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OpenTrials
Completed

NCT Number: NCT02656862

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

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.

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Key information

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Lisungi Health Center

Kinshasa, Democratic Republic of the Congo

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

Primary outcomes

  1. Proportion of key pathogens among study participants with 'undifferentiated fever'

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Institute of Tropical Medicine, Belgium

Other

Collaborators

  • Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
  • Universiteit Antwerpen
  • University of Kinshasa

Registry information

Acronym: RESFANDI

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 15, 2016
Registry last updated
Mar 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.