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

NCT ID: NCT02656862

Last Updated: 2017-03-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 301 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-12-31

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.

Conditions

Undifferentiated Acute Fever

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Interventions

No intervention

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: collaborator

Universiteit Antwerpen

OTHER

Sponsor Role: collaborator

University of Kinshasa

OTHER

Sponsor Role: collaborator

Institute of Tropical Medicine, Belgium

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pascal Lutumba, PhD

Role: PRINCIPAL_INVESTIGATOR

Institut National de Recherche Biomédicale (INRB), Kinshasa

Locations

Lisungi Health Center

Kinshasa, , Democratic Republic of the Congo

Countries

Democratic Republic of the Congo

References

Proesmans S, Katshongo F, Milambu J, Fungula B, Muhindo Mavoko H, Ahuka-Mundeke S, Inocencio da Luz R, Van Esbroeck M, Arien KK, Cnops L, De Smet B, Lutumba P, Van Geertruyden JP, Vanlerberghe V. Dengue and chikungunya among outpatients with acute undifferentiated fever in Kinshasa, Democratic Republic of Congo: A cross-sectional study. PLoS Negl Trop Dis. 2019 Sep 5;13(9):e0007047. doi: 10.1371/journal.pntd.0007047. eCollection 2019 Sep.

Reference Type: DERIVED

PMID: 31487279 (View on PubMed)

Other Identifiers

RESFANDI

Identifier Type: -

Identifier Source: org_study_id