Undifferentiated Acute Fever Clinical Trial
— RESFANDIOfficial title:
Causes of Acute Undifferentiated Fever in Outpatients in the Democratic Republic of Congo
| Verified date | March 2017 |
| Source | Institute of Tropical Medicine, Belgium |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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.
| Status | Completed |
| Enrollment | 301 |
| Est. completion date | December 31, 2016 |
| Est. primary completion date | December 31, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 2 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Congo, The Democratic Republic of the | Lisungi Health Center | Kinshasa |
| Lead Sponsor | Collaborator |
|---|---|
| Institute of Tropical Medicine, Belgium | Institut National de recherche Biomédicale (INRB), Kinshasa, DRC, Université de Kinshasa, DRC, Universiteit Antwerpen |
Congo, The Democratic Republic of the,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |