Efficacy and safety of chloroquine for the treatment of uncomplicated Plasmodium vivax malaria in Mae Hong Son and Kanchanaburi provinces in Thailand
Bureau of Vector-borne Disease
100 participants
Aug 1, 2010
Interventional
Conditions
Summary
Title: Efficacy and safety of chloroquine for the treatment of uncomplicated Plasmodium vivax malaria in Mae Hong Son and Kanchanaburi provinces in Thailand Background: Current first-line treatment for P. vivax in Thailand is chloroquine. Study conducted in 2009 in 2 sentinel sites revealed high efficacy of the chloroquine (100%). The monitoring the efficacy of the first line treatment to generate valuable information for updating the national treatment policy is critical. Objective: To assess the efficacy and safety of chloroquine for the treatment of uncomplicated Plasmodium vivax malaria in Mae Hong Son and Kanchanaburi provinces in Thailand Methods: Antimalarial drug efficacy trials will be conducted in 2 sites. The participants will be febrile patients aged 6 months and above with confirmed uncomplicated P. vivax infection. Vivax malaria patients will be treated with Chloroquine 25 mg base/kg divided over 3 days; day 0, 5 mg base/kg per/meal for 3 meals; day 1, 5 mg/kg; day 2, 5 mg/kg. Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy for vivax malaria. The study will be conducted from July to December, 2010. The results of this study will be used to assist the Ministry of Public Health of Thailand in assessing the current national treatment guidelines for uncomplicated P. vivax malaria.
Eligibility
Inclusion Criteria7
- Age 6 months and above;
- Mono-infection with Plasmodium vivax for vivax malaria patients detected by microscopy
- P. vivax paraasitemia of >250/ul asexual forms
- presence of axillary or tympanic temperature equal or more than 37.5C or history of fever during the past 24 h
- Ability to swallow oral medication
- Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule and
- Informed consent from the patient or from a parent or guardian in the case of children
Exclusion Criteria1
- Presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO -mixed or mono-infection with another Plasmodium species detected by microscopy -presence of severe malnutrition (defined as a child whose growth standard is below -3 z-score, has symmetrical oedema involving at least the feet or has a mid-upper arm circumference <110 mm) -presence of febrile conditions due to diseases other than malaria or other known underlying chronic or severe diseases -Regular medication, which may interfere with antimalarial pharmacokinetics -history of hypersensitivity reactions or contraindications to any of the medicine being tested or used as alternative treatment -Female of child-bearing potential with ages 12-17 years old inclusive -A positive pregnancy test or breastfeeding -Unable to or unwilling to take contraceptives for pregnancy negative married women of child-bearing age
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Interventions
Oral chloroquine tablet (25 mg base/kg divided to be given over 3 days; day 0, 5 mg base/kg per/meal for 3 meals; day 1, 5 mg/kg; day 2, 5 mg/kg). In this trial, we study the efficacy of chloroquine alone for the treatment of uncomplicated vivax malaria. So we give Primaquine after study finished. The standard treatment of vivax malaria patient in Thailand is 25 mg base/kg divided to be given over 3 days plus primaquine 20 mg base taken daily for 14 days.
Locations(1)
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ACTRN12610000554066