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

Malaria Falciparum Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00164216
• Other study ID #: CDC-NCID-4476
• Status: Completed
• Phase: Phase 4
• First received: September 9, 2005
• Last updated: September 10, 2012
• Start date: March 2005
• Est. completion date: March 2008

Study information

• Verified date: September 2012
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentPeru: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year and older

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Malaria
• Malaria Falciparum
• Malaria, Falciparum

Intervention

Drug:
• mefloquine plus artesunate

Locations

Country	Name	City	State
Peru	Loreto Healthcare Facility	Iquitos	Loreto

Sponsors (2)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	National Institute of Health, Peru

Country where clinical trial is conducted

Peru,