Aspects Cliniques, Prise en Charge et Surveillance Des Maladies fébriles en RDC
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Describe and compare the use of antibiotics for patients with community-acquired febrile illness with different types of support
研究概览
简要总结
The epidemiology and outcome of febrile illnesses in the Democratic Republic of Congo (DRC) is poorly documented. The FIKI² study, a prospective observational study of community-acquired febrile illnesses coordinated by ITM and INRB and conducted at 2 clinical sites from 2021 to 2023, has deepened the knowledge of clinical presentation, etiology, outcome and profile of inflammatory/infectious biomarkers (white blood cells and C-reactive protein, or CRP).
The management of febrile illnesses remains fraught with clinical challenges. Overuse of antibiotics in primary care remains a reality in the field, and has been observed in several studies, including FIKI². A number of initiatives are underway to address this problem, such as the use of biomarkers, the development of treatment guidelines and electronic decision support systems. The FIKI² study highlighted the potential role of CRP in rationalizing antibiotic use. In parallel, the 'AWARE antibiotic book' was published at the end of 2022 by the WHO, providing recommendations on the choice (or otherwise) of antibiotic therapy for over 30 common clinical infections, in both primary care and hospital settings.
Based on the results of the FIKI² study, the main aim of the FI-CARE study is to investigate the impact of these new tools (CRP biomarker, AWARE antibiotic book, and electronic decision support systems) on first-line antibiotic use. Secondly, the study will consolidate previous results from FIKI² sites in terms of monitoring the etiologies of community-acquired febrile illnesses (particularly arboviruses); and reinforce this monitoring at new sites (depending on opportunities). This complementary study will also pursue FIKI²'s strategic objectives of strengthening clinical research capacity and consolidating biobanks in the DRC.
FI-CARE is a prospective, observational, multicenter cohort study of adults and children presenting to the emergency department or outpatient clinic with community-acquired febrile illness. A laboratory component with sample storage in a biobank is added in a modular fashion according to laboratory and research capacities, epidemiological interest and available funds.
详细描述
The management of febrile illnesses in low resource settings remains fraught with clinical challenges. Overuse of antibiotics in primary care remains a reality in the field, and has been observed in several studies. A number of initiatives are underway to address this problem, such as the use of biomarkers, the development of treatment guidelines and electronic decision support systems. The 'AWARE antibiotic book' was published at the end of 2022 by the WHO, providing recommendations on the choice (or otherwise) of antibiotic therapy for over 30 common clinical infections, in both primary care and hospital settings.
As in most sub-Saharan African countries, very little data is available in the Democratic Republic of Congo (DRC) on the epidemiology, clinical presentation, causes and outcome of febrile illnesses, and research capacity is generally very weak.
FIKI² was a bi-centric observational study of febrile illnesses conducted between March 29, 2021 and October 9, 2023 at two newly established research sites in the DRC: (i) the pediatric emergency department of the Hôpital Général de Référence de Kinshasa (HGRK) - now the Centre Hospitalier Universitaire Renaissance (CHUR) - , and (ii) the emergency and outpatient department of the Hôpital Général de Référence (HGR) of the Institut Médical Evangélique (IME) in Kimpese.
The study prospectively recruited patients presenting with fever and collected data on clinical and laboratory characteristics at the time of consultation and during a three-week follow-up period. The study included the routine performance of a thick smear and/or RDT for malaria, in line with routine care, as well as the performance of an RDT for dengue and the measurement of CRP, hemoglobin, white blood cell count and differentiation as study laboratory procedures.
The study was also integrated for part of its duration into a blood culture surveillance project (protocol approved in Belgium and DRC). Blood samples were also collected for long-term storage and secondary research during the second phase of the study for consenting patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ongoing fever objectified at presentation, or documented at home or other health center within 24 hours prior to presentation, defined as: axillary or tympanic temperature > 37.5°C, or oral or rectal temperature > 38°C.
- •Opportunity for contact between patient (or designated relative) and study team on days 7, 14 and
- •Informed consent to participate signed by the patient (adult) or a legally acceptable representative (child or patients whose condition does not allow them to sign informed consent), with the assent of children aged 12 and over, wherever possible.
排除标准
- •Child less than two months old.
- •Hospitalization of > 48h in the last 14 days.
研究组 & 干预措施
patients with febrile illness
Patients with febrile illness matching inclusion/exclusion criteria presenting at emergency department or outpatient clinic. At this moment one site has been selected. Other sites might be added in the future given rise to other cohorts of febrile patients
结局指标
主要结局
Describe and compare the use of antibiotics for patients with community-acquired febrile illness with different types of support
时间窗: at enrollment
Describe and compare the use of antibiotics for patients with community-acquired febrile illness with different types of support that can be used throughout the study to guide patient management (e.g. algorithm combining presenting syndrome with CRP results; etiological approach based on the WHO clinical guide (AWARE antibiotic book) or other; or any new electronic decision-making support). Endpoints: Frequency of antibiotics and class of antibiotics used with different types of support
Describe the appropriateness of antibiotics for patients with community-acquired febrile illness with different types of support
时间窗: at enrollment
Describe the appropriateness of antibiotics for patients with community-acquired febrile illness with different types of support that can be used throughout the study to guide patient management (e.g. algorithm combining presenting syndrome with CRP results; etiological approach based on the WHO clinical guide (AWARE antibiotic book) or other; or any new electronic decision-making support). Endpoints: \- Appropriateness of antibiotic use (according to local clinical guidelines if available or WHO)
Describe and compare adherence to different types of support used
时间窗: at enrollment
Describe and compare adherence to the tools used to guide patient management (syndromic algorithm; AWARE antibiotic book or other etiological guide; or an electronic decision support). Endpoints: \- frequency of adherence to recommendations
Describe reasons for non-adherence to different types of support used
时间窗: at enrollment
Describe reasons for non-adherence to the tools used to guide patient management (syndromic algorithm; AWARE antibiotic book or other etiological guide; or an electronic decision support). Endpoints: \- frequency of reasons for non-adherence
Describe clinical presentation of febrile illnesses in the DRC.
时间窗: from enrollment to the end of the 3 week follow-up period
endpoints: \- Frequency of specific symptoms
Describe laboratory presentation of febrile illnesses in the DRC.
时间窗: from enrollment to the end of the 3 week follow-up period
endpoints: \- Frequency of laboratory deviations
Describe severity of febrile illnesses in the DRC.
时间窗: from enrollment to the end of the 3 week follow-up period
endpoints: \- frequency of presence of severity criteria
Describe etiology of febrile illnesses in the DRC.
时间窗: from enrollment to the end of the 3 week follow-up period
endpoints: \- Frequency of specific and syndromic diagnoses
Evaluate the frequency of hospital admissions for febrile illnesses in the DRC.
时间窗: from enrollment to the end of the 3 week follow-up period
endpoints: \- Proportion of patients with a primary or secondary hospital admission
Evaluate the frequency of secondary visits for febrile illnesses in the DRC.
时间窗: from enrollment to the end of the 3 week follow-up period
endpoints: \- Proportion of patients with secondary visits
Describe outcome of febrile illnesses in the DRC.
时间窗: from enrollment to the end of the 3 week follow-up period
endpoints: \- Proportion of participants resolved, unresolved and dead by day 21
次要结局
- Describe the biomarker profile (CRP, white blood cell count with differentiation) at inclusion of patients with febrile illnesses, and its correlation with specific and syndromic diagnoses and outcome.(at inclusion)
- Evaluate the field accuracy of clinical case definitions currently used for national surveillance of the epidemic-prone subgroup.(from enrollment to the end of the 3 week follow-up period)
- Evaluate the timeliness of reporting for diseases under national surveillance, of the epidemic-prone subgroup.(from enrollment to the end of the 3 week follow-up period)