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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Health, Peru
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00164216
First received: September 9, 2005
Last updated: September 10, 2012
Last verified: September 2012
  Purpose

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)
  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00164216

Locations
Peru
Loreto Healthcare Facility
Iquitos, Loreto, Peru
Sponsors and Collaborators
National Institute of Health, Peru
Investigators
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

No publications provided

Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT00164216     History of Changes
Other Study ID Numbers: CDC-NCID-4476
Study First Received: September 9, 2005
Last Updated: September 10, 2012
Health Authority: United States: Federal Government
Peru: Ministry of Health

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

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Mefloquine
Artesunate
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Amebicides

ClinicalTrials.gov processed this record on July 20, 2014