Causes of Acute Undifferentiated Fever in Outpatients in the Democratic Republic of Congo (RESFANDI)

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.

Study Overview

• Status: Completed
• Conditions: Undifferentiated Acute Fever
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Actual): 301

Contacts and Locations

Study Locations

• Congo, The Democratic Republic of the
  • Kinshasa, Congo, The Democratic Republic of the
    • Lisungi Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study will take place in the Lisungi Health centre, Pumbu. Pumbu is a health area of about 14 000 inhabitants, belonging to the municipality of peri-urban Mont Ngafula 1, at the southern side of Kinshasa. The Lisungi health centre is the only public health facility in the health area, with on average 250 consultations/week. About 70% of attending patients have fever as reason for consultation.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of key pathogens among study participants with 'undifferentiated fever'	The key pathogens will be identified through specific laboratory diagnostic tests on the blood/serum of included patients.	At consultation over a period of 6 months

Collaborators and Investigators

• Sponsor: Institute of Tropical Medicine, Belgium
• Collaborators: Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo; Universiteit Antwerpen; Université de Kinshasa, DRC
• Investigators: Principal Investigator: Pascal Lutumba, PhD, Institut National de Recherche Biomédicale (INRB), Kinshasa

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (ACTUAL): December 31, 2016
• Study Completion (ACTUAL): December 31, 2016

Study Registration Dates

• First Submitted: January 5, 2016
• First Submitted That Met QC Criteria: January 14, 2016
• First Posted (ESTIMATE): January 15, 2016

Study Record Updates

• Last Update Posted (ACTUAL): March 8, 2017
• Last Update Submitted That Met QC Criteria: March 7, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Temperature Changes; Fever
• Other Study ID Numbers: RESFANDI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED