Uncomplicated Plasmodium vivax Malaria
Conditions
Interventions
The study foresees the inclusion of 264 participants, which will be divided into 3 groups. The control group included 88 participants who will receive 150 mg Chloroquine produced by Farmaguinhos / Fio
Group 2 included 88 participants who will receive fixed-dose combination of artesunate and mefloquine, 100 +200 mg tablets produced by Farmaguinhos / Fiocruz + primaquine 15 mg produced by Farmaguinho
group 3 included 88 participants who will receive fixed-dose combination of artemether and lumefantrine tablets 20 + 120 mg produced by CIPLA + primaquine 15 mg produced by Farmaguinhos / Fiocruz, ora
Drug
D03.438.810.410
D03.438.810.050.650
D03.438.810.050.180
D27.505.954.122.250.100.085
Sponsors
Fundação Oswaldo Cruz
Fundação Oswaldo Cruz
Eligibility
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Age between 18 and 70, or weight between 50 kg and 80 kg; Mono-infection by P. Vivax confirmed by microscopy; Asexual parasite count > 250/µl; Axillary temperature > 37,5 °C or history of fever during the 48h prior to recruitment; Ability to swallow the medicaments under study; Availability and desire to observe the schedule of evaluations of the study; Agreement with and signing of the Term of Free and Informed Consent.
Exclusion criteria
Exclusion criteria: Presence of clinical conditions related to malaria vivax that require hospitalization (coma, respiratory dysfunction or severe anemia); Presence of febrile conditions due to another disease besides malaria (for example, measles, acute infection of the respiratory tract, diarrhea with dehydration) or other chronic or severe comorbidities (for example, kidney, cardiac or chronic liver disease, and HIV/AIDS); Use of medicaments that can interfere in the pharmacokinetics of the antimalarial medicaments under study; Hypersensibility to the medicaments under study; History of the presence of deficiency of glucose-6-phosphate dehydrogenase; Any significant disease or clinical findings during the medical evaluation or physical examination that the investigator considers might interfere in the study; Pregnancy (confirmed by ? HCG) or breastfeeding; Use of antimalarial treatment less than 63 days prior to the symptoms.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of adequate clinical and parasitological response and overall success or treatment failure at day 28, 42 and 63. Therapeutic success is defined as absence of parasitaemia on day 28, 42 and 63 regardless of axillary temperature in patients who have not previously met any of the criteria for treatment failure. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Reporting of any adverse effects a. Proportion of adverse events occurring in each phase of the treatment. This study will adapt the evaluation scale of the NCI Common Terminology Criteria for Adverse Events , which relates the occurring event with the medical treatment ;• Assessment of serum levels of chloroquine, mefloquine and lumefantrine, measured on filter paper on days 0,7, 14 21, 28, 42 and 63 | — |
Countries
Brazil
Contacts
Public ContactÉlisson ;Rosilene Souto;Ruffato
IPEPATRO - Instituto de Pesquisas em Patologias Tropicais;IPEPATRO - Instituto de Pesquisas em Patologias Tropicais
Outcome results
None listed