Comparison of Two Antimalarial Drugs Regimens in Patient With Plasmodium Vivax Malaria in Thailand

NCT01662700 | Unknown Phase 4

• 1 other identifier: FTM1202
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 4

Brief Summary

In Thailand, the proportion of P.vivax infection has now been increasing and is equal to Plasmodium falciparum since 1998. The incidence of P.vivax has recently been reported as 20 per 1000 population per year. Unlike Plasmodium falciparum, P.vivax infection rarely develops into complicated malaria and death is unusual. However, P.vivax has a dormant stage (the hypnozoite) that persists in the human liver and may cause relapse weeks, months, or even years later. Therefore, P.vivax infection is considered to have greater impact on morbidity than mortality, resulting in significant social and economic burden. Moreover, it is very difficult to control P.vivax transmission, because gametocytes appear almost simultaneously with schizonts. Radical treatment of the infection, therefore, normally consists of a blood schizontocidal course of chloroquine and a course primaquine for the elimination of the hypnozoites as anti-relapse therapy. In Thailand, chloroquine and primaquine have remained the mainstay chemotherapeutics for the treatment of P.vivax for more than 60 years and resistance has not yet been reported . The relapse rates at day 28 are about 50% without primaquine therapy and about 20% with standard primaquine therapy. Relapse has not been observed among patients receiving high dose primaquine therapy (30 mg daily for 14 days). Since January 2007, the evidence of reduced susceptibility of Plasmodium falciparum to artemisinins in Western Cambodia at Thai-Cambodia border was first presented and confirmed in a subsequent detailed pharmacokinetic-pharmacodynamic study. Nevertheless, a trend of gradual decline of in vitro sensitivity to chloroquine has been documented in some areas of the country, particularly Thai-Myanmar border. There has been no clinical-parasitological evidence of chloroquine resistant P.vivax in Thai-Cambodia border, Thailand. The objectives of the present study are to assess in vivo efficacy of first line regimen of chloroquine given with primaquine, and in vitro susceptibility of P.vivax isolates in areas along Thai-Cambodia border, Thailand.

Conditions

Acute Uncomplicated Malaria With P.Vivax Infection

Keywords

P. vivax infection; Artesunate; Chloroquine; Primaquine

Outcome Measures

Primary Outcomes (2)

• Parasite Clearance Rate

  Parasite clearance rate as defined by the slope of the linear portion of the natural logarithm parasite clearance curve

  7 days

• Relapse rate of P. vivax

  Incidence of relapse in P.vivax infection

  3 months

Secondary Outcomes (5)

• Parasite clearance time

  7 days

• Parasite density time

  7 days

• Fever clearance time

  7 days

• Proportion of patients with gametocytemia

  7 days

• In vitro antimalarial drug susceptibility

  7 days

Study Arms (2)

AS2

EXPERIMENTAL

Artesunate 2 mg/kg/day for 5 days Combine with * Primaquine 15 mg is given daily for 14 days. * Or primaquine 45 mg is given once a week for 8 weeks in G6PD deficiency patients.

Drug: Artesunate

Chloroquine

ACTIVE COMPARATOR

CH25: Chloroquine 25 mg/kg: 15 mg base/kg on the first days (D0), followed by 5 mg base/kg daily on the second and third day (day1-2) (total 25 mg base/ kg). Combine with * Primaquine 15 mg is given daily for 14 days. * Or primaquine 45 mg is given once a week for 8 weeks in G6PD deficiency patients.

Drug: Chloroquine

Interventions

Artesunate DRUG

AS2

Chloroquine DRUG

Chloroquine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged from 18 years to 65 years old who can come to the study hospital for follow up in case of re-infection
• Acute uncomplicated malaria with P.vivax infection, confirmed by positive blood smear with asexual forms of P. vivax with parasitaemia \> 1,000 parasites/microliters
• Fever defined as temperature \> 37.5 degree celsius or a history of fever within the last 24 hours
• Written informed consent
• Willingness and ability of the patients/guardians to comply with the study protocol for the duration of the study
• Communicate with Thai language

You may not qualify if:

• Mixed infection with other plasmodium species
• For females: pregnancy, breast feeding
• History of allergy or known contraindication to chloroquine, artesunate or primaquine
• Any criteria of severe / complicated malaria (WHO 2010)
• Presence of febrile condition caused by disease other than malaria.

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (4)

Khunhan Hospital

Si Sa Ket, Changwat Si Sa Ket, Thailand

RECRUITING

Kraburi Hospital

Ranong, Thailand

RECRUITING

Phusing Hospital

Si Sa Ket, Thailand

RECRUITING

Kap Choeng Hospital

Surin, Thailand

RECRUITING

MeSH Terms

Interventions

Artesunate; Chloroquine

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 Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2012
• First Posted: August 10, 2012
• Study Start: October 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 25, 2013

Record last verified: 2013-01

Locations

TH (4)