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

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ClinicalTrials.gov Identifier: NCT02315690
Recruitment Status : Completed
First Posted : December 12, 2014
Last Update Posted : October 30, 2017
Sponsor:
Collaborators:
Ministry of Health, Swaziland
Clinton Health Access Initiative, Nigeria
University of Texas
Information provided by (Responsible Party):
University of California, San Francisco

Brief 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.

Condition or disease Intervention/treatment Phase
Malaria Drug: dihydroartemisinin-piperaquine (DHAp) Procedure: reactive case detection Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4000 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : September 2015
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Active Comparator: 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.
Procedure: reactive case detection
Individuals in RACD target areas will be tested by RDT and if positive will be taken to the nearest health facility for treatment as per program operating procedures.
Other Name: screen and treat; test and treat

Experimental: 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).
Drug: dihydroartemisinin-piperaquine (DHAp)
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).
Other Name: Eurartesim




Primary Outcome Measures :
  1. Incidence of malaria cases [ Time Frame: 2 years ]
    Cumulative incidence of malaria cases by locality


Secondary Outcome Measures :
  1. Seroprevalence [ Time Frame: during end line survey after intervention data collection completed ]
    Prevalence of antibody response to markers of recent malaria exposure in target areas

  2. Prevalence [ Time Frame: during end line survey after intervention data collection completed ]
    Prevalence of infection by loop mediated isothermal amplification (LAMP) in target areas

  3. Coverage [ Time Frame: 2 years ]
    Proportion of persons residing within approximately 200 m of the index case who consented to participate in the study and who completed the initial procedures for their study arm (finger prick for RDT (rapid diagnostic test) in the RACD arm, initial dose of DHAp in the fMDA arm)

  4. Adherence [ Time Frame: 2 years ]
    Proportion of persons who completed 3 days of therapy among all individuals initiated on fMDA as assessed by pill count in the first intervention per study locality

  5. Safety related to DHAp [ Time Frame: 2 years ]
    Number of participants experiencing serious adverse events (SAEs) deemed possibly, probably, or definitely related to DHAp

  6. Acceptability [ Time Frame: 2 years ]
    Qualitative assessment among individuals residing in target areas and with surveillance agents.

  7. Cost [ Time Frame: 2 years ]
    Cost per index case-level intervention, cost per case averted, collected in 10 RACD and 10 fMDA events.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315690


Locations
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Swaziland
Swaziland Ministry of Health
Mbabane, Swaziland
Sponsors and Collaborators
University of California, San Francisco
Ministry of Health, Swaziland
Clinton Health Access Initiative, Nigeria
University of Texas
Investigators
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Principal Investigator: Michelle S Hsiang, MD UTSW, UCSF

Publications:

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02315690     History of Changes
Other Study ID Numbers: Swaziland fMDA
First Posted: December 12, 2014    Key Record Dates
Last Update Posted: October 30, 2017
Last Verified: October 2017

Keywords provided by University of California, San Francisco:
malaria, Swaziland, reactive case detection, focal mass drug administration

Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases
Piperaquine
Dihydroartemisinin
Artemisinins
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents