Clinical trial NCT02656862: Causes of Acute Undifferentiated Fever in Outpatients in the Democratic Republic of Congo
Official title: Causes of Acute Undifferentiated Fever in Outpatients in the Democratic Republic of Congo
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Undifferentiated Acute Fever
Lead sponsor: Institute of Tropical Medicine, Belgium
Sponsor class: OTHER
Collaborators: name: Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
name: Universiteit Antwerpen
name: Université de Kinshasa, DRC
First posted: 2016-01-15
Enrollment: 301
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.


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

Primary outcomes:
measure: Proportion of key pathogens among study participants with 'undifferentiated fever'
timeFrame: At consultation over a period of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kinshasa
country: Congo, The Democratic Republic of the
facility: Lisungi Health Center
Study officials:
affiliation: Institut National de Recherche Biomédicale (INRB), Kinshasa
name: Pascal Lutumba, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.