 2017
Fever is one of the main reasons for outpatient consultations in sub-saharan Africa. Following the introduction of malaria RDTs, clinicians face a high number of malaria-negative patients for whom they do not have a clear diagnosis. Through clinical history and examination, acute fever patients are categorized into: acute respiratory infections, urinary tract infections and other focal infections, diarrheal fevers and undifferentiated fevers. The latter being patients where no focal source of infections can be found during the consultation visit. In this proposal, the investigators focus on these acute undifferentiated fevers in an outpatient clinic.
These fevers have the challenge of few point-of-care tests (POCT) available for the clinicians to identify the etiology of fever and guide treatment in resource-limited countries. As a consequence, over-prescription of antibiotics has increased. In order to improve patient outcomes while supporting judicious use of antimicrobials, there is an urgent need to change the management of febrile patients in low-income countries. This can only be achieved by providing evidence-based clinical guidelines for the management of these acute febrile patients. To develop such guidelines, epidemiological data on etiologies of undifferentiated fever need to be generated. The investigators will evaluate pathogen infection (such as dengue, chikungunya and others) in 640 patients ≥ 2 years old with acute undifferentiated fever. To evaluate the existence of aspecific and subclinical infections and co-infections, the investigators will also test a subsample of 200 patients with ARI, UTI, diarrheal fever and malaria. The investigators expect to have as main results: proportions of each syndrome among fever patients, key pathogens associated with undifferentiated fever and their clinical presentation and demographic characteristics.
|Condition or disease||Intervention/treatment|
|Undifferentiated Acute Fever||Other: No intervention|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||301 participants|
|Target Follow-Up Duration:||1 Day|
|Official Title:||Causes of Acute Undifferentiated Fever in Outpatients in the Democratic Republic of Congo|
|Study Start Date :||October 2015|
|Actual Primary Completion Date :||December 31, 2016|
|Actual Study Completion Date :||December 31, 2016|
- Proportion of key pathogens among study participants with 'undifferentiated fever' [ Time Frame: At consultation over a period of 6 months ]The key pathogens will be identified through specific laboratory diagnostic tests on the blood/serum of included patients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656862
|Congo, The Democratic Republic of the|
|Lisungi Health Center|
|Kinshasa, Congo, The Democratic Republic of the|
|Principal Investigator:||Pascal Lutumba, PhD||Institut National de Recherche Biomédicale (INRB), Kinshasa|