Surveillance and Treatment With Dihydroartemisinin-piperaquine Plus Primaquine

NCT01878357 | Completed Phase 4 DMC

• 1 other identifier: MTC Belu
• Study Type: interventional
• Target: 1,488
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria

Keywords

MST; Malaria; Indonesia; Transmission

Outcome Measures

Primary Outcomes (1)

• Malaria incidence

  Malaria incidence in children at the elementary schools (all arms)

  6 months

Secondary Outcomes (1)

• Anemia

  6 months

Other Outcomes (5)

• Malaria prevalence

  3 months

• Antimalaria antibody

  6 months

• Infective vector

  3 months

Study Arms (3)

DHP monthly

EXPERIMENTAL

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; Drug: primaquine

DHP bi-monthly

EXPERIMENTAL

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; Drug: primaquine

Arm 3

NO INTERVENTION

Without MST

Interventions

dihydroartemisinin-piperaquine DRUG

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).

Also known as: D-artepp

DHP bi-monthly; DHP monthly

primaquine DRUG

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

Also known as: PQ

DHP bi-monthly; DHP monthly

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All villagers of the all selected clusters

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead
• Walter and Eliza Hall Institute of Medical Research: collaborator

Study Sites (1)

Kecamatan Wewiku

Betun, East Nusa Tenggara, 85762, Indonesia

Location

Related Publications (3)

• 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.

  PMID: 21864343 BACKGROUND

• Kosasih A, Koepfli C, Dahlan MS, Hawley WA, Baird JK, Mueller I, Lobo NF, Sutanto I. Gametocyte carriage of Plasmodium falciparum (pfs25) and Plasmodium vivax (pvs25) during mass screening and treatment in West Timor, Indonesia: a longitudinal prospective study. Malar J. 2021 Apr 9;20(1):177. doi: 10.1186/s12936-021-03709-y.

  PMID: 33836772 DERIVED

• Sutanto I, Kosasih A, Elyazar IRF, Simanjuntak DR, Larasati TA, Dahlan MS, Wahid I, Mueller I, Koepfli C, Kusriastuti R, Surya A, Laihad FJ, Hawley WA, Collins FH, Baird JK, Lobo NF. Negligible Impact of Mass Screening and Treatment on Mesoendemic Malaria Transmission at West Timor in Eastern Indonesia: A Cluster-Randomized Trial. Clin Infect Dis. 2018 Oct 15;67(9):1364-1372. doi: 10.1093/cid/ciy231.

  PMID: 29579195 DERIVED

MeSH Terms

Conditions

Malaria

Interventions

Primaquine

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. DR. dr.

Study Record Dates

• First Submitted: June 4, 2013
• First Posted: June 14, 2013
• Study Start: June 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: January 24, 2014

Record last verified: 2014-01

Locations

ID (1)