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Trial record 12 of 1405 for:    Peru

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

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ClinicalTrials.gov Identifier: NCT00164216
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : September 11, 2012
Sponsor:
Collaborator:
National Institute of Health, Peru
Information provided by (Responsible Party):
Centers for Disease Control and Prevention

Brief Summary:
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 or disease Intervention/treatment
Malaria Falciparum Drug: mefloquine plus artesunate

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Study Type : Observational
Actual Enrollment : 208 participants
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
Study Start Date : March 2005
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria





Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00164216


Locations
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Peru
Loreto Healthcare Facility
Iquitos, Loreto, Peru
Sponsors and Collaborators
Centers for Disease Control and Prevention
National Institute of Health, Peru
Investigators
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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

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Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT00164216     History of Changes
Other Study ID Numbers: CDC-NCID-4476
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: September 11, 2012
Last Verified: September 2012
Keywords provided by Centers for Disease Control and Prevention:
malaria
combination therapy
mefloquine
artesunate
Peru
malaria, uncomplicated
Additional relevant MeSH terms:
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Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Artesunate
Mefloquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics