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The Averting Readmissions for Malaria and Outpatient Reinfections (ARMOR) Trial

避免疟疾和门诊再感染再入院 (ARMOR) 试验

基本信息

批准号：
10328316
负责人：
Matthew Michael Ippolito
金额：
$ 24.56万
依托单位：
JOHNS HOPKINS UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-07-18 至 2024-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10328316
关键词：
15 year old Acute Address Adherence Adult Africa South of the Sahara Antimalarials Area Beds Blood Case Management Cessation of life Chemoprophylaxis Child Childhood Chloroguanide Clinical Clinical Trials Clinical Trials Design Documentation Dose Drug Kinetics Enrollment Entomology Erythrocytes Face Falciparum Malaria Funding Health Hepatic Hospitalization Hospitalized Child Hospitals Household Human Immunity Incidence Infection Infrastructure Inpatients Insecticides Intervention Liver Malaria Malaria prevention Measures Morbidity - disease rate Outcome Outpatients Parasitemia Parasites Participant Patients Pediatric Hospitals Pharmacodynamics Placebos Plasmodium falciparum Preparation Preventive measure Preventive treatment Prophylactic treatment Public Health Randomized Randomized Controlled Trials Recurrence Research Research Personnel Residual state Resources Risk Role Safety Secondary Prevention Secondary to Site Testing Time United States National Institutes of Health Vector Ecology Zambia atovaquone base cost decamethrin design effectiveness evaluation effectiveness testing evidence base high risk high risk population hospital readmission improved improved outcome indexing infection risk innovation international center mortality novel novel strategies patient population pediatric patients prevent primary outcome public health priorities readmission risk recurrent infection standard of care transmission process vector vector control vector mosquito

项目摘要

PROJECT SUMMARY/ABSTRACT Malaria due to Plasmodium falciparum is a public health priority in sub-Saharan Africa and other endemic areas, yet clinical interventions for severe malaria remain understudied. Children who survive a hospitalized episode of severe malaria remain at increased risk of morbidity and mortality for as long as 18 months post- discharge, mainly due to recurrent malaria. Thus, children who are convalescent from severe malaria represent a high-risk population who stand to benefit from interventions that prevent recurrent malaria. A small number of prior studies have tested intermittent preventive treatment-based approaches with equivocal results. We propose to test the effectiveness of a novel approach using secondary chemoprophylaxis with the causally- active antimalarial (i.e., against the liver-stage of the parasite), atovaquone-proguanil (AP), and reactive focal vector control with indoor residual spraying (rf-IRS) both alone and in combination. The objective of this proposal is to develop the study materials and prepare for the implementation of a randomized factorial design clinical trial to test the role of secondary chemoprophylaxis and reactive focal vector control in improving severe malaria outcomes during the post-discharge period where children are at high risk of hospital readmission and death due to recurrent malaria. The trial site in Nchelenge District, Zambia is a high burden area with sustained transmission throughout the year and where severe malaria accounts for up to one-third of pediatric hospital admissions at any given time. This study will leverage substantial infrastructure from the NIH- funded International Centers of Excellence for Malaria Research. The central hypothesis is that the risk of P. falciparum reinfection following an episode of severe malaria can be averted by the combination of causal prophylaxis using AP and vector control using rf-IRS. We expect that AP prophylaxis and rf-IRS will reduce morbidity and mortality in children convalescent from severe falciparum malaria. The innovation of the study includes in its use of AP for secondary chemoprophylaxis—uniquely notable for its hepatic as well as blood schizonticidal activity, in contrast to other available agents which are limited to blood-stage parasites—and a novel application of focal vector control in an understudied, high-risk population. The proposed trial is significant because it will furnish evidence to inform the case management of severe malaria which has seen little advancement in the preceding decades. It will test the effectiveness of secondary chemoprophylaxis and rf-IRS, alone and in combination, among a high-risk patient population with the potential to prevent an estimated 2.8 million rehospitalizations and over 100,000 deaths annually.

项目总结/文摘