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

NCT00164216 | Completed

• 1 other identifier: CDC-NCID-4476
• Study Type: observational
• Target: 208
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria Falciparum

Keywords

malaria; combination therapy; mefloquine; artesunate; Peru; malaria, uncomplicated

Interventions

mefloquine plus artesunate DRUG

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead
• National Institute of Health, Peru: collaborator

Study Sites (1)

Loreto Healthcare Facility

Iquitos, Loreto, Peru

Location

MeSH Terms

Conditions

Malaria, Falciparum; Malaria

Interventions

Mefloquine; Artesunate

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Organic Chemicals; Sesquiterpenes; Terpenes; Hydrocarbons

Study Officials

• Alexandre Macedo de Oliveira, MD, MSc

  Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• Wilmer Marquiño Quezada, MD

  National Institute of Health, Peru

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 14, 2005
• Study Start: March 1, 2005
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: September 11, 2012

Record last verified: 2012-09

Locations

PE (1)