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Efficacy and Effectiveness of Combined Therapy for Uncomplicated Malaria Treatment in Peru

This study has been completed.
National Institute of Health, Peru
Information provided by (Responsible Party):
Centers for Disease Control and Prevention Identifier:
First received: September 9, 2005
Last updated: September 10, 2012
Last verified: September 2012
This is a study of the efficacy and effectiveness of combination therapy for malaria due to P. falciparum in the Loreto Department, Iquitos, Peru. The investigators will enroll subjects ≥ 1 year-old who have a diagnosis of uncomplicated malaria due to P. falciparum. Patients will receive a treatment regimen consisting of mefloquine (25 mg/kg per day for two days) and artesunate (12 mg/kg per day for three days). Patients will be divided into two groups: one will receive drugs under direct supervision and the other will be instructed on how to take the drugs by themselves. Clinical and parasitologic response will be monitored for a follow-up period of 28 days. The findings of this study will be used to guide the Ministry of Health in evaluating its national policy for P. falciparum malaria treatment.

Condition Intervention Phase
Malaria Falciparum
Drug: mefloquine plus artesunate
Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Evaluation of the Efficacy and Effectiveness of Combined Therapy With Mefloquine and Artesunate for Uncomplicated Malaria Treatment in the Loreto Region (Amazon Basin), Peru

Resource links provided by NLM:

Further study details as provided by Centers for Disease Control and Prevention:

Enrollment: 208
Study Start Date: March 2005
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   1 Year and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age > 1 year
  • Axillary temperature ≥ 37.5ºC and/or history of fever in the previous 48 hours without any other evident cause
  • Unmixed infection with P. falciparum of between 250 and 100,000 asexual parasites/mm3 as determined by microscopic exam of the thick or thin smear
  • An informed consent obtained from the patient or his/her guardian (in case of patients ≤ 18 years old) and assent for children (8-18 years old)
  • Willingness to come to the health facility for the following 28 days

Exclusion Criteria:

  • Signs or symptoms of severe malaria
  • Other severe chronic diseases (e.g., cardiologic, renal, or hepatic diseases; HIV/AIDS; severe malnutrition)
  • History of allergy to any of the proposed treatment or its alternatives, i.e. mefloquine, artesunate, quinine, tetracycline, or clindamycin
  • Pregnancy (based on urine test), since this group of patients receives other drugs for malaria treatment in accordance with Peruvian national guidelines.
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Please refer to this study by its identifier: NCT00164216

Loreto Healthcare Facility
Iquitos, Loreto, Peru
Sponsors and Collaborators
Centers for Disease Control and Prevention
National Institute of Health, Peru
Principal Investigator: Alexandre Macedo de Oliveira, MD, MSc Centers for Disease Control and Prevention
Principal Investigator: Wilmer Marquiño Quezada, MD National Institute of Health, Peru
  More Information

Responsible Party: Centers for Disease Control and Prevention Identifier: NCT00164216     History of Changes
Other Study ID Numbers: CDC-NCID-4476
Study First Received: September 9, 2005
Last Updated: September 10, 2012

Keywords provided by Centers for Disease Control and Prevention:
combination therapy
malaria, uncomplicated

Additional relevant MeSH terms:
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Amebicides processed this record on May 23, 2017