ISRCTN15023306已完成未知
Characterisation of clinical features, environmental risk factors and immunological interactions in visceral leishmaniasis and malaria co-infections in West Pokot County, Kenya
Academic Medical Center0 个研究点目标入组 754 人开始时间: 2022年7月11日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 754
研究概览
简要总结
2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37068901/ (added 18/04/2023)
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •Inclusion criteria for clinically ill patients in the cross-sectional and case-control household questionnaire study:
- •1. Signed informed consent form of the cross-sectional study. In case of children, informed consent form is signed by parent or legal guardian; additionally, assent is also sought for children aged 12 – 17 years.
- •2. Showing symptoms suggestive of malaria and/or VL.
- •3. Having a laboratory-confirmed malaria diagnosis (positive malaria RDT, or thin and thick blood film, any species, parasite count <250,000/µL of blood) and/or VL diagnosis (DAT titre = 1:3200 and/or positive rk39 RDT).
- •4. Living in the catchment area of the study hospital.
- •Inclusion criteria for healthy controls in the case-control household questionnaire study:
- •1. Signed informed consent form of the questionnaire study. In case of children, informed consent form is signed by parent or legal guardian; additionally, assent is also sought for children aged 12 – 17 years.
- •2. Living in the village of residence of a VL-malaria co-infected participant of the cross-sectional study.
- •3. Showing no symptoms suggestive of malaria and/or VL.
- •4. Having no history of clinical malaria in the preceding 2 weeks.
- •5. Having no history of clinical VL.
- •6. Having a negative malaria diagnosis with RDT.
- •7. Having a negative VL diagnosis with rk39 RDT.
- •Inclusion criteria for clinically ill patients in the follow-up cohort study:
- •1. Included in the cross-sectional study.
- •2. Signed informed consent form of the follow-up study. In case of children, informed consent form is signed by parent or legal guardian; assent is sought for children aged 12 – 17 years.
- •3. Between 6 and 30 years of age.
- •4. Showing symptoms suggestive of malaria and/or VL.
- •5. Having a laboratory-confirmed malaria diagnosis with P. falciparum (parasite count between 1000 and 250,000 /µL of blood) and/or VL diagnosis.
- •6. Being enrolled in the national treatment programme for malaria and/or VL after a laboratory-confirmed diagnosis of either disease.
- •7. Living in the catchment area of the study hospital.
- •Inclusion criteria for patients with asymptomatic infections and healthy endemic controls in follow-up cohort study:
- •1. Signed informed consent form. In case of children, informed consent form is signed by parent or legal guardian; assent is sought for children aged 12 – 17 years.
- •2. Living in the household of one of the clinically ill participants of the follow-up study.
- •3. More than 6 years of age.
- •4. Showing no major symptoms suggestive of malaria and VL.
- •5. Having positive or negative results of tests for malaria and/or VL
- •6. Having a body temperature below 37.5°C.
- •7. Having no history of a clinical VL infection.
排除标准
- •The following exclusion criteria apply to all study components (cross-sectional, case-control and cohort):
- •1. Not giving their informed consent.
- •2. Showing signs or symptoms as the ones described for active VL or malaria, but with no laboratory confirmation of an ongoing malaria or VL infection (negative rk39 RDT and negative DAT for VL, and negative blood smear for malaria).
- •3. Having a Plasmodium parasite count >250,000/µL of blood.
- •4. Being already under drug treatment for malaria and/or VL.
- •5. Having a positive VL diagnosis in their medical history (in order to exclude false-positive VL diagnoses based on positive serology, and to exclude relapses).
- •6. Being pregnant.
- •7. Not living in the selected catchment area.
- •The following exclusion criteria apply specifically to all participants (clinically ill, asymptomatic and healthy) of the cohort study:
- •1. Being younger than 6 years.
- •2. Having a haemoglobin level of =7 g/dL.
- •3. Being diagnosed with malaria caused by a Plasmodium species different than P. falciparum.
- •4. Suffering from any other infectious disease, acute or chronic, different from malaria and/or VL, of which the patient has knowledge (e.g. tuberculosis, HIV, helminth infections).
- •5. Suffering from any immune system disorder, acute or chronic, of which the patient has knowledge, such as rheumatoid arthritis, asthma, leukaemia or immunosuppressive disorders.
- •6. Being under antimicrobial and/or anti-inflammatory treatment.
- •7. Being under immune-suppressive or immune-stimulatory treatment.
- •The following exclusion criteria apply to only the clinically ill patients of the follow-up cohort study:
- •1. Not eligible for first-line treatment for VL and/or malaria infection as stated in the national treatment guidelines (e.g. due to contraindication).
- •2. Being older than 30 years.
研究者
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