Malaria Clinical Trial
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
Verified date | January 2014 |
Source | Indonesia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Indonesia: National Agency of Drug and Food Control |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1488 |
Est. completion date | November 2013 |
Est. primary completion date | November 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Indonesia | Kecamatan Wewiku | Betun | East Nusa Tenggara |
Lead Sponsor | Collaborator |
---|---|
Indonesia University | Walter and Eliza Hall Institute of Medical Research |
Indonesia,
Shekalaghe SA, Drakeley C, van den Bosch S, ter Braak R, van den Bijllaardt W, Mwanziva C, Semvua S, Masokoto A, Mosha F, Teelen K, Hermsen R, Okell L, Gosling R, Sauerwein R, Bousema T. A cluster-randomized trial of mass drug administration with a gametocytocidal drug combination to interrupt malaria transmission in a low endemic area in Tanzania. Malar J. 2011 Aug 24;10:247. doi: 10.1186/1475-2875-10-247. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Malaria prevalence | Malaria prevalence in all age groups (only arm 1 and arm 2) | 3 months | No |
Other | Antimalaria antibody | Seroconversion rate of antimalaria antibody in all age groups (all arms) | 6 months | No |
Other | Infective vector | Oocyte and sporozoite rates in vector mosquitoes (all arms) | 3 months | No |
Other | Gametocyte carriage | Gametocyte carriage rate in all age groups (arm 1 and arm 2) | 3 months | No |
Other | Parasite genetic diversity | Genetic diversity of Plasmodium falciparum and P. vivax(arm 1 and arm 2) | 3 months | No |
Primary | Malaria incidence | Malaria incidence in children at the elementary schools (all arms) | 6 months | No |
Secondary | Anemia | Proportion of anemia in elementary school children (all arms) | 6 months | No |
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