Ignite Creation Date:
2024-05-06 @ 8:03 AM
Last Modification Date:
2024-10-26 @ 11:55 AM
Study NCT ID:
NCT02656862
Status:
COMPLETED
Last Update Posted:
2017-03-08
First Post:
2016-01-05
Brief Title:
Causes of Acute Undifferentiated Fever in Outpatients in the Democratic Republic of Congo
Sponsor:
Institute of Tropical Medicine Belgium
Organization:
Institute of Tropical Medicine Belgium
Study Overview
Official Title:
Causes of Acute Undifferentiated Fever in Outpatients in the Democratic Republic of Congo
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESFANDI
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None