Evaluating the Effectiveness and Feasibility of Reactive Focal Mass Drug Administration vs. Reactive Case Detection as a Community Level Intervention in Response to a Passively Identified Index Malaria Case in Swaziland
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 4,000
- 试验地点
- 1
- 主要终点
- Incidence of malaria cases
研究概览
简要总结
This is a cluster randomised controlled trial comparing the impact of two community based malaria interventions: reactive case detection (RACD) vs reactive targeted presumptive treatment (focal mass drug administration, fMDA) on the incidence of malaria in Swaziland.
详细描述
Title Evaluating the effectiveness and feasibility of reactive focal mass drug administration (fMDA) vs. reactive case detection (RACD) as a community level intervention in response to a passively identified index malaria case in Swaziland
Study design Cluster randomised controlled trial
Aims
Primary aim: To compare the impact of fMDA versus RACD on malaria incidence.
Secondary aims
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Index case resides in study locality
- •All non-index cases that reside or spent at least one night in the Target Area in the past 5 weeks
- •Non-index case resides within 200 meters of index case unless study team was not able to recruit 30 individuals by 3rd visit, in which case non-index case individuals may reside up to 500 meters from index case
- •Provide informed consent
排除标准
- •Refusal to participate
- •Target Area overlaps with prior RACD Target Area from within the past 5 weeks
- •fMDA Inclusion Criteria:
- •Index case resides in study locality
- •All non-index cases that reside or have spent at least one night in the Target Area in the past 5 weeks
- •Non-index case resides within 200 meters of index case unless study team was not able to recruit 30 individuals by 3rd visit, in which case non-index case individuals may reside up to 500 meters from index case
- •Provide informed consent
- •fMDA Exclusion Criteria:
- •Refusal to participate
- •Temperature > 38.0⁰C, report of fever in the past 48 hours, or other illness (will be referred to the nearest health facility for further evaluation)
- •fMDA Target Area overlaps with prior Target Area within the past 8 weeks
- •For fMDA specifically (though still eligible for follow-up blood survey):
- •Pregnancy, breastfeeding, and women who have had menarche but no menses in the past 4 weeks
- •Children less than 6 months of age or <5 kg
- •Known allergy or history of adverse reaction to DP (still eligible for f/u blood surveys)
- •Already taken 2 courses of DP in the past year or taken 1 course within the past 2 months
- •Moderate or severe renal or hepatic insufficiency
- •Currently with severe malaria
- •Family history of sudden death or of congenital prolongation of the QTc (correct QT interval) interval.
- •Known congenital prolongation of the QTc-interval or any clinical condition known to prolong the QTc interval.
- •History of symptomatic cardiac arrhythmias or with clinically relevant bradycardia. Any predisposing cardiac conditions for arrhythmia such as severe hypertension, left ventricular hypertrophy (including hypertrophic cardiomyopathy) or congestive cardiac failure accompanied by reduced left ventricle ejection fraction.
- •Electrolyte disturbances, particularly hypokalaemia, hypocalcaemia or hypomagnesaemia (including vomiting in child)
- •Taking medicinal products that are known to prolong the QTc interval. See note for list of drugs.
- •Recent treatment with medicinal products known to prolong the QTc interval that may still be circulating at the time that Eurartesim is commenced (e.g. mefloquine, halofantrine, lumefantrine, chloroquine, quinine and other antimalarial agents) taking into account their elimination half-life
- •NOTE: Medicinal products that are known to prolong the QTc interval include:
- •Antiarrhythmics (e.g. amiodarone, disopyramide, dofetilide, ibutilide, procainamide, quinidine, hydroquinidine, sotalol).
- •Neuroleptics (e.g. phenothiazines, sertindole, sultopride, chlorpromazine, haloperidol, mesoridazine, pimozide, or thioridazine), antidepressive agents.
- •Certain antimicrobial agents, including agents of the following classes: - macrolides (e.g. erythromycin, clarithromycin), - fluoroquinolones (e.g. moxifloxacin, sparfloxacin), - imidazole and triazole antifungal agents, - and also pentamidine and saquinavir.
- •Certain non-sedating antihistamines (e.g. terfenadine, astemizole, mizolastine).
- •Cisapride, droperidol, domperidone, bepridil, diphemanil, probucol, levomethadyl, methadone, vinca alkaloids, arsenic trioxide
研究组 & 干预措施
Reactive case detection (RACD)
Individuals in RACD Target Areas will be tested by RDT (rapid diagnostic test) and if positive, taken to the nearest health facility for treatment with artemether-lumefantrine per national policy.
干预措施: reactive case detection (Procedure)
Reactive focal mass drug administration (fMDA)
In the fMDA arm, all individuals in the Target Area will receive dihydroartemisinin-piperaquine (DHAp) once daily for 3 days with the first dose taken no later than 5 weeks from the index case presentation (goal within one week).
干预措施: dihydroartemisinin-piperaquine (DHAp) (Drug)
结局指标
主要结局
Incidence of malaria cases
时间窗: 2 years
Cumulative incidence of malaria cases by locality
次要结局
- Acceptability(2 years)
- Safety related to DHAp(2 years)
- Prevalence(during end line survey after intervention data collection completed)
- Coverage(2 years)
- Adherence(2 years)
- Cost(2 years)
- Seroprevalence(during end line survey after intervention data collection completed)