Evaluation of a new product to treatment of malaria in Brazil.

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-77q7t3
• Date of registration: 10/06/2011
• Primary sponsor: Farmanguinhos-FIOCRUZ - Brazil
• Public title: Evaluation of a new product to treatment of malaria in Brazil.
• Scientific title: Study of efficacy and safety of a new co-blister packs of chloroquine and primaquine for malaria treatment of uncomplicated Plasmodium vivax in Brasil
• Date of first enrolment: 01/07/2011
• Target sample size: 88
• Recruitment status: not yet recruiting
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-77q7t3/
• Study design: Phase 2/3, single group, single-arm, therapeutic clinical trial.

Countries of recruitment

Brazil

Contacts

• Name: Dhelio Pereira
• Affiliation: CEPEM - Centro de Pesquisa em Medicina Tropical de Rondonia

• Name: Dhelio Pereira
• Affiliation: CEPEM - Centro de Pesquisa em Medicina Tropical de Rondonia

Key inclusion & exclusion criteria

Inclusion criteria: Age greather than or equal to 18 years and less than 65 years old or weight greather than 50 pounds a less than 80 pounds;
Mono infection with P. Vivax confirmed by microscopy;
Asexual parasite count greater than 250/ml;
Axillary temperature greater than 37.5 ° C or history of fever 48 hours before the enrollment;
Ability to swallow the drugs studied;
Willing and able to meet the schedule of study assessments;
Agree and sign an Informed Consent.



Exclusion criteria: Presence of clinical conditions related to vivax malaria requiring hospitalization (coma, respiratory dysfunction, or severe anemia);
Presence of febrile conditions because of another disease than malaria (for example, measles, acute respiratory tract infection, diarrhea with dehydration) or another chronic or severe comorbidities(for example: renal, cardiac or hepatic disease, and HIV / AIDS);
Use of drugs that may affect the pharmacokinetics of antimalarial drugs in study, such as antacids may reduce the chloroquine absorption , cimetidine because the pharmacological effects of chloroquine may be increased, Quinacrine given increase in the toxicity of primaquine and drugs that change gastrointestinal motility
, and in case of reported use of concomitant medications will be held on the database query Drug Interaction Checker (http://www.medscape.com/druginfo/druginterchecker?cid=med);
Hypersensitivity to drugs in study;
Presence of glucose-6-phosphate dehydrogenase, already known;
Any disease or clinically significant findings during the medical evaluation or physical examination that, in the investigator's opinion, may interfere with the study; However any decision will be recorded in the records of recruitment to avoid selection bias;
Pregnancy or lactation;
Indigenous;
Use of antimalarial treatment in a period less than 63 days before symptoms.








Age minimum: 18Y
Age maximum: 65Y
Gender: -

Health Condition(s) or Problem(s) studied

A00-B99

Malaria vivax
B51

Intervention(s)

Cloroquine 150 mg + Primaquine 15 mg (manufacture by FIOCRUZ - in accordance to the Brazilian recommendations). During 7 days. It will be treated 88 patients with uncomplicated malaria vivax.

Primary Outcome(s)

Clinical outcome (lack of fever, thus body temperature < 37 oC) and parasitological (tick smear negative for malaria by microscopy) at day 28.

Secondary Outcome(s)

Evaluate the Cloroquine plasma levels in filter paper at days 0, 7, 14, 21, 28.

Proportion of adverse events.

Secondary ID(s)

0001.0.046.000-11

Source(s) of Monetary Support

Programa Nacional de Controle de Malári - Brazil

Secondary Sponsor(s)

OPAS - Brazil