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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

208 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-03-31

Study Completion Date

2008-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Malaria Falciparum

Keywords

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malaria combination therapy mefloquine artesunate Peru malaria, uncomplicated

Study Design

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Study Time Perspective

PROSPECTIVE

Interventions

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mefloquine plus artesunate

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexandre Macedo de Oliveira, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Centers for Disease Control and Prevention

Wilmer Marquiño Quezada, MD

Role: PRINCIPAL_INVESTIGATOR

National Institute of Health, Peru

Locations

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Loreto Healthcare Facility

Iquitos, Loreto, Peru

Site Status

Countries

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Peru

Other Identifiers

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CDC-NCID-4476

Identifier Type: -

Identifier Source: org_study_id