Febrile Illness in Kinshasa and Kimpese

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1046 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

Study Completion Date

2023-09-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a bi-centric prospective observational cohort study of adults and children presenting to the emergency room or outpatient department with community febrile illness (with or without signs of focalization) in 2 clinical sites (hospitals) in the DRC. The study will describe the epidemiology, clinical aspects, severity, management and outcome of febrile illnesses using data collected during routine diagnostic and therapeutic procedures.

Each patient will be followed for 21 days. The follow-up will include

* Daily visits for hospitalized patients,
* Telephone calls (or study center visit or home visit) on days 7, 14 and 21 for outpatients and discharged patients.

The study has been amended (EC UZA approval in June 2021) to perform a set of laboratory analyses in the partners institutions and at the ITM. We aim as a new primary objective at describing the profile of different biomarkers (C-reactive protein and white blood cell count with differentiation) in participants enrolled with febrile illness, and as secondary objectives to correlate them with outcome (assessed at day 21) and with several etiological diagnoses, especially malaria (as assessed by rapid diagnostic test and blood smear). The purpose is to investigate the potential diagnostic and prognostic value of these biomarkers which are increasingly available at the point-of-care.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Non-inferiority Trial of Conditional vs Universal Follow up for Children With Fever in Democratic Republic of Congo

NCT02595827

Fever

COMPLETED PHASE3

Health Itinerary of Young Children With Suspected Bloodstream Infection in Kisantu General Referral Hospital, DR Congo

NCT04289688

Bloodstream Infection Health Care Utilization Malaria,Falciparum +2 more

COMPLETED

Febrile Illness in Guinea

NCT06122259

Febrile Illness

RECRUITING

Treating Non-typhoidal Salmonella Bloodstream Infections in Children Under Five in DR Congo: a Cohort Study

NCT04850677

Blood-stream Infections Salmonella Infection Non-Typhoid

COMPLETED

Effectiveness Study of New Generation Bednets in the Context of Conventional Insecticide Resistance in the Democratic Republic of the Congo

NCT03289663

Insecticide Resistance

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Febrile Illness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Observational study

No intervention (observational study in human participants)

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Ongoing and objectified fever at presentation, or documented at home or other health center within 24 hours prior to presentation, defined by:

* Axillary or tympanic temperature \> 37.5°C OR
* Oral or rectal temperature \> 38°C
2. Possibility of contact between the patient (or designated relative) and the study team on days 7, 14 and 21
3. Informed consent signed by the patient (adults) or a legally acceptable representative (children or patients whose condition does not allow them to sign informed consent), with the consent of children as young as 12 years of age, whenever possible.