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

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ClinicalTrials.gov Identifier: NCT02656862
Recruitment Status : Completed
First Posted : January 15, 2016
Last Update Posted : March 8, 2017
Sponsor:
Collaborators:
Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
Universiteit Antwerpen
Université de Kinshasa, DRC
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Undifferentiated Acute Fever Other: No intervention

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Study Type : Observational [Patient Registry]
Actual Enrollment : 301 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: Causes of Acute Undifferentiated Fever in Outpatients in the Democratic Republic of Congo
Study Start Date : October 2015
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656862


Locations
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Congo, The Democratic Republic of the
Lisungi Health Center
Kinshasa, Congo, The Democratic Republic of the
Sponsors and Collaborators
Institute of Tropical Medicine, Belgium
Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
Universiteit Antwerpen
Université de Kinshasa, DRC
Investigators
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Principal Investigator: Pascal Lutumba, PhD Institut National de Recherche Biomédicale (INRB), Kinshasa

Additional Information:

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Responsible Party: Institute of Tropical Medicine, Belgium
ClinicalTrials.gov Identifier: NCT02656862     History of Changes
Other Study ID Numbers: RESFANDI
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: March 8, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Fever
Body Temperature Changes
Signs and Symptoms