Study on the Treatment of Vivax Malaria

NCT01074905 | Completed Phase 3 DMC

• 1 other identifier: SMRU0908
• Study Type: interventional
• Target: 655
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomised open label trial with follow up for 1 year. 660 adults and children above 6 months diagnosed with acute Plasmodium vivax will be randomised into 3 groups, either chloroquine, artesunate, or chloroquine/primaquine therapy. Participants will be screened on the day of inclusion then followed weekly for 8 visits and every 4 weeks until week 52. The primary objective of the study is to compare the efficacy of the WHO and Thai Ministry of Public Health recommended radical curative regimen of chloroquine and primaquine with the currently used monotherapy regimens of chloroquine and artesunate along the Thai-Burmese border.

Conditions

Vivax Malaria

Keywords

vivax malaria; artesunate; chloroquine; primaquine; relapse

Outcome Measures

Primary Outcomes (1)

• The first recurrence of Plasmodium vivax malaria

  The first recurrence of Plasmodium vivax malaria within 28 days

  Day 28

Secondary Outcomes (5)

• Any recurrence of Plasmodium vivax parasitemia

  1 year

• Time to first recurrence, median time between episodes of vivax infections and total number of episodes

  1 year

• Overall number of days of illness and haematocrit below 30%

  1 year

• Chloroquine level

  Day 7

• Adverse events

  1 year

Study Arms (3)

Artesunate

ACTIVE COMPARATOR

2 mg/kg/day as single daily dose given for 5 days; maximum dose range is 1.6 to 2.4 mg/kg/day or a total of 8 to 12 mg/kg.

Drug: Artesunate

Chloroquine

ACTIVE COMPARATOR

25 mg base/kg given in divided doses (10,10,5) over 3 days; Absolute range 20-30 mg/kg.

Drug: Chloroquine

Chloroquine/Primaquine

EXPERIMENTAL

Chloroquine 3 days and Primaquine 14 days

Drug: Chloroquine/Primaquine

Interventions

Artesunate DRUG

2 mg/kg/day as single daily dose given for 5 days; maximum dose range is 1.6 to 2.4 mg/kg/day or a total of 8 to 12 mg/kg.

Artesunate

Chloroquine DRUG

25 mg base/kg given in divided doses (10,10,5) over 3 days; Absolute range 20-30 mg/kg.

Chloroquine

Chloroquine/Primaquine DRUG

Chloroquine 3 days and Primaquine 14 days

Chloroquine/Primaquine

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults and children \> 6 months
• Weight \> 7 kg for children
• Have not had primaquine since last Pv episode
• Participant (or parent/guardian if \< 18 years old) is willing and able to give written informed consent
• Microscopic diagnosis of Plasmodium vivax mono-infection
• Ability (in the investigators opinion) and willingness of patient or parent/guardian to comply with all study requirements

You may not qualify if:

• Allergy to artesunate, chloroquine or primaquine
• Severe malaria
• Patients with microscopic diagnosis of co-infection with Plasmodium falciparum
• Presence of any condition which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study
• Inability to tolerate oral medication
• Pregnancy
• Blood transfusion in the last 3 months
• Antimalarial in last 2 months

Sponsors & Collaborators

• University of Oxford: lead
• Mahidol University: collaborator

Study Sites (1)

Shoklo Malaria Research Unit

Mae Sot, Thailand

Location

Related Publications (3)

• Stadler E, Cromer D, Mehra S, Adekunle AI, Flegg JA, Anstey NM, Watson JA, Chu CS, Mueller I, Robinson LJ, Schlub TE, Davenport MP, Khoury DS. Population heterogeneity in Plasmodium vivax relapse risk. PLoS Negl Trop Dis. 2022 Dec 19;16(12):e0010990. doi: 10.1371/journal.pntd.0010990. eCollection 2022 Dec.

  PMID: 36534705 DERIVED

• Chu CS, Phyo AP, Lwin KM, Win HH, San T, Aung AA, Raksapraidee R, Carrara VI, Bancone G, Watson J, Moore KA, Wiladphaingern J, Proux S, Sriprawat K, Winterberg M, Cheah PY, Chue AL, Tarning J, Imwong M, Nosten F, White NJ. Comparison of the Cumulative Efficacy and Safety of Chloroquine, Artesunate, and Chloroquine-Primaquine in Plasmodium vivax Malaria. Clin Infect Dis. 2018 Oct 30;67(10):1543-1549. doi: 10.1093/cid/ciy319.

  PMID: 29889239 DERIVED

• Pratt B, Zion D, Lwin KM, Cheah PY, Nosten F, Loff B. Closing the translation gap for justice requirements in international research. J Med Ethics. 2012 Sep;38(9):552-8. doi: 10.1136/medethics-2011-100301. Epub 2012 Mar 16.

  PMID: 22427705 DERIVED

MeSH Terms

Conditions

Malaria, Vivax; Recurrence

Interventions

Artesunate; Chloroquine; Primaquine

Condition Hierarchy (Ancestors)

Malaria; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Organic Chemicals; Sesquiterpenes; Terpenes; Hydrocarbons; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Francois Nosten, MD

  Shoklo Malaria Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2010
• First Posted: February 24, 2010
• Study Start: May 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: August 28, 2013

Record last verified: 2013-08

Locations

TH (1)