Evaluation of Reactive Focal Mass Drug Administration for Malaria Elimination in Swaziland

• Status: Completed
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Francisco
• Collaborators: Clinton Health Access Initiative, Eswatini; Clinton Health Access Initiative, Nigeria; Ministry of Health, Swaziland; University of Texas
• Treatments: Artemisinins; Artenimol; Dihydroartemisinin; Piperaquine

Criteria

RACD Inclusion Criteria:

• 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

RACD Exclusion Criteria:

• 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