Causes of Acute Undifferentiated Fever in Outpatients in the Democratic Republic of Congo

Completed

• Conditions: Undifferentiated Acute Fever

• Registration Number: NCT02656862
• Lead Sponsor: Institute of Tropical Medicine, Belgium

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2016-01-05
• Study First Submitted QC: 2016-01-14
• Study First Posted: 2016-01-15
• Primary Completion: 2016-12-31
• Study Completion: 2016-12-31
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-07
• Last Update Posted: 2017-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 301

Inclusion Criteria

• at least 2 years old
• a history of acute fever (i.e. ≥ 2 days and ≤ 7 days)
• an axillary temperature of ≥37.5°C
• written informed consent obtained;

Exclusion Criteria

• main complaint for consultation is an injury, trauma or poisoning
• hospitalization or delivery in the preceding 2 weeks
• suspicion of meningitis/encephalitis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of key pathogens among study participants with 'undifferentiated fever'	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.

Trial Locations

Locations (1)

Lisungi Health Center; 🇨🇩 Kinshasa, Congo, The Democratic Republic of the