Acute Uncomplicated Malaria With P.Vivax Infection Clinical Trial
Official title:
An Open Label Randomized Comparison of Two Antimalarial Drugs Regimens in Patient With Plasmodium Vivax Malaria in Thailand
| Verified date | January 2013 |
| Source | Mahidol University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Thailand: Ethical Committee |
| Study type | Interventional |
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.
| Status | Recruiting |
| Enrollment | 120 |
| Est. completion date | December 2014 |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Thailand | Kraburi Hospital | Ranong | |
| Thailand | Khunhan Hospital | Srisaket | |
| Thailand | Phusing Hospital | Srisaket | |
| Thailand | Kap Choeng Hospital | Surin |
| Lead Sponsor | Collaborator |
|---|---|
| Mahidol University |
Thailand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Parasite Clearance Rate | Parasite clearance rate as defined by the slope of the linear portion of the natural logarithm parasite clearance curve | 7 days | No |
| Primary | Relapse rate of P. vivax | Incidence of relapse in P.vivax infection | 3 months | No |
| Secondary | Parasite clearance time | Parasite clearance time assessed by microscopy | 7 days | No |
| Secondary | Parasite density time | Time of parasite count to fall to 50%, 90% and 99% of initial parasite density | 7 days | No |
| Secondary | Fever clearance time | Fever clearance time (i.e. the time taken for temperature to fall below 37 degrees celsius and remain there for at least 24 hrs) | 7 days | No |
| Secondary | Proportion of patients with gametocytemia | Proportion of patients with gametocytemia before, during and after treatment, assessed at admission, on day 3 stratified by presence of gametocytes at enrolment | 7 days | No |
| Secondary | In vitro antimalarial drug susceptibility | IC0, IC90, IC99 of Plasmodium vivax responses to antimalarial drugs ( ex vivo) | 7 days | No |