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

• Register: ClinicalTrials.gov
• Last refreshed on: 13 September 2021
• Main ID: NCT02315690
• Date of registration: 08/12/2014
• Prospective Registration: Yes
• Primary sponsor: University of California, San Francisco
• Public title: Evaluation of Reactive Focal Mass Drug Administration for Malaria Elimination in Swaziland fMDA
• Scientific title: 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
• Date of first enrolment: September 2015
• Target sample size: 4000
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02315690
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Swaziland

Contacts

• Name: Michelle S Hsiang, MD
• Affiliation: UTSW, UCSF

Key inclusion & exclusion 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 > 38.0°C, 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



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Malaria

Intervention(s)

Drug: dihydroartemisinin-piperaquine (DHAp)

Procedure: reactive case detection

Primary Outcome(s)

Incidence of malaria cases [Time Frame: 2 years]

Secondary Outcome(s)

Cost [Time Frame: 2 years]

Prevalence [Time Frame: during end line survey after intervention data collection completed]

Safety related to DHAp [Time Frame: 2 years]

Acceptability [Time Frame: 2 years]

Seroprevalence [Time Frame: during end line survey after intervention data collection completed]

Coverage [Time Frame: 2 years]

Adherence [Time Frame: 2 years]

Secondary ID(s)

Swaziland fMDA

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Texas

Clinton Health Access Initiative, Eswatini

Ministry of Health, Swaziland