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Surveillance and Treatment With Dihydroartemisinin-piperaquine Plus Primaquine

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ClinicalTrials.gov Identifier: NCT01878357
Recruitment Status : Completed
First Posted : June 14, 2013
Last Update Posted : January 24, 2014
Sponsor:
Collaborator:
Walter and Eliza Hall Institute of Medical Research
Information provided by (Responsible Party):
Inge Sutanto, Indonesia University

Brief Summary:

Mass Drug Administration (MDA) and Mass Screening and Selective Treatment (MST) might be applied as strategies for eliminating malaria when focusing on transmission stages. Many studies either with MDA or MST has been done in low transmission areas demonstrated the impact of those activities to reduce malaria transmission. However, in high transmission such study is still very limited which is becoming the reason behind this study.

A randomized cluster trial of MST study using dihydroartemisinin-piperaquine plus primaquine (DHP + PQ) will be conducted in some villages at the Belu regency, Nusa Tenggara TImur province, Central Indonesia. There will be three arms in the study, i.e. (1) intervention arm of mass screening and treatment with interval of 6 weeks; (2) intervention arm of mass screening and treatment with interval of 3 months and (3) control arm without mass screening and treatment. The intervention arm with 6 weeks interval represents a new proposed method to detection malaria infections, while the intervention arm with 3 month interval represents the Ministry of Health current policy of active case detection in Indonesia, and the third arm will serve as the control for Ministry of Health's policy.

The study will be conducted in 6 months period and evaluate various parameters including malaria incidence and proportion of anemia in monthly cohort school children (in arm1, 2 and 3), in addition to malaria prevalence in the community (only in arm 1 and arm 2). All positive subject in all arms will receive supervised treatment. Secondary objectives are the proportion of gametocytemia in the community, the proportion of malaria antibody of various age groups, population genetic of local parasite, submicroscopic incidence based polymerase chain reaction and the proportion of infective mosquitoes. Data analysis will be performed according to the method for cluster randomized trial evaluation.


Condition or disease Intervention/treatment Phase
Malaria Drug: dihydroartemisinin-piperaquine Drug: primaquine Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1488 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Mass Screening and Selective Treatment With Dihydroartemisinin-piperaquine Plus Primaquine on Malaria Transmission in High Endemic Area, Belu Regency, Nusa Tenggara Timur Province, Indonesia: a Randomized Cluster Trial
Study Start Date : June 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Experimental: DHP monthly
Three mass screening and selective treatment using dihydroartemisinin-piperaquine and primaquine i.e. on month 1 (MST1), month 2 (MST2), and month 3 (MST3) with an interval of 6 weeks between each MST
Drug: dihydroartemisinin-piperaquine
Treatment will be given to all malaria-positive individuals on microscopic examination. The dosage will be calculated based on body weight. The drug that will be given is 3-day dihydroartemisinin-piperaquine (DHP) treatment. The drug will be given by health care personnel at their houses assisted by health care volunteers of the integrated health post (Posyandu cadre).
Other Name: D-artepp

Drug: primaquine
One day primaquine (PQ) treatment will be given for P. falciparum infected subjects. For patients who are infected by P. vivax and P. ovale,PQ will be given for 14 days
Other Name: PQ

Experimental: DHP bi-monthly
Two mass screenings and selective treatment using dihydroartemisinin-piperaquine and primaquine i.e. on month 1 (MST1) and month 3 (MST3) with an interval of 3 months.
Drug: dihydroartemisinin-piperaquine
Treatment will be given to all malaria-positive individuals on microscopic examination. The dosage will be calculated based on body weight. The drug that will be given is 3-day dihydroartemisinin-piperaquine (DHP) treatment. The drug will be given by health care personnel at their houses assisted by health care volunteers of the integrated health post (Posyandu cadre).
Other Name: D-artepp

Drug: primaquine
One day primaquine (PQ) treatment will be given for P. falciparum infected subjects. For patients who are infected by P. vivax and P. ovale,PQ will be given for 14 days
Other Name: PQ

No Intervention: Arm 3
Without MST



Primary Outcome Measures :
  1. Malaria incidence [ Time Frame: 6 months ]
    Malaria incidence in children at the elementary schools (all arms)


Secondary Outcome Measures :
  1. Anemia [ Time Frame: 6 months ]
    Proportion of anemia in elementary school children (all arms)


Other Outcome Measures:
  1. Malaria prevalence [ Time Frame: 3 months ]
    Malaria prevalence in all age groups (only arm 1 and arm 2)

  2. Antimalaria antibody [ Time Frame: 6 months ]
    Seroconversion rate of antimalaria antibody in all age groups (all arms)

  3. Infective vector [ Time Frame: 3 months ]
    Oocyte and sporozoite rates in vector mosquitoes (all arms)

  4. Gametocyte carriage [ Time Frame: 3 months ]
    Gametocyte carriage rate in all age groups (arm 1 and arm 2)

  5. Parasite genetic diversity [ Time Frame: 3 months ]
    Genetic diversity of Plasmodium falciparum and P. vivax(arm 1 and arm 2)



Information from the National Library of Medicine

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

Inclusion Criteria:

  • All villagers of the all selected clusters

Exclusion Criteria:

  • Pregnant women during their first trimester
  • Single dose primaquine should not be given for infants less than 1 year-old, pregnant women in all trimesters of pregnancy, breast-feeding mother and patients with G6PD deficiency

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): NCT01878357


Locations
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Indonesia
Kecamatan Wewiku
Betun, East Nusa Tenggara, Indonesia, 85762
Sponsors and Collaborators
Indonesia University
Walter and Eliza Hall Institute of Medical Research

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Inge Sutanto, Prof. DR. dr., Indonesia University
ClinicalTrials.gov Identifier: NCT01878357     History of Changes
Other Study ID Numbers: MTC Belu
First Posted: June 14, 2013    Key Record Dates
Last Update Posted: January 24, 2014
Last Verified: January 2014

Keywords provided by Inge Sutanto, Indonesia University:
MST
Malaria
Indonesia
Transmission

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